Pharmaceutical Service Reform in Italy from Unification to 2008

Pharmaceutical Service reform from the Italian Unity to beginning of 20th century
22

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LCC DG 201-365.

Raimondo Villano
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INDICE
Sintesi 15
Abstract 17
Résumé 19
Abstrakt 21
Abstracto 23
Part One - Recognition of maximum on pre-unification situation 27
1. Recognition of maximum on pre-unification situation 29
Part Two - From dawning of the unitary State to T.U.L.S. 33
2. Dawning of the unitary State 35
3. Crispi Law 36
4. Municipal pharmacy and public Pharmacy 37
5. Giolitti-Tedesco Law 37
6. Plant and municipal exercise of pharmacy, trade of herbs and
professional qualification
41
7. Consolidated Text of T.U.L.S. and Royal Decree 1265/34 41
Part Tree - From two postwar to ferorming Law 362/91 43
8. Postwar: reconstruction of professional Associations and
competition for remaining holders without seat
45
9. European Economic Community: article 57 of the Treaty of Rome 46
10. Crisis of the rural pharmacy 47
11. Mariotti Reform 47
12. National Health System, investments to pharmaceutical
expenditure, health reform 833/78
48
13. Law 892/1984 49
14. EEC Directives on free movement within the Community of
pharmacists
49
15. National Health Information System and Community instruments of 50

8
pharmaceutical economic evaluation
16. Law reforming of the pharmaceutical sector 362/1991 51
17. European Pharmacopoeia: adaptation program of national
monographs
51
Part Four - From deregulation symptoms to online pharmacies
and liberalisations
53
18. Legislative Decree 541/1992: the beginning of process of
deregulation undercurrent of pharmacy
55
19. Online pharmacies and privatizing community pharmacies 55
20. Galeotti Commission, competition between pharmacies,
outsourcing services and hospital pharmacy functions
56
21. Onofri Commission and Antitrust Authority 56
22. Pharmaceutical e-commerce and pharmacies in the network 56
23. Constitutional Court: judgments 27/2003 (hours, shifts and
holidays) and 275/2003 (intermediate and final distribution of drug)
59
24. Ministry of Health: traceability of drugs and the fight against
counterfeiting
60
25. European Commission: Bolkestein Directive on competition in
services and infringement proceedings against Italian Government
62
26. Storace Decree 87/2005 on pharmaceutical discounts 62
27. Development and criticality of online pharmacies, task force
IMPACT
63
28. Pharmacy transformation risks in supermarket and proposed sale of
medicines in supermarkets
64
29. Incompatibility of the Community legislation of Italian pharmacies:
Italy’s referral to the European Court of Justice
65
30. New rules on competition and consumer rights (Bersani Decree) 66
31. Corner of OTC drugs in supermarkets 68
32. Bersani Decree: reaction of pharmacies 68
33. Clarifications on applied aspects of Bersani Law 69
34. Hypermarket and hypopharmacist 70
35. Run the opening of ‘para-pharmacies’ and its effects 71
36. Progressive loss of professional dignity 72

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37. Importance of the pharmacist in the last thirty years 73
38. Dissemination of navigation for medical purposes on internet 74
39. Antitrust Authority’s actions on schedules, rosters and restrictions
of competition
75
40. Chamber of Deputies: work on fitness for ownership, staffing plan
and ‘c-list’
76
41. Reactions to deregulation of sale ‘c-list’ drugs with a medical
prescription
76
42. Analysis of impact of deregulation of ‘c-list’ on pharmaceutical
service
82
43. Opening of first corner ‘Stop Health’ on the highway 85
44. Council of Europe: Resolution ResAP2007/2 distribution of
medicinal send by mail
86
45. Favourable opinion AIFA on the morning after pill RU 486 and
conscientious objection
87
46. Emergency dispensing of the drug without a prescription
(Ministerial Decree 31 March 2008)
89
47. Large-scale distribution: entry into the market for the production of
drugs
91
48. Foreign chains of pharmacies and their ownership 92
49. European Court of Justice: intervention by the Italian government
in defense of the pharmacy
93
50. First Municipal drugstore 93
51. Shares of regional redetermination quorum of pharmacies 94
52. European Court of Justice: because of free movement of capital and
establishment
95
53. Generic drugs or equivalent biotech drugs and biosimilars 96
54. Notes 101
55. Author profile 115

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“This is the first rule to write history:
do not dare say the false and then do not rush do not say the truth,,
there is no suspicion that the pen writes in favor or unfavorable”
Pope Leo XIII
Apostolic Letter “Saepenumero considerantes” (August 18, 1883)

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Parole chiave
Servizio farmaceutico; Riforma sanitaria; Legge Crispi; Legge Giolitti;
T.U.L.S.; Legge 833/78; Direttiva Bolkestein; Concorrenza farmacie;
Antitrust farmaceutico; Farmacie online; Tracciabilità dei farmaci;
Contraffazione dei farmaci; Grande distribuzione organizzata; Decreto
Storace; Decreto Bersani; Parafarmacie; Deregolamentazione farmaceutica;
Obiezione di coscienza; Dispensazione d’emergenza; Liberalizzazioni;
Farmaci generici; Farmaci biosimilari; Libera circolazione di capitali;
Libera circolazione di stabilimento; Regno d’Italia; Repubblica italiana;
Corte Costituzionale; Ministero della Salute; Unione Europea; Corte di
Giustizia Europea.
Keywords
Pharmaceutical services; Health care reform; Crispi law; Giolitti law;
T.U.L.S.; Law 833/78; Competition pharmacies; Antitrust pharmaceuticals;
Online pharmacies; Traceability of medicines; Counterfeiting of medicines;
Big Organised distribution; Storace decree; Bersani decree; Para-pharmacy;
Deregulation of pharmaceutical industry; Conscientious objection;
Emergency dispensation; Liberalizations; Generics; Biosimilars; Free
movement of capital; Free movement of establishment; Kingdom of Italy;
Italian republic; Constitutional Court; Ministry of Health; European Union;
European Court of Justice.
Classification LCC
DG 201-365.
Title
Reform of the pharmaceutical service from the Unification of Italy at the
beginning of yhe twenty-first century.

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Raimondo Villano
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Sintesi
Partendo da una ricognizione di massima sulla situazione preunitaria da
inizio XIX secolo, si esaminano gli sviluppi del servizio farmaceutico nel
Regno d’Italia prima e nella Repubblica Italiana poi, giungendo a fine
2008, nonché le interrelazioni e le influenze principali a livello
Comunitario a partire dai Trattati di Roma del 1957. Dunque,
dall’unificazione legislativa si giunge all’istituzione del servizio sanitario
nazionale, ai provvedimenti iniziali di contenimento della spesa
farmaceutica, ai prodromi di deregolamentazione, sino alle farmacie
online e alle liberalizzazioni. Per una disamina più compiuta e ragionata,
all’occorrenza si ha anche cura di inquadrare i termini essenziali dei
principali fenomeni congiunturali e/o ‘collaterali’ inferenti sul servizio
farmaceutico. Infine, alla trattazione degli ultimi tre decenni circa è
riservata un’analisi ulteriormente particolareggiata e approfondita.

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Raimondo Villano
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Abstract
Starting from a reconnaissance of maximum on the pre-unification
situation from the beginning of the nineteenth century, we examine the
developments of the pharmaceutical service in the Kingdom of Italy first
and then in the Italian Republic, arriving in late 2008, as well as the
interrelationships and the main influences at Community level as the
Treaties of Rome in 1957. Thus, from the unification we arrive to
legislative institution of the national health service, to the initial measures
of containment of pharmaceutical expenditure, to the harbingers of
deregulation, ap to the e-pharmacy and liberalizations. For a more
complete discussion and reasoned, where it is necessary it will also care to
frame the essential terms of the main economic phenomena and/or
‘collateral’ inferencing on pharmaceutical services. Finally, to the
discussion of the last three decades or so is reserved a further detailed and
thorough analysis.

18

Raimondo Villano
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Résumé
À partir d’une enquête sérieuse sur la situation avant l’unification du début
du XIXe siècle, on examine les développements du service pharmaceutique
dans le Royaume d’Italie d’abord, puis dans la République italienne, en
arrivant à la fin de 2008, ainsi que les interrelations et les principales
influences au niveau Communautaire à partir des Traités de Rome en
1957. Ainsi, de l’unification on vien à l’institution du service national de
santé, aux premières mesures de maîtrise des dépenses pharmaceutiques,
aux signes avant-coureurs de déréglementation, jusu’à l’e-pharmacie et
aux libéralisations. Pour une analyse plus complète et motivée, à
l’occurrence, on aussi se soucie d’encadrer les conditions essentielles des
principaux phénomènes économiques et/ou inférences ‘collatéraux’ sur le
service pharmaceutique. Enfin, à la discussion des trois dernières
décennies environ est réservée une analyse particulairement détaillée et
approfondie.

20

Raimondo Villano
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Abstrakt
Ausgehend von einem groben überblick über die vor der wiedervereinigung
situation von anfang des neunzehnten jahrhunderts, untersuchen wir die
entwicklungen der pharmazeutischen dienst im Königreich Italien und
dann in der Italienischen Republik, ende 2008 ankommen, sowie die
zusammenhänge und die wichtigsten einflüsse auf gemeinschaftsebene die
Verträge von Rom im Jahr 1957. So wird die vereinigung legislative organ
der nationalen gesundheitsdienst nehmen, die ersten maßnahmen der
eindämmung der arzneimittelausgaben, die vorboten der deregulierung,
soweit die online-apotheke und liberalisierung. Für eine, vollständigere
Erörterung und begründete, falls erforderlich, wird es auch die
wesentlichen bedingungen der wichtigsten wirtschaftlichen phänomene
und/oder ‘sicherheiten’ inferenz auf pharmazeutische dienstleistungen zu
rahmen sorgen. Schließlich, ist die diskussion der letzten drei jahrzehnte
oder so für weitere detaillierte und gründliche analyse.

Raimondo Villano
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Abstracto
A partir de una encuesta dura sobre la situación previa a la unificación de
principios del siglo XIX, se analiza la evolución de la prestación
farmacéutica en el Reino de Italia primero y luego en la República
italiana, llegando a finales de 2008, así como las interrelaciones y las
principales influencias a nivel comunitario partiendo desde los Tratados de
Roma en 1957. Por lo tanto, desde la unificación institución legislativa
ilegada al servicio nacional de salud, hasta el medidas iniciales de
contención del gasto farmacéutico, hasta el precursores de la
desregulación, hasta el farmacia en línea y la liberalización. Para una
discusión más completa y razonada, si es necesario, también se
preocuparon por los términos esenciales de los principales fenómenos
económicos y/o inferencia ‘colaterales’ de servicio farmacéutico. Por
último, a la discusión de las últimas tres décadas o así se reserva un
análisis más detallado y exhaustivo.

24

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PHARMACEUTICAL SERVICE REFORM
FROM THE ITALIAN UNITY TO THE
BEGINNING OF THE TWENTIETH CENTURY

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54
PART FOUR
FROM DEREGULATION SYMPTONS
TO ONLINE PHARMACIES AND LIBERALISATIONS

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18. Legislative Decree 541/1992: the beginning of process of deregulation
undercurrent of pharmacy
On 30 December 1992, then, Is laughed the Legislative Decree no. 541 which, in the
context of the activities of information and presentation of medicinal products carried
out by doctors or pharmacists, prohibits (Article 11, point 1) the granting, offering or
promising of prizes, pecuniary benefits or in kind, Except that they are of negligible
value and are nevertheless linked to the activities performed by the physician and the
pharmacist, whereas for medicinal products included in the Therapeutic Formulary The
National Health Service subject to illegal promotions have (Article 15 point 2) that the
irregularity involves the suspension of the medicament from the Formulary itself for a
period of up to two years. This Decree therefore intervenes to further counteract the
phenomenon of the comparisons of medicines that it may affect, as it does not in fact
actually emerge from the chronicle, to an extent that is not so much socio-economic at
the socio-economic level, not just local communities but also the Country system
especially for the economic cost flowing on the National Health System and because it
is a serious danger that can cripple the citizen's relationship not only with the
professional actors involved in the scams, namely doctors, pharmacists, accredited
public and private institutions, but also, at least tangentially, of their respective
corporate and national representation entities. At the same time, however, this Decree is
also the beginning of the underdrawn process of deregulation of the pharmacy as it
defines the medicines that can be publicized to the public: a first step in the
transformation of certain medicines into consumer goods , whose purchase can be
stimulated by advertising.
19. Online pharmacies and privatizing community pharmacies
19.1 In the early 1990s, the first online pharmacies appeared, websites where it is
possible to buy drugs directly via telematics (pharmaceutical e-business) which
are then delivered to the buyer’s home.
19.2 Always in the nineties some municipalities decide the privatization of the
pharmacies they its hold, create joint stock companies for the management of
municipal pharmacies and subsequently proceed to the sale of majority shares of
such companies to multinationals in the intermediate distribution of the drug.
Federfarma harshly criticizes this form of privatization by claiming that it is in this
way likely to overwhelm the primary need to protect the health of citizens in
relation to the interests of strong players operating primarily for commercial
purposes is that, having the ability to control both the intermediate and the final
distribution of the drug, Could be driven to drive the consumption of drugs in their
favor. To prevent this last risk, the law prevents pharmacists who are associates of
companies that run a pharmacy to carry out other activities in the drug business.

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20. Commission Galeotti, competition between pharmacies, outsourcing services
and hospital pharmacy functions
20.1 In 1995 at the Ministry of the Treasury the Galeotti Commission is set up who
makes several proposals for deregulation of Pharmacy: the free sale of medicines
without prescription, the abolition of the organic plant, the remuneration of the
fixed-price pharmacy.
20.2 Also in 1995 there is the beginning of extensive competition between
pharmacies when the association of local pharmacies decides to apply a 10 percent
discount on public prices as indicated by milk and early childhood foods producers.
20.3 In 1996, in Italy, when healthcare establishments started the process of company
transformation, we began to talk about outsourcing the services and functions of
Hospice Pharmacy as a strategic choice aimed at improving the efficiency of the
National Healthcare System and achieving a management economy. The
outsourcing of certain activities should, in fact, allow local healthcare companies to
focus on corporate know-how on enhancing core services by entrusting out-
sourcing complementary services.
In fact, the outsourcing process ends up involving the activities of various health
facilities including the same private pharmacy although not because of a
comparison or internal metabolization to the Category. In the new management
models of the Local Health Company, based on flow expertise, mechanics,
economics, distribution of the drug becomes, in fact, a logistics activity and as such
likely to be transferred to third parties.
21. Onofri Commission and Antitrust Authority
In 1997, again, the Onofri Commission is set up at the Ministry of the Treasury
proposing the release of the pharmacy of the medication without a prescription and the
sale of medicines in pharmacies other than pharmacies in the presence of a pharmacist.
In the same year there were frequent interventions by the Antitrust Authority to
propose the total liberalization of the price of medicines to be paid to citizens, the
elimination of pharmacy monopoly on non-ethical medicines, the overcoming of the
mechanism of the organic plant, the modification of the mechanism Inheritance,
revision of the timetable system, service schedules and vacations, revision of the
prohibition of advertising on prices and services.
22. Pharmaceutical e-commerce and pharmacies in the network
22.1 At the end of December 1997, representing Italy Giacomo Leopardi becomes
President of the Executive Committee of the Pharmaceutical Union of the
European Union (GPUE): the main themes in the agenda are the role of the
pharmacist in the 21st century, the sale of drugs via the internet, the rules on herbal
medicine and dietary supplements.

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In May 1998, under the chairmanship of Italian Giacomo Leopardi, the GPUE
addressed to the European Parliament a worrying communication on the
electronic commerce of drugs.
In fact, the document denies that e-pharmacy violates all Community directives on
electronic commerce of drugs, exposing the health of citizens to serious risks, also
because of the fact that the intervention and counseling are completely elusive
professional of physician and pharmacist.
In addition, the Pharmaceutical Group of European Union and the Standing
Committee of European Doctors, pointing out the planetary dimensions of
pharmaceutical e-business, hope and urge collaboration between the States and the
WHO to reach the solution of the problem by proposing also, as a short-term
intervention, to punish providers who are guilty of hosting online pharmacies.
22.2 At the beginning of 1999, the emergence of pharmacies in the e-network could
be traced as an organized(29)
and significant(30)
phenomenon: the first online
drugstores (www.cvs.com, PlanetRx, Dragstore.com) are open, -pharmacy
strongly supported by bidding
bidders, featuring a vast array of
references and targeted to large
population bands.
Among the strengths of e-
pharmacy there are practicality,
discretion, cost-effectiveness and
assortment, while amongst the
most controversial points are the
violation of privacy with the
inclusion of personal data on the
network, the lack of application
standards of good manufacturing
and preservation and sanctions(31)
;
outlawed websites also allow for
prescription purchase of almost all
drugs(32)
.
According to a report of Incb (International Narcotics Control Board, U.N.
agency) 90 percent of orders arriving at the mailboxes of these sites concern
medicines obtainable only under strict medical prescription. Often these are
dangerous products and capable of creating addiction. Like every store, everyone
has its own style. The Mexican, for example, exhibits a black background with red
writing and sculpted bodies in the gym as well as anonymous plastic vials
containing anabolic and coated spheroids, normally not obtainable without a
prescription: just click on "order" and enter a card number credit! American sites,
on the other hand, are more country style.
There is a picture of a family doctor reassuring in white coats with white hair and
open smile and there are illustrated sites featuring images of sparkling research labs
and other aseptic, simple pills catalogs. If you do not have medical knowledge, the
sites give you help: just click on the disorder and you will see a list of drugs that
you can get home to treat it.

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Some sites only sell to customers residing in a country other than the residency site
for not having to comply with their laws; other sites collect orders and money and
then close and expire or clone credit cards or drugs directly. They do not exist,
objectively, repression tools as the internet makes it all unattainable: the site is
home to, say, Korea or Vietnam, but drugs are dispatched from countries where
certain substances circulate more freely. To block everything would be needed for
planetary Internet regulation or an endless series of bilateral agreements between
the governments of the various States involved.
It is difficult to quantify web pharmacies: from eight thousands according to some
to eleven thousand according to the American Food and Drug Administration FDA,
which has opened a research center on the field in its offices. Recently, the FDA
carried out checks on a thousand of envelopes containing medicines shipped by
web pharmacies: the majority contained counterfeit and dangerous products.
According to a report by the International Narcotics Control Board Incb, 90% of
orders arriving at the mailboxes of these sites relate to medicines obtainable only
under strict medical prescription and often dangerous and capable of inducing
dependence. Investigators and some members of the US and European health
authorities, in turn, call the web pharmacies “dark corner”: the black corner of
the health market(33)
!
22.3 On December 28, 1999, US President Bill Clinton intervened on the e-pharmacy
issue, proposing new and more severe sanctions for illegal online pharmacies:
among its proposed measures are $ 500,000 fines for any violation of the rules,
concession greater powers and resources to the FDA to increase control over the
network, the implementation of public education campaigns on the danger
represented by the purchase of online drugs.
23. Constitutional Court: judgments 27/2003 (hours, shifts and holidays) and
275/2003 (intermediate and final distribution of the drug)

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23.1 On 4 February 2003, the Constitutional Court, with its judgment no. 27/2003
on timetables, turns and holidays considers the Lombardy Regional Law no.
21/2000 fully legitimate whose regulation of timetables, shifts and holidays is
directed “…To assure the right to health, the right of pharmacists (subject to the
limit on social utility) and the efficiency of the public pharmaceutical service…”
(Articles 32, 41 and 97 of the Constitution) and notes that “…The accentuation of
a form of competition between pharmacies based on the extension of closure times
could contribute to the disappearance of smaller exercises and so to alter what is
commonly called the capillary network of pharmacies”. In fact the Court reiterates
that the regulatory system governing the pharmaceutical service is intended to
guarantee constitutional right to health and not protection for the pharmacists; In
this respect, the Court therefore points out that the introduction of uncontrolled
competition in pharmacy systems such as free time may reduce the level of
collateral insured to citizens; The judgment also clearly shows the importance of
ensuring the survival of small pharmacies, particularly at risk, if an uncontrolled
competitive system of the type described above and key elements to ensure the
capillarity of the pharmacy system and the pharmaceutical service.
23.2 July 24, 2003 is filed The important judgment no. 275 of the Constitutional
Court which states that the overlapping of activities in the field of intermediate
and final distribution of the drug, which is determined in case of the sale of
municipal pharmacies to subjects operating in the field of intermediate
distribution, results in a conflict of interests potentially detrimental to the
health of citizens.
Such a decision of the Court in fact determines a change in the requirements
necessary for participation in the contract award for the management of municipal
pharmacies, affecting the outcome of the race itself.
Entering the merit, furthermore, the Court states that incompatibilities for
pharmacists who run a pharmacy in companies (which can not carry out any other

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61
activity in the field of production, intermediate distribution and scientific
information of the drug) also apply to those who run municipal pharmacies:
Therefore, subjects operating in the field of intermediate drug distribution can not
handle municipal pharmacies as the conflict of interest resulting from them could
endanger the health of citizens(34)
. The ruling of the Court also has implications for
similar initiatives promoted by other Municipalities.
24. Ministry of Health: traceability of drugs and the fight against counterfeiting
24.1 Counterfeiting of drugs is a real crime and its gravity is not limited to the
economic damage to a trade mark, a problem that for other types of counterfeiting
is certainly the main one, becomes a public health problem(35)
.
The counterfeiting of medicines also generates an enormous consequence on the
unkind patients: the serious loss of credibility of the whole system and the dismay
at the finding of the existence of criminal phalanxes that do not hesitate to put at
risk of life with deceit and the fraud of suffering and sick men in need of help. No
country in the world can claim to have never known the phenomenon of counterfeit
medicines; In Europe and the United States, despite the tight controls, cases of
counterfeiting are about ten per year with apparent tendency to increase. In some
African states, 60% of drugs were counterfeit (up to 70% of antimalarials), 30% in
Brazil, but it is also alarmed in Europe with 10% of counterfeit medicines.
Also in the United States the
high cost and low public
contribution to pharmaceutical
spending causes increased use of
counterfeit products, often from
Mexico, where it appears that 1/4
of the medicines on the market
are false.
Counterfeiting affects both high-
consumption drugs such as
atorvastatin, sildenafil, tadalafil,
antibiotics and vaccines, as well
as limited-use medications such
as paclitaxel growth hormone or filgrastim. This means that counterfeit medicines
may appear in Pharmacy as in hospital! In particular, 28% of counterfeits affect
antibiotics, 18% steroids and hormones in general, 8% antiallergic, 7%
antimalarias.
No one knows with certainty the size of the phenomenon: gross estimates and often
based on unpublished reports indicate that around 10% of circulating drugs in the
world might be counterfeit medicines: a report of the Center for Drugs of Public
Interest in US says the expected turnover for 2010 is $ 75 billion, up 92% over
2005 to 5 years. This estimate, however, is subject to wide fluctuations in relation
to individual countries: it does not seem realistic to any expert, in fact, such a
seriousness for most European Union countries and, in particular, for Italy.

62
In Italy, however, Carabinieri NAS have seized 1,064,918 packs of counterfeit
medicines in 2005 alone (36)
.
China and India are the major counterfeit pharmaceutical producers but in recent
years even Eastern European countries, Russia and Ukraine in particular, have
become big producers. The traffic would be run by Russian, Chinese, Mexican and
Colombian organized offenses, and it seems that there has been a real and powerful
cartel on the type of drug trafficker.
According to the American Food and Drug Administration FDA, furthermore,
counterfeit medicines exploit ecommerce with over 1,000 online pharmacies.
Although it is counterfeit medicines exclusive of organized crime, it must be
considered that active participation of people with professional experience in the
production and distribution of medicines is necessary. This fact must not lead to
suspect of a whole professional category, but it is necessary to take note with
dismay of the crisis of values pervading the perpetrators of this crime(37)
.
24.2 On July 15, 2004, the Ministry of Health issued a Decree, which was then
published in the Official Journal of 4 January 2005, which lays down rules for
drug traceability through a recognition mark Which allows to verify the
authenticity of the drug and to follow its path from the manufacturer throughout the
country up to pharmacies, local healthcare and hospitals. This measure, in addition
to aiming to exploit the possibility of epidemiological evaluations, is primarily
designed to counter the growing phenomenon of counterfeit medicines, defined by
the World Health Organization WHO “A drug whose labeling has been
fraudulently prepared with misleading information about the content or source of
the product (…) beating so much the brand drugs as well as generic ones and (…)
Containing substances expected, substances other than those expected, no active
substance, insufficient quantities of active substance or may be contained in a
counterfeit packaging”.
24.3 More specifically, there are: perfect fake drugs, identical to the original but
imported through illicit parallel market operations; imperfect fake drugs that
contain the right ingredients but not in the
exact amount (the use of antibiotics
subdivided into various cases induces
phenomena of selection of resistant
bacterial strains) and/or do not meet the
required requirements, for example, in
terms of expiry or bioavailability or
packaging (for example, container material
and sterility standards); apparently fake
drugs (category that is nothing but
harmless: there are many deaths due to
respiratory illnesses in African children
treated with antibiotics without the active
ingredient and in return purchased at a fair price); i Fake criminal drugs that even
contain harmful substances; authentic drugs manipulated such as those that have
been put on the market after new labeling. There is also the high danger

Raimondo Villano
63
associated with poor conservation: a flashy example is the cold chain,
indispensable to preserving the effectiveness of many vaccines.
25. European Commission: Bolkestein Directive on competition in services and
infringement proceedings against Italian Government
In 2004, moreover, the European
Commission, after a thorough reflection
on competition in professional
services, Including pharmacies, invites
professions to eliminate rules deemed
excessively restrictive in favor of other
less “protectionist”. While, conversely,
in the process of the so-called
Bolkestein Services Directive aimed at
fostering competition in the countries of
the Union, the European Parliament
approves the exclusion from the
application of the provision of the health
services sector, including the full service
of the pharmaceutical service: a
substantial legitimacy of the importance
of the presidency of the pharmacy not to
operate in a free market. The European Commission also initiates an infringement
procedure against the Italian Government on inheritance, incompatibility,
proprietary and pharmacy affiliation, essentially asking for capital to be admitted to
the management of pharmacies and that their property may also belong to non-
pharmacists. For its part, the Italian Ministry in response to the Commission does not
accept the allegations claiming that any measure aimed at favoring the prevalence of
mercantile aspects in the pharmaceutical system is detrimental to the health protection
and the quality of the system.
26. Storace Decree 87/2005 on
pharmaceutical discounts
26.1 In May 2005, the Minister of Health
Francesco Storace, at a particularly
difficult economic time for Italian
families, called for a common effort
throughout the drug chain and, in
particular, by Decree no. 87 on
pharmaceutical discounts is charged
with the responsibility of competing
pharmacies by creating tearing
inequalities. Pharmacy, in fact, assumes

64
a new connotation that sees its traditional life disrupted and reaches the shore of the
most popular liberalism: the price of medication, the certainty for the citizen, equal
throughout the national territory, takes the form of any good from Bargain with the
pharmacist.
They are therefore the prerequisites for creating privileged pharmacies (large
pharmacies), who have the option of discounting, against small pharmacies or
family-run or rural ones that have the prospect of a likely closure. Such a form of
liberalism, in the name of the "big fish eating small fish" also poses seriously the
assumptions for the disappearance of the concept of organic plant(38)
.
26.2 Thus, the introduction of the SOP and OTC drugs discount for the first time
shrinks the concept of "drug universality" by removing the dignity of
“existential good” to transform it into “consumer good” and, above all,
abolishing the principle of the uniformity of the cost, in fact, already abrogated
as regards health care, the “devolution” process to the regions. However, the
‘Storace Law’ and, above all, its proper application also appears to some as an
opportunity to render another threat away: the liberalization of the drug
market, far more serious as it would represent if a delegitimization of the role of
territorial pharmacy was very concrete as it came from a wide and varied front.
27. Development and criticality of online pharmacies, task force IMPACT
27.1 During this period, a survey by Comscore, a major monitoring center, reveals that
pharmacy web visitors grow at a rate ranging from 15 to 36 percent per year and
who actually buy medicines in two-thirds of cases does it to save money despite
54% of the sample claiming to be worried about the risks they are facing; the
factors that lead them to ignore these risks are, in fact, the fear and the crisis of the
US healthcare system: In 2002, when rumors of a terrorist attack with the anthrax
spread in the United States, thousands of people crowded in to buy the medicines
needed to defend themselves and something like that occurred in 2005/06 with
avian flu before scientists raised doubts about the efficacy of Tamiflu; the crisis in
the system of American healthcare then leaves 46 million people without assistance
who turn to the web as a plaza where everything is lawful.
The FDA regularly publishes its studies in which it demonstrates that on-line
medications are dangerous, expired, stored inadequately, sold without medical
prescription and counterfeit and exert steady pressure on the US government to
intervene with every means to cut off the traffic.
On the other side, consumer associations are deployed to sites like New-starget.com
and books like Generation Rx: how prescription drugs are altering American
minds, lives and bodies (of Greg Critser, published by Hough-ton Mifflin) who
accuse the FDA of wanting to do, using fear as a dissuasive tool, one “Financial
war against the American people”, A policy of saving Big Pharma’s super profits,
as they are now collectively called the big multinationals of health. Consumer
associations, in their struggles against FDA and Big Pharma, find themselves
alongside even Governors of States and Statutory Audiences of large cities; In

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65
Kentucky, for example, the ability to buy medicines through Canadian sites has
become a matter of electoral debate, while in states such as Maryland, Wisconsin
and Minnesota and major cities such as Boston, authorities have publicly
intervened in favor of e-pharmacies: On the official Wisconsin website there is a
page where Governor Jim Doyle writes “We are here to help the too many citizens
of this state forced to make the unbreakable choice between buying food and buying
medicine”. Help them how? The state helps to buy fairly equitable products in
Canadian web pharmacies controlled and certified by the local government and
only after having submitted a regular prescription(39)
.
27.2 In February 2006, the International Combating Counterfeit Drugs Conference
was held in Rome, promoted and organized by the WHO and the Italian Agency for
Medicinal AIFA(40)
With the support of the International Federation of
Pharmaceutical Industry FIIM and the German Government to identify common
technological, political, legislative, financial and commercial policies and actions to
combat counterfeit medicines(41)
. At that summit, WHO, in addition to supporting
the need to intensify the contrast measures already taken to identify the fake, such
as the bill, colorimetric tests and radiofrequency identification systems capable of
escorting drugs along the distribution chain, and encouraging the elaboration of
more stringent laws(42)
Has baptized the agreement to form the internationally-
named Task-force IMPACT (International Medical Products Anti Counterfeiting
Task-force), constituted by governmental and non-governmental institutions and
charged with developing specific modes of action against the growing
phenomenon(43)
.
28. Pharmacy transformation risks in supermarket and proposed sale of
medicines in supermarkets
28.1 In March 2006, together with his fellow Federfarma studied unformal
hypotheses but outlined in large lines discussed during the assembly of his 110
provincial presidents, and also sent to political leaders on the eve of elections to
understand the path to be taken in the next five years: to clean up Italian
pharmacies from too many cyanfibers for sale on
shelves, which are likely to turn it into a
supermarket, keeping the drug exclusive; To
make the pharmacist a support figure in patient care;
to renounce the possibility of inheriting the
pharmacy of father to son. In fact, President
Federfarma Giorgio Siri himself points out that the
reshaping of the pharmacy in many respects is no
longer dilazionabile.
The Citizens Defense Movement (Mdc) then
argues that pharmacies have become real bazaars
with ‘miraculous’ products for cellulite or slimming,
toys, beauty products, and footwear, and hopes to
soon liberalize drugs from counter to supermarket.

66
28.2 Coop in the same period advances the proposal to bring self-medication in
large distribution to save consumers.
Undersecretary of the Ministry of Health, Cesare Cursi, on the other hand,
expresses his sharp contrast to his Dicastery the sale of medicines in supermarkets,
believing that the drug out of the pharmacy would become a consumer good and
would no longer be a health-care tool. In particular, the On. Cursi argues that the
Ministry opposes any action that tends to reduce health guarantees to citizens as
was also stated in the response to the European Commission requesting Italy to
amend the rules regulating the pharmaceutical service to encourage the entry of
large business operators into the sale of drugs and to allow non-pharmacists to buy
pharmacies. Cursi also adds that rather than breaking the link between pharmacy,
pharmacist and drug, it would be necessary to strengthen the link between
pharmacy and the National Health Service as citizens have a more and more
professional pharmacy and is increasingly close to the needs of the territory and, in
this regard, at the State-Regions Conference has urged The Regions to rapidly
speed up the renewal of the Convention regulating the relationship between
pharmacies and the National Health System so that it is possible to define new
services for citizens: for example, in agreement with doctors of general medicine,
helping home of the elderly or serious ill people identified by the Asl.
Angelo Zanibelli, chairman of Anifa, the association of automation drug
manufacturers, during an interview with entrepreneurs and professions promoted in
Milan by Emanuela Baio Dossi and Enrico Letta, candidates for Margherita
respectively at the Senate and at the Chamber in the Lombardy and Milan Colleges,
invite to “watch over why the drug release request from the pharmacy channel is
not a troy horse for a deeper attack on this system, of which we must rewrite the
rules, but that must be defended for the good of the citizen and the protection of
health”.
29 Incompatibility of the Community legislation of Italian pharmacies: Italy’s
referral to the European Court of Justice
In June 2006, in Brussels, the European
Commission, which in the past has expressed a
strong political position on the Italian
pharmaceutical system, Deals with the
incompatibility of Italian pharmaceutical
legislation with parts of the Community
Treaty concerning freedom of establishment
(Article 43) and free movement of capital
(Article 56) deciding Italy’s referral to the
European Court of Justice as the
interpretation and modification of national laws implemented in April 2006 by the
Constitutional Court did not abolish the conflict with the Community rules.
The two points of the national legislation challenged by the Commission are: 1) the
prohibition on the acquisition of holdings by companies having a distribution activity of

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67
medicinal products (or related to such companies) in private pharmaceutical companies
or in municipal pharmacies. Italian regulation, as interpreted by the Constitutional
Court and as amended by Decree 591/2006 of 26 April 2006 (Article 100 (2)), provides
for the incompatibility between the distribution activity and the retail activity of
pharmaceuticals.
This includes in particular the ban on active companies (or affiliated companies) in the
pharmaceutical distribution to take part in companies operating municipal pharmacies in
the process of the privatization of municipal pharmacies that began in Italy in the 1990s
and which would be compromised by the legal provisions governing these
incompatibilities; 2) the proprietary reserve of private pharmacies for pharmacists only
or for legal persons only consisting of pharmacists. Italian law prohibits natural persons
who do not have a degree in pharmacy or legal persons who are not pharmacists owned
by private pharmacies selling to the public.
The Commission, in fact, believes that “such restrictions may be considered compatible
with the EC Treaty only when justified by general interest objectives, which are
necessary and proportionate to the attainment of those objectives. The Italian
authorities have justified these standards by invoking public health protection
objectives; in particular (regarding the acquisition of shareholdings by distributors) it
is intended to avoid conflicts of interest and (with regard to the ownership reserve) aims
at better control of the people who deliver the medicines to the patients”. According to
the Commission, however, “the disputed restrictions go beyond what is necessary to
achieve the objective of protecting the health. On the one hand, possible risks of
conflicts of interest can be avoided by adopting measures other than the pure and
simple ban - for companies linked to companies active in the pharmaceutical
distribution sector - to take part in pharmacies selling to the public”. In addition, the
official statement reads: “It has been reported to the Commission that there are
numerous cases of distribution or participation in pharmaceutical distribution
companies in Italy by pharmacists holding private pharmacies”. On the other hand,
always according to the official text, “even the ban for those who do not graduate in a
pharmacy or for non-pharmacist legal persons who own a pharmacy goes beyond what
is needed to ensure the protection of public health, as it would be sufficient to require
the presence of a pharmacist to deliver the medicines to the patients and to handle the
stocks. Italian legislation, on the other hand, stipulates that non-pharmacist members of
the family of a deceased pharmacist may be in possession of their pharmacy for periods
up to ten years, acknowledges that the requirement of
professional qualification is not absolutely essential and
priority for the possession of a pharmacy(44)
”.
30. New rules on competition and consumer rights
(Bersani Decree)
On June 30, 2006, among the reactions of amazement,
regret and concern of the Federation of Italian Pharmacists
Orders, the New Law on Competition and Consumers
Rights, also known as the Package Bersani(45)
, document
that is in Title I (Urgent measures for the development,

68
growth and promotion of competition and competitiveness, consumer protection and the
liberalization of productive sectors(46)
Article 5 (urgent interventions in the field of
drug distribution) establishes(47)
:
the sale to the public at drugstores and supermarkets of medicines not subject
to medical prescription during the opening hours of the business, in a part of its
well defined area and distinct from other departments, with the assistance of one or
more pharmacists who are graduates and enrolled in the relevant order and with no
prohibition of competitions, prize-based operations and under-sale sales of
medicines;
the free drug discount: The discount on the price indicated by the manufacturer or
distributor on the packaging of each drug may be freely determined by each retailer
provided that it is clearly and clearly displayed to the consumer and is practiced to
all purchasers; therefore, the maximum 20% discount ceiling introduced by the
previous government is abolished;
the abolition of the obligation for pharmaceutical wholesalers to hold at least
90% of commercial specialties (for medicines not eligible for repayment by Ssn):
with a norm of the decree law it is contemplated, at the same time, the possibility of
the retailer to refuel with another wholesaler;
the possibility that the pharmacist will be the owner of several pharmacies or
associates to handle more exercises and even beyond the provincial territorial
boundary of belonging;
the eliminating the incompatibility between wholesale and retail activities;
the overcoming the hereditary principle by abolishing the legislative proposal
allowing a pharmacist to continue for many years to be a family pharmacy without
having graduated and enrolled in the register.
That package, therefore, contains a set of rules that “appear to be inspired by logic and
interest that with public health does not have much to do with it” because “the
possibility of selling drugs without prescription in supermarkets is likely to open the
door to a mistaken consideration of good drug by citizens” in virtue of the fact that
“Medicinal specialties, including self-medication, are health goods, not consumer
goods, and can not or must have nothing to do with commercial dynamics(48), (49)
”.
Creating commercial chains of pharmacies, in fact, it has inevitably predicated the
prevalence of a merchant dimension, enslaved to the interests of economic groups,
targeted at advertising and marketing and, in any case, far from providing the citizen
with adequate health guarantees and, in any case, far from providing the citizen with
adequate health guarantees. Moreover, the overwhelming commercial concentration
poses a threat to independent pharmacies (especially in small centers) that provide a real
service to the citizen in objectively disadvantaged areas.
For the capillary system of pharmaceutical assistance(50)
, Therefore, there is a real
risk that it will only become a reminder in a few years.
Finally, the possibility of having more than one pharmacy or associating seems to
introduce a genetic mutation of the pharmacist’s figure that as a self-employed
professional becomes an entrepreneur with all that this entails.
The Bersani measure, however, “it is not a lightning strike but a 'politics' that affects
Europe: bad weather never comes suddenly. Much, in fact, was born by the European
Council held in Lisbon in 2000, which approved a treaty, whose ratification is now

Raimondo Villano
69
being questioned, So, among other things, the economy had to become competitive and,
therefore, competition was needed to get lower costs(51)
”. It is obvious, therefore, that in
the drug market, fewer than a business round, only to the oil and to the banking
industry, there are people who are trying to win a share of such a large cake. In Italy,
one of the most active operators in this regard is represented by the Great Distributed
Organization Gdo.
31. Corner of OTC drugs in supermarkets
On August 12, 2006, three Ipercoops in Carpi, Ferrara and Bari open the corner(52)
of
counter medicines, selling corners divided by other departments with ad hoc separation:
they have a green tone background with fluorescent nuances in the benches and the
floor, a plaque indicating that the place is ‘reserved’, a luminous sign that indicates the
health gauge, a sign that explains: “Customer loyalty should not be encouraged with the
indiscriminate consumption of medicines”; the consumers seem to appreciate the
liberalization of counter medicines, which are favorable in eight out of ten(53)
.
Coop alone also plans to open 150 corners by 2007 and 450-500 permanent recruitment
as well as the role of the organization in the distribution of drugs and aims to create a
production hinge in order to reach 50% discount after granting ministerial authorization
to produce drugs with its own brand.
As of August 15, 2006, there is a significant figure that the market for medicines
without a prescription in Coop(54)
even is already 2% of turnover(55)
.
32. Bersani Decree: reaction of pharmacies
32.1 On July 19, 2006, the category adheres tight to the first strike after 37 years:
93% of pharmacies close for protest while Decree Bersani leaves the Budget
Commission; on July 26, between base splits and threats of warning, as well as
Federfarma’s invitations to pharmacies to revoke unsupported drug orders, there is
the second closing “to the extreme limit” of 95% of pharmacists sit-in at Rome
while the Bersani Decree was fired by the Senate with a vote of confidence. The
Bersani Decree is fired by the Senate with a vote of confidence.
The Bersani decree creates a lot of irritation in the category both for the great
media impact of innovation and because the pharmacist always has the profession
within himself and has no cultural propensity to trade.
The pharmacy therefore has a very difficult commercial comparison if it fails to
get the same conditions from suppliers, have a different time from the current one,
take discounts, and offer other services and promotional communications
initiatives.
Politics also tends to reduce the barriers to access to the profession and
increase competition, believing that this will reduce costs and save on public
pharmaceutical spending.
Regarding the pharmaceutical system are being questioned schedules, shifts, leave,
pharmacist remuneration, age limit, shortage of pharmacies in new neighborhoods

70
or rural areas, poor use of decentralization, how pharmacies award through
contests.
All this leads to a need for reform of pharmaceutical regulation or, alternatively,
according to some currents of thought, to a liberalization of the pharmaceutical
service.
In proportion to the corner phenomenon, the consumer is getting used to going to
business without a specific idea of what he wants to buy, and above all, which
brands prefer and impulsively decides, directly, in front of shelves filled with
products(56)
. Likewise, more and more pharmacies adapt to this market trend by
making real internal restyling with remarkable expansion of free-space
exhibitions(57)
that favor self-management of purchases.
32.2 During this period, a company promotes an initiative, promptly opposed by
Federfarma, called Bancomat of medicines, even in the creation of an automatic
dispenser of all drugs (ethical and non) installable wherever it is deemed necessary
and capable of allowing the citizen to withdraw medication and at the same time
interview with a pharmacist via video link. In September 2006, the news spread
that Boots, a company owned by a large pharmacy chain in Great Britain, is
conducting evaluation of employment of general practitioners and hospital
specialists to provide in their pharmacies also other services provided within the
UK National Health Service; naturally this initiative is welcomed by supermarkets
in which a pharmacy operates
33. Clarifications on applied aspects of Bersani Law
On October 5, 2006, the General Directorate of Drugs and Medical Devices of the
Ministry of Health publishes Circular no. 3 of October 3 (OJ No.232) clarification on
the application aspects of the Law Bersani: are allowed to sell the drug outside the
pharmacy the neighborhood exercises (with a sales area of more than 150 sqm if in
municipalities with less than 10,000 inhabitants And 250 square meters in communes
with more than 10,000 inhabitants), the average sales facilities (sales area of more than
150 square meters and up to 1500 square meters in common with less than 10,000
inhabitants and up to 2500 square meters in municipalities with more than 10,000
inhabitants) large sales structures (exercises with an even higher surface area than
previous ones); Medicines sold outside the pharmacy are banking or self-medication
drugs, veterinarians and homeopaths without a prescription, pharmaceuticals placed in
class A with or without a note for which no prescription is required(58)
; the presence of
the pharmacist in the corner must be continued during the opening hours to ensure
personal and direct customer care; the pharmacist may wear the professional badge and
must distinguish himself from any other staff; self-service in the corner is allowed; the
corner sign should be constructed so that it contains names and symbols that “do not
induce the customer to believe that it is a pharmacy”; there is an explicit ban on
incentives to buy drugs through contests, prize-making and low-cost sales; it is free for
every retailer the magnitude of the discount on medicines.
In any case the pharmacy retained its centrality in the relationship with the drug; the
monopoly, therefore, has not been cracked: lifesaving drugs and all those with the

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71
recipe, in fact, remain on sale only in the pharmacy that remains the citizen’s referent of
trust.
The arrival of supermarket products, however, is an enlargement that has a highly
disadvantageous value since, in general, pharmacy only enters when it really needs,
perhaps in an emergency, while the type of commercial sale (prevalent and not
exclusive), education of the Large Distributed Organization, induces in the inventor the
need by leveraging exclusively on the lowering of the price(59)
.
34. Hypermarket and hypopharmacist
It occurs, therefore, in the light of Bersani a historical anomaly: the birth of a kind of
“hypopharmacist” that is the pharmacist of the hypermarket, a practically minusvalent
practitioner who can sell only one category of drugs and not others and has no response
in any nation and never existed in the history of humanity.
In addition, the Great Distributed Organization finds the management of health-
conscious corners even in hypermarkets as it is impossible to pay the hypo-
pharmacist’s salary while cutting out the small and medium-sized exercises with just
banal medication.
The most disturbed limit of the hypopharmacist emerges in the light of the principles of
the Constitutions of Federico II: the economic security of a category does not save from
the corruption and dowry, but the opposite is certain: in the absence of sufficient
income, dishonesty is highly probable; the hypopharmacist in a persistent critical
location of the hypermarket is at risk of quackery for survival needs(60)
.
There is a risk, however, that the decree, though undoubtedly deserving, is conceived as
a first step in replacing of the citizen entrepreneur, of the self-employed worker, of the
independent operator in a market, beyond intentions, “wild”.
Think of the permission of pharmaceutical multinationals to open pharmacies chains (as
opposed to the Constitutional
Court’s ruling) and the
privilege of supermarkets in
administering drugs. It comes,
however, to wonder if it really
is correct and farsighted the
idea that the market is a simple
price decrease, even at the cost
of the destruction of an
entrepreneurial reality (all
Italian heritage), of a possible
abnormal consumption of
goods such as drugs, of a
proprietary attitude that is
confused with competition, but which may be the source of future monopolies or
oligopolies. You notice, in fact, an hostility, in some cases explicit and livelier, towards
small entrepreneurs, artisans and autonomists, who were previously suspected of
evasion and lack of transparency or, at best, considered simple “social dampers”.

72
An irreconcilable concept with those who consider these categories as one of the main
generators of Italian wealth as on other occasions, said the same Minister Bersani. No
one wants to criticize rules that abolish unjustified privileges but it does not seem true,
as some “experts” claim, which liberalizing everything and indiscriminately is good for
the user's citizens and, finally, the problem arises of how to avoid a proliferation of
degenerative phenomena of the profession, which is unfortunately already happening in
our country and widely seen in countries where the free pharmacy market is concerned.
An adequate response, therefore, appears only to be free from an ideological view of
reality(61)
.
That the introduction of new actors in the distribution of medication is in itself an
advantage for the citizen is a theoretical assumption that, in truth, has not found so far
great findings. Beginning, for example, by establishing a real competition. More
properly, a mechanism has been initiated that favors the passage without a hurt from a
“corporation”, as in these times, to an oligopoly whose structure makes it difficult to
continue to support the pharmacy’s social function and cause closure of the less
profitable outlets(62)
. However, large chains tend to rely directly on population trends in
deciding whether to open or close an exercise, so this results in maximum concentration
in the most populated areas, which tend to disappear from community pharmacies. At
the same time, however, the demographic downturn is a push to the closure of
independent pharmacies which can hardly be replaced by large chain exercises(63)
. In
other words, this dynamics could cause difficulties in accessing medication for people
far away from large urban and suburban areas.
On the other hand, too, to keep prices under pressure, in market dynamics, it often
serves to break the forehead and to make the weakest competitors stand out. In fact,
nothing is more opposed to the competition of the market itself, which tends to the
cartel. In fact, when there is only one actor in the square, what are the discounts?
Perhaps it would be worth reconsidering the role of the organic plant also in light of
these considerations. And to ask whether a professional who is dependent on a company
in terms of mere profitability, as it is logical and inevitable, is then motivated to
promote the least expensive drug, or to sacrifice a sale in order to devote itself to the
demands of the citizen.
Some pharmacists, who are victims of the subtle charm of liberalization, require the
Ministry to deregulate working time, benefiting from a prolonged activity in the
afternoon break (by circumventing the rotations governed by regional regulations) by
keeping open mini-wards “do it yourself”, getting a clear rejection.
35. Run the opening of ‘para-pharmacies’ and its effects
But the "Bersani" brand liberalization
siren also makes another slaughter of
hearts (and interests) among
pharmacy owners who, in number, do
not start at the opening of
“drugstores” for the sale of drugs
without prescription, forcing

Raimondo Villano
73
Federfarma's tops to stigmatize such behavior as “politically inappropriate(64)
”.
In particular, President Giorgio Siri and Secretary Franco Caprino of Federfarma
declare the Council of Presidency's absolute opposition to the opening of pharmacy
holders of new drug sales points “to the detriment of the principles of the organic
plant”, the bulwark of the current Territorial pharmaceutical service.
Also, he points on professional pride to prevent the pharmacist from becoming a “mere
drug entrepreneur” and inviting local associations to ensure that para-pharmacy
possibly opened by pharmacists do not become “violation instruments of the sectoral
rules”, considering that: it is forbidden for a licensed pharmacist to engage in activities
in both years (violating the law “always in the pharmacy”); it is forbidden to freely open
subsidiaries or detention centers and, more seriously than possible criminal offenses,
there is a temptation for the pharmacy owner to incur “in collecting recipes for the
benefit and at the request of a pharmacy”.
Furthermore, from the legal point of view, the fate of the pharmacy system is perceived
as a "unity of profession / structure / service" as outlined by the Court of Cassation (4
February 2003, no. 27), while from the metagiuridic point of view it can not be ruled
out the “possibility” that a pharmacy owner can be tempted to either open an
extramanial parapharmacy and to keep the intramanial parapharmacy open when the
pharmacy is closed, By lurking the grotesque when it does not configure (ie!) A mere
act of competition for abusing customers under Article 2598 of the Italian Civil Code
in the face of the ‘pharmacy network’ which guarantee the pharmaceutical service as a
public and social service (Constitutional Court, 27/2003) with temporal and territorial
continuity, Assumed in the concession of the profession exercised for that purpose in an
organized structure of enterprise (Constitutional Court, december 28, 2006, no.)(65)
.
36. Progressive loss of professional dignity
The profession, though, for many years in both the Professional Order and the base, was
more than the sentiment of a widespread desire for liberty and was subjected to a
progressive loss of professional dignity, seems to have come to a sort of last beach to
do a proper reflection and to assume both the awareness of the absolute dependence of
its future on a collective awareness of the unprocrastinability of the rediscovery of
the role of the pharmacist as a sentinel to protect public health is the responsibility of
the behavior that would arise: of course, not ignoring the structural rigidity of the
pharmacy system, unable to adapt to the needs of the community but with an excessive
“elasticity” in the application of the principles inherent in the very concept of
profession.
For a long time now, in the category, a widespread involuntary self-referential process
in the category is convinced that it is enough to have caduceus on the shirts to be
considered indispensable professionals for the community, to deserve the respect of
others, to be sufficient to themselves and not to need others; in doing so, it has been
created around a political and institutional void and at the time of need for help,
although there are no arguments that are objectively compatible, there are indeed few
very few and very few willing to support us.
For some time now, there is not an antidote to the excess of neglect that is among the
serious faults committed “by the pharmacy that, in the shelter of the traditional

74
strengths ensured by the legislation, he was not too concerned about building his future
but was limited to discovering what he was doing, doing nothing but collecting what
arrived. Until the days have begun to bring surprises far from pleasing, beginning with
the collapse of many of those strengths that provided protection(66)
”.
For too long, the profession is characterized by poor cohesion by speaking different
languages, sometimes in contrast, sometimes merely dissonating among themselves,
sometimes asonistic but still different: The impression given is of a unified profession
and, in some circumstances, at least definable and defined (even by ministerial
summaries) “represented badly”.
Not a few people too have moved too far from the violation of the most elementary
deontological standards, and too often they serve for service rendered to the citizen
any more bickering form of unfair competition(67)
.
In recent years, however, an even greater responsibility for the Pharmacists category
appears to fall heavily on some of the store pharmacies, more or less large but with
business rounds beyond every medium and every imagination, which rely solely on the
principles of aggressive trade and which, unfortunately, are often largely devoid of
ethical and moral scruples.
Such abnormal pharmacies, as evidenced by numerous investigative activities, are
capable of establishing compliant or fraudulent collusions, sometimes even with
politicians, creating militant commercial monstrosities that spread a real moral
disorder through the establishment of muddy relationships with complacent physicians
(from the rent of the ambulance, sometimes even in the same pharmacy, much worse:
compliant or false prescriptions and various scams) and / or establishing a closed market
in which holders and politicians barred licenses and prebends.
Obviously, the honest and scrupulous pharmacist who unluckily has close to one of
these pharmacist brats or should stop being such or should go elsewhere to practice
honesty and scruple or, shortened in a short time, is sucked into a spiral where he
comes to try even the pain of honesty.
It should not be forgotten, then, the recent phenomenon, as well as investigative
attention, of malicious infiltration in some companies in order to place their own
protected workers or their family members for internal control and, above all, to make
huge economic profits and recycle dirty money: a real basin of virtually no bottom.
More generally, therefore, the profession inevitably finds itself in different
circumstances to deal with the public need of ‘to wash the errors and not just the
face(68)
’.
37. Importance of the pharmacist in the last thirty years
In short, in the period coinciding with approximately the last thirty years considered, the
importance of the drug has increased considerably (in healthy terms for the development
of new molecules; in economic terms, for the huge increase in public and private
resources allocated; in social terms for growing attention dedicated to the population
and the media to health and well-being). Correlatively, however, did not increase the
importance of the pharmacist. This also because the development of the drug size is not
only the result of the economic weight of public and private pharmaceutical spending:

Raimondo Villano
75
the drug, for example, demonstrating over time its business potential, has attracted
numerous economic interests; Increased expectations for life-saving drugs and major
illnesses, but also for medicines intended for the treatment of minor diseases and
disorders, as well as for performing drugs (eg sports, amateur, etc.). Faced with a role
that has become so invasive in the collective imagination, the role of the pharmacist has
not only grown in the same degree, but in some ways has even declined as because the
customization of the relationship is diminished by the confidence in the brand and by
the gradual expansion of the product, which is not infrequent in the pharmaceutical
exercise, as for the exasperating exasperated commercial and marketing connotation
adopted by an increasingly significant number of pharmacies, as even for a number of
black news events, and because the consumer has been gradually induced to believe and
he has also increasingly believed that he can do without the pharmacist.
Consequently, the current situation, with the liberalization ‘Bersani’, is also the result of
a significant imbalance stratified over time.
Until a while ago it was desirable for a renaissance of the profession: it was necessary to
find, not find.
Tuttavia, adesso appare chiaro di come il futuro sostanzialmente abbia messo
saldamente le radici nel presente.
In any case, in this regard, I had the opportunity illo tempore to express my personal
preference for sharing the Vichian consideration(69)
that there are moments that seem to
be overwhelming and are, instead, opportunities. I am, at the same time, strengthening,
today, as then, the conviction that in the future, even if not remote, I will probably risk a
disappointment only and exclusively not for what I have here but for what is significant
and decisive has not been done.
The great goal, therefore, that at this time seems to inevitably go to profligate for the
Italian Pharmacy is, in fact, a crucial new way of seeing things. The hope I felt and feel
profoundly not to miss about this delicate moment of Profession is that the Category has
the “serenity to accept things that can not change, the courage to change what can
change, the wisdom to distinguish one from the other” and, grasping a jerk of its
unrepeatable past, is capable, paraphrasing Adonis(70)
, of “transforming tomorrow into
prey and chasing it at a loss of breath”.
The determining factors for the archetype of this modern pharmacy are the affirmation
of an ethical identity and of new service and commercial strategies that must always and
in any case have the ability to fully satisfy the needs of contemporary society.
38. Dissemination of navigation for medical purposes on internet
At the end of 2006, there was also a significant spread of internet surfing aimed at
gathering information about their own health and family and relatives or on
prescription drugs.
In Italy alone, for example, the worldwide World Wide Web network is the first source
of health information for over 20 million Internet users: 78% of Italians, 15.6 million
people, have been navigating over the past 12 months to seek medical information on
average for four different diseases(71)
.
These internet users are “mainly in the age range of 25-49 years and with medium-high
schooling. Of these, 75% of them also seek news about self-medication drugs. Among

76
the most painful diseases in the head there are problems related to obesity and weight,
followed by back and headaches, seasonal pathologies and dermatological disorders.
Then they ask for answers on contraception and pregnancy, asthma and allergies and
gastrointestinal problems, but also insomnia, anxiety and depression” while more
serious and complex pathologies, such as “tumors, cardiovascular diseases, eyesight, or
gynecology, are instead clicked not so much for seeking care but as having information
and documentation(72)
”. The web, in any case, appears to the Italians as the main source
of help in seeking medical information: in fact, it is targeted at the network in 66% of
cases (13.5 million people); therefore, much more than doctors (54%) or pharmacists
(53%) or friends or family (34%), books or newspapers (31%), TV (25%), or the radio
(6%). Making the search for online news better is the same kind of medium that “allows
frequent and easy use”. In 72% of cases, information is clicked on a search engine page.
Then go to specific portals (51%), pharmaceutical companies sites (28%) or information
providers (22%). You also browse abroad, as 47% of Italians read non-Italian web
pages. “The most popular and used Italian sites are relatively few generalists. As the
need arises, 80 percent of Internet users can access information contained in sites
focusing on specific topics”. Google is the most used portal, accessed by 93% of Italians
in a year, followed by Yahoo (28%), Libero (21%) e Alice (16%).
In the period 2000/2006, only the Carabinieri for Health Protection Command seizes
seizures of over one million vials containing non-conforming quality drugs and
from non-controlled networks(73)
.
39. Antitrust Authority’s actions on schedules, rosters and restrictions of
competition
On 1 February 2007, the Italian Legislative and Government bodies (Parliament and
Council of Ministers) and the Regions have submitted an institutional but non-binding
Report to the Antitrust Authority for a review of timetables and shifts of
‘pharmaceutical exercises’, of the central point of which is the conviction that “…the
constraints that prevent pharmacists from lending their services beyond these
timetables and shifts seem to restrict competition unjustifiably …”. In particular, the
Autority requires legislative action to: eliminate the maximum hours limit for daily or
weekly opening, extending the pharmacy’s ability to open beyond the minimum hours
required by the legislation; eliminate the minimum annual leave limit; eliminate the
imposition at regional or municipal level of uniformity obligations at opening times; To
avoid, in any case, that decisions made by local authorities are affected by interventions
by the representative bodies of pharmacists. All this by claiming that the legislative
amendment introduced by the Bersani Decree would result in a competitive
disadvantage at the expense of pharmacies forced to adopt opening hours, shifts,
vacations, etc. more constrained than their direct competitors of the Large Distributed
Organization and considering that the ruling of Constitutional Court no. 27 of 4
February 2003 and arguing, on the other hand, that the maximum opening time limits
would paradoxically pose a danger to pharmacies which are no longer capable of
holding competition with commercial undertakings not subject to the same constraints.

Raimondo Villano
77
On May 28, 2007, the Antitrust Authority launched an investigation against
Federfarma Teramo on charges of restrictive competition for showing its associates
the maximum discounts to be made on the sale price to the public of a series of bank
counter without obligation of recipe(74)
.
40. Chamber of Deputies: work on fitness for ownership, staffing plan and ‘c-list’
In May 2007, the Commission X (Productive Activities) of the Chamber of Deputies in
Rome, in the context of the works focused on
Nel maggio 2007 a Roma la Commissione X (Attività produttive) della Camera dei
Deputati, nell’ambito dei lavori concentrati sulle “Measures for the consumer citizen
and to facilitate productive and commercial activities as well as interventions in areas
of national importance”, in the text resulting from the excerpt of articles 28, 29, 30 and
31 of bill 2272 passed by the Shareholders' Meeting on 17 April, endorses the
amendment to the elimination of eligibility requirements for a pharmacy owner(75)
while rejecting two other amendments: the first to lower the quorum of the pharmacy
ratio per inhabitant from one in every 4000 to one per 3000 and regardless of the
population of the commune in question; the second for the possibility of selling in large
distribution and in pharmacy, with the only link to the distance of at least 250 meters
from the nearest pharmacy, even medicines subject to medical prescription of 'C-band'
with the only exception, therefore, of those charged by the National Health Service.
On 29 May 2007, the House approved the amendment of the deputy Sergio D'Elia
(Rosa in punch) (76) contained in the ‘Bersani-bis’ with which it is envisaged to
deregulate (the only case in Europe) the sale of medicines requiring medical
prescription allowing the sale of medications c with prescription requirement even in
pharmacy other than pharmacies.
After approving the House, the Ddl passes to the Senate where the Government intends
to speed up its launch within a few months.
Therefore, at the 2.09 billion euros (2006) of the total market for prescription-free
drugs, the C-class drugs of 3.08 billion for a total potential extra pharmacy market that
would exceed 5 billion (with very good products such as Viagra!).
In addition, it should be noted that the measure was approved “breaks a taboo: the drug
is linked to a person, the pharmacist, not to the shop(77)
” while from the front of the
pharmacist category it denies that “they are destroying pharmacies, a service
appreciated by the community” and that “So they want us to close(78)
”.
41. Reactions to deregulation of sale ‘c-list’ drugs with a medical prescription
41.1 Consequently Federfarma brings the Presidency Board permanently to
constantly analyze and discuss possible protest initiatives aimed at obtaining the
deletion of the amendment while Council members are daily engaged in ongoing
meetings with all the political forces of the entire parliamentary arch “to expose
the adverse consequences of the amendment(79)
”.
President Federfarma Giorgio Siri also convenes an emergency meeting of the
National Assembly, which will be attended by trade union delegates of pharmacy

78
holders throughout Italy, on June 7, 2007, to which Federfarma’s board of
directors resigns as a protest; At the meeting, Siri also invites the President of
the Council of Ministers Romano Prodi, Minister of Health Livia Turco, Minister
for Economic Development Pier Luigi Bersani, as well as majority and opposition
MPs which Federfarma intends to ask for clear answers on the future of the Italian
pharmacy and the level of health protection they want to guarantee to citizens-
voters.
A statement by Federfarma of May 31, then, points out that “it is unworthy of a
civil and democratic country that, just as more than one tables of confrontation
between government and industry are open (to pharmaceutical spending,
pharmaceutical service delivery, and the role of pharmacies), with a handshake of
the majority to the House, an amendment approved, which, if confirmed by the
Senate, would demolish the pharmaceutical service. Pharmacies do not intend to
be helpless at this dripping and are ready to carry out heavy protest initiatives,
until it comes to the switch to indirect pharmaceutical care across the country.
This decision will be necessary if the Government and the Parliament do not have
concrete evidence of the will to open a unique and serious confrontation table, on
all pharmacy issues. The first sign that Federfarma expects is obviously the
deletion of the amendment, approved by the Chamber”.
Siri declares, again, that he intends to request “to the President of the Council the
immediate opening of a meeting table aimed at the suppression of the amendment
by the Senate” and that “in the absence of a table call” will not “to propose to the
Assembly the adoption of drastic initiatives for the protection of the
pharmaceutical service (...) unavoidable in order to understand the senselessness
and the dangers to the health of the citizens of what is provided for in the
amendment”.
Very critical Federfarma declares, again, that “Government and majority carry
forward their plan to dismantle piece by piece Italian drugstore, so far considered
one of the best in Europe, Delivering it into the hands of the chains of Large
Distributed Distributions and Multinationals”.
The Association of Owners also speaks of “Another gift to large Italian business
groups such as Coop, or multinationals such as Auchan and Carrefour, and the
emerging chains of parafarms” performed “while the Ministry of Health is
currently working on a comparison table with industry operators to make the
pharmaceutical service more and more responsive to the needs of citizens”. In the
statement, finally, Federfarma affirms: “The question to which pharmacies ask for
a response is: to those who are willing to sell anti-cancer drugs, antipsychotics,
narcotics, antidepressants, antiepileptics, estrogens, day after pill on supermarket
shelves? Truly, do you think about how to do the interests of citizens? We are
confident that we are the only European country that is heading this way and
allows the sale of medications with a Prescription and of particular relevance in
normal business is a sign of civilization and progress?”.
41.2 On the other hand, the Federation of Pharmacists Orders, reduced by a meeting
with the Ministry of Health, calls for a ponderless reflection on the possibility of
confirming to the Senate the amendment on the sale of non-agreed medicines with
the SSN outside pharmacies highlighting the fact that while not breaking the

Raimondo Villano
79
standard of the principle that these drugs should be dispensed by the pharmacist
behind a regular medical prescription, it is equally true that the pharmacist is a
skilled practitioner wherever he is in the job. Then evaluate further the possible
effects of this liberalization, unique in Europe and in the world, as the drug should
remain healthy and not consumer, the Federation believes that the pharmacy
service can not be distorted by eliminating the exclusivity on the dispensation of
very delicate drugs (for example, narcotics, poison, doping, psychotic, antitumor,
anxiolytics) and often dispensable to the SSN. The service, on the other hand, has
been strengthened in the perspective (also shared by the Minister of Health Livia
Turco) that the pharmacy becomes a multifunctional health center, meeting the
needs of citizens. The hope of the Federation is therefore that it can lead to a
complete revision of the pharmaceutical system without short-term changes that
may create confusion among citizens and health workers.
41.3 Health Minister Livia Turco, again, declares that he will ask the Senate to
correct the House’s decision regarding the approved amendment that allows the
sale of C-band drugs outside pharmacies and expresses “disagreement with the
amendment, submitted by Members of the majority and approved by the House of
Deputies” continues by stating that “the reason for the clear disagreement is
based on precise health considerations. As opposed to self-medication (class C
bis), medicines included in class C mainly belong to very delicate product types
and, therefore, can only be sold after prescription of medical prescription and
sometimes, subject to the occurrence of additional conditions. Leaving the
pharmacy out of the sale of these medicines means not understanding the system
of collateral that is now provided by those exercises: A system that is not
characterized by the presence of a pharmacist alone, but by a dense, proven and
continuous exchange of information between practitioners working in the
pharmacy, The national authorities responsible for the authorization and
supervision of medicines and the regional and local health authorities responsible
for overseeing the same exercises”.
The Minister then points out that in
this group of medicines “Include
oncologic drugs, dopamine drugs,
and others, quite similar, for some
basic technical features, to the A-
band drugs delivered by the SSN.
Only the day-to-day dispensation
structure used to handle one another
and the other, namely the pharmacy,
is able to provide the patient with the information and services essential to the
safe use of products that remain, however, at high risk” and concludes by saying
that the situation that would arise is “The opposite of what we would all hope: a
clear and transparent system based on a clear distinction of roles and
responsibilities to offer the maximum health guarantees to the consumer. That is
why the Minister of Health intends to engage in the Senate’s removal of this
wrong and hasty passage(80)
”.

80
41.4 The Assofarm’s municipal pharmacies then followed with concern how they did
and did not share the approved amendment to the House, hoping for a rejection of
the Senate and reserving “Initiatives to overcome the weakening of the
pharmaceutical service in the country”. Their proposal already communicated to
the Government does not change: “more health services in pharmacy, plurality in
pharmacy property; more municipal pharmacies to be established especially in
areas where service is lacking, particularly in the South of Italy; remuneration of
the pharmacist based on professionalism and quality of service; more flexible
schedules by giving the local authority the opportunity to set such times”.
41.5 For the National Free Pharmacists Movement (MNLF) what counts is the
pharmacist and claims that “Citizens’ health guarantee is not the place where the
drug is delivered, but who carries this action. It is therefore irrelevant to the
protection of public health if the pharmacist operates in a pharmacy or other
exercise” and commented with a note the controversy of the Minister of Health
Livia Turco and the pharmacy holders according to the standard approved by the
Chamber, “Moreover, no one is tempted to question the professionalism of the
doctor depending on whether he or she is the owner of the study where he
exercises. Likewise, the pharmacist is irrelevant for the protection of public health
when working in a pharmacy or other exercise. Only his preparation and
professionalism will be instruments suitable to guarantee the citizen”. According
to the MNLF, the only risk among those subjected to by pharmacy owners is that
“economic, that is to lose that system of protections that to date have guaranteed
their revenue” and hopes that the Turco Minister “Listen less to the ‘vestals’ of the
pharmacy monopoly” and pay more attention “to the demands of modernity that
come from civil society and from that majority of pharmacists to this day hindered
from exercising freely their profession”.
The MNLF, in addition, in the framework of their 3rd National Congress in
Rimini, which also included Sergio D’Elia (Rnp), the MNLF announced that it
was ready to enter the square to defend the amendment approved by the House,
while MNLF President Vincenzo Devito declares that “The Minister of Health
and the Government can not fail to take into account the desire for freedom that
breathes in this room”. The appointment is given in Rome for the start of the
Senate debate and the Movement underlines in a note that will manifest “for
freedom and to give strength to the most advanced component of the government”.
41.6 The Federation of Doctors’ and Dental Practitioners’ Federations,
furthermore, judges negatively the possible release of Pharmacy C drugs from the
pharmacy but asks that the pharmacy does not invade medical expertise. In
particular, the President of the FNOMCeO Amedeo Bianco states that “In this
way, it risks further emptying the role of Pharmacies, which should instead
restore their full function to ensure the provision of pharmaceutical services with
territorial capillary and professional presence”. But the Central Committee of
doctors and dentists clarifies, with respect to the role of pharmacies, all their
thoughts: “At the same time, proposals to transform Pharmacy into a provider of
first-level healthcare facilities (telemedicine services, laboratory examinations,
etc.) - he said in fact White - they risk giving improper professional roles to the

Raimondo Villano
81
pharmacist, creating false citizens in the citizen and exposing the professional to
serious legal liability”. “The availability of a remote telematics report, in fact,
was not over - was found in the Central Committee - from the need for a
comprehensive direct clinical evaluation. And within the National Health Service
Pharmacy, in addition to ensuring the availability of medicines, can play a key
role in providing advice and information to local doctors, pharmacovigilance,
distribution of presidia and aids, support for domiciliarity and integrated support.
The pharmacist is a key figure in health service. We would jeopardize the safety of
citizens if we turned it into an improvised physician or a healthcare provider”.
The FNOMCeO, Therefore, renews its willingness to collaborate with other
professional categories, with the Ministry of Health and the Regions on the
modernization strategies of our National Health Service, guaranteeing citizens the
security of professionals with a specific asset of expertise and experience.
41.7 Senator Laura Bianconi, then head of Forza Italia in the Senate Hygiene and
Health Committee, prepares a counter-amendment to abolish the standard
approved by the Chamber, and is contained in the DDL Bersani. About
liberalizations that extend the sale out Pharmacy drugs of class C Bianconi
expresses his “full opposition to the amendment that extends the sale to normal
commercial shops and the special spaces of class C pharmaceuticals
supermarkets with a prescription requirement” and states that “the sale of these
medicines from the pharmacy means not to understand what value and safety they
now guarantee those exercises, which the State wants to protect the health of the
citizen. Professionals who work in pharmacies for constant updating, provided by
the national authorities responsible for licensing and monitoring drugs, are a real
security for us all”.
41.8 On July 18, 2007, representatives of Federfarma and F.O.F.I., also presenting
parapharmacy organizations, are in audition at the X Senate Industry Commission
and argue the clear opposition to the exit of “class C” drugs from the traditional
channel resulting from the amendment D’Elia introduced in the House with a
rather ruthless attitude, yet capable of holding the scene as a few other topics, but
not surprisingly, because the large distribution, unsatisfied with the OTC and SOP
sales, has heavily insisted on the need to expand the own offer.
41.8 A The arguments put forward by senators from the F.O.F.I. point out: that
in “class C” are very delicate drugs (narcotics, dopants, antipsychotics,
antitumor, anabolic, day after pill) which dispensing within the
pharmaceutical structure guarantees the safety of citizens through a
complex mechanism of controls and vigilance set up by health authorities;
that the abolition of exclusive pharmaceuticals on these medicines, which
account for about 50% of annual turnover and are able to offset
expenditure charges, may lead to a progressive reduction in the capillarity
currently provided on the territory, as well as in timetables night; that if for
pharmacists in rural or peripheral areas became more profitable to open an
exercise in the most commercially desirable areas, those areas would
simply be left out of pharmacies, to all citizens; that there are aspects that
conflict with the organization itself of the pharmaceutical service:
encouraging the opening of parafarms and the corners of large distribution,

82
through prospects of greater profits, means blaming the criteria governing
the organic plant, favoring the proliferation of exercises without distance
constraints; that the effects of this process have been verified in Greece,
where the liberalization of pharmacies was decreed in 1991, but when it
became apparent that the exponential increase in the number of exercises
compromised their economic viability, the government established the
total blockade in 1997 opening new pharmacies: a precedent, which should
also reflect the pharmacists interested in this measure, who, in the medium
and long term, still risk ending up in the chains of large multinational
chains; that even in the case of this proposal for liberalization, as was the
case with last year’s Decreto Bersani, there are some miraculous savings
for consumers while it should be recalled that the “class C” drugs are
subject to fixed and unique prices throughout the country so that their
purchase at a pharmacy or elsewhere does not change economically
anything for the citizen.
41.8 B For its part, Federfarma submits a document, approved on July 17 by the
Presidency, stating that the first consequence of the disruptive measure,
even if deliberately not highlighted with the necessary clarity by its
supporters, of Article 2 of the bill AS 1644 introduced by the House
following the approval of the amendment to sign Sergio D’Elia, allowing
the sale by supermarkets and pharmacies of all medicines requiring
medical prescription when they are not disbursed to SSN (class C), It
would be the institution, outside of any rule, of real pharmacies “not in
agreement” with the National Health System, overlapping the current
pharmacy network. It would be a decisive and irreversible step towards the
wild deregulation of the system and the discarding of rules that
guarantee a capillary presence of pharmacies throughout the country,
From the large metropolitan area to the small rural or mountain village.
For this reason, convinced that health protection should always rely on
certain and shared rules, strongly affirms the willingness to review and
remodel the rules that ensure the operation of the pharmaceutical service in
order to adapt to the needs of the community, in particular with the aim of
verifying and eliminating any deficiencies in the system, both in terms of
the territorial presence of pharmacies and the quality of the service. At the
same time, Federfarma expresses its clear opposition to wild forms of
deregulation of the pharmaceutical service, aimed at destroying a
functioning system, Is appreciated by the citizens and can be further
improved without being overturned and for these reasons asks for the
deletion of Article 2 of the DDL under review and similarly asks for the
suppression of the Article 7 of the DDL which also tends to reduce the
level of collateral against the citizen by abolishing the requirement of
fitness or professional practice for the purchase of pharmacies and the
possibility of setting up mini-chain pharmacies owned by a single
proprietor pharmacist.

102
54
NOTES

104
(1) Circular n. 1900 of October 30, 1846; State Archives of Naples, Regio Protomedicato Fund,
bundle 139, General provisions for annual inspections from 1827 to 1861.
(2) Decree Dec. 27, 1815; Office 21 July 1832 art. VIII; Sovereign Rescripted June 9, 1833;
And art. 15 of the Regulation promulgated by the Real Decree of 10 April 1850.
(3) Protomedical standards of April 7, 1838.
(4) Ibid.
(5) According to the Veleno Gets from 1713 to 1733 and under the protomedical circular no.
404 of July 7, 1841.
(6) Ordination of Pharmacies of the Kingdom of the Two Sicilies of 1850.
(7) Griffini R., “Increases in the study and exercise of the pharmacy” - Crepuscolo, year III n.
28, 11 lug 1852 p. 445-448.
(8) Giudo Verucci, The Catholic Church in Italy from Unity to Today.
(9) Alberto Torresani, History of the Church.
(10) Paolo Mieli, History and Politics. Between State and Church. Rizzoli, June 2001, pp. 157-
163.
(11) Cantoni G., Monastic and conventual pharmacy - Cristianità, n. 270.
(12) Ministry of Health, Website, 2006.
(13) Substantially, in fact, in order spread across the Italian territory, various correlation ratios
to the proportion of pharmacy residents are applied by the past centuries; moreover, during the
nineteenth century in the Kingdom of the Two Sicilies a division of the city into sections was
elaborated by the Protomedical service and in particular the following sections were identified:
Avvocata, Vicaria, Chiaia, Porto, San Ferdinando, San Lorenzo, San Giuseppe, San Carlo
all'Arena, Montecalvario, Pendino, Mercato;
(14) This competence over time is transferred first to the Provincial Doctor and then from the
Region to which the current management is entrusted.

Raimondo Villano
105
(15) “Extraordinary review of the organic pharmacy plant in Milan and the province”,
Pharmaceutical Chemistry Bulletin, Fifteen Pharmacy founded by Pietro Viscardi in 1861 -
Year 88, 15/30 January 1949, numbers 11-12, Società Editoriale Farmaceutica Milano, Istituto
De Angeli Milano, pag. XVIII-XX.
(16) Ibid..
(17) Ibid..
(18) Ibid..
(19) Ibid..
(20) Ibid..
(21) Ibid..
(22) Although formally abolished only in the 1970s.
(23) According to law no. 455 of 10 July 1910 abolished with D.L. Of 1935.
(24) Art. 46, R.D. 1706/38.
(25) T.A.R. Sardegna, 29.10.1982, n. 392.
(26) Il Giornale del Farmacista F.O.F.I., Fourth year, n. 7, 12 April 1989, p. 5.
(27) Verdecchia Giorgio, Presi in una rete i dati del Servizio Sanitario, Il Giornale del
Farmacista F.O.F.I., anno primo, n. 4, 24 maggio 1986.
(28) Consiglio di Stato, Sez. IV, 23.10.1984, n. 217.
(29) Phenomenon preceded by smaller sites predominantly specialized in the sale of large
quantities of few products for market niches such as, for example, for the elderly, for athletes,
etc.
(30) According to a widely-estimate estimate made by the Food and Drug Administration FDA
USA, there are over 1,000 e-business pharmaceutical websites in the year 2000.
(31) Villano Raimondo, Verso la società globale dell’informazione, Cap. I, Analisi settoriale
delle principali applicazioni telematiche, pag 25, 26; Cap. II, Analisi settoriale dei problemi
tecnici di applicazione e/o sviluppo delle tecnologie informatiche, pag. 45, 63, 64; Cap. III,

Pharmaceutical Service Reform in Italy from Unification to 2008

Pharmaceutical Service Reform in Italy from Unification to 2008

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