This is a presentation during the First International Workshop on Bioethics and Ethical Aspects of Biosafety sponsored by the National Centre of Genetic Engineering and Biotechnology, Tehran, Iran, 22 November 2011. This is an attempt of the author to specialize further on intellectual property rights, specifically on the intertwine of patents and bioethics. Since the author is an agricultural researcher in the past and currently a practicing patent agent, this piece is considered as one of his most interesting works so far.

1. Status of bioethics in the Philippines
Caezar Angelito E. Arceo
Workshop Participant
First International Workshop on Bioethics and Ethical Aspects of Biosafety
National Centre of Genetic Engineering and Biotechnology
Tehran, Iran
22 November 2011

2. Special notes
This speaker:
(1) does not represent the Philippine government nor any of its
instrumentalities, nor is authorized to discuss any matter for the Philippine
government or any of its instrumentalities, but participates in this workshop
as a mere practitioner in his field. Therefore, opinions expressed in this
presentation are merely of his own as a private practitioner and an ordinary
Filipino citizen and should not be interpreted as opinions from a Philippine
authority.
(2) thanks the organizers of this workshop for the opportunity to learn from
Iranian and others’ experiences, and to be exposed to and enjoy the culture of
Iranians and the Islamic people in general.
(3) thanks his co-participants for the camaraderie and sincere friendship, and
looks forward to seeing everyone again in the future.

3. My profile
Education: BSc Agriculture; Master in Public Administration
Research background (publications, awards):
Agriculture: Rice heterosis breeding, hybrid rice adaptation;
gene discovery (A. thaliana roots)
Policy: Intellectual property rights, agricultural biotechnology (models
and frameworks, public awareness, etc); local economic
development (commissioned by a prestigious university in the
Philippines which was funded by a UN agency)
Bioethics and biosafety publications (newspaper-based agricultural column
since 1997):
GMOs, bioprospecting, patenting, others

4. Outline
(1) Brief legal background and practice:
1.1 Constitutional rights
1.2 Bioethics in medicine/health
1.3 Bioethics/biosafety in agriculture and environment
1.4 Bioethics and intellectual property rights
(2) Some interesting cases
2.1 Case 1: Meat production and processing in the Philippines
2.2 Case 2: GMO trials
2.3 Case 3: The Philippine Reproductive Health bill(s)
(3) Some recommendations

5. Outline
(1) Brief legal background and practice:
1.1 Constitutional rights
1.2 Bioethics in medicine/health
1.3 Bioethics/biosafety in agriculture and environment
1.4 Bioethics and intellectual property rights
(2) Some interesting cases
2.1 Case 1: Meat production and processing in the Philippines
2.2 Case 2: GMO trials
2.3 Case 3: The Philippine Reproductive Health bill(s)
(3) Some recommendations

6. Constitutional rights
"The State recognizes the sanctity of family life and
: shall protect and strengthen the family as a basic autonomous
social institution. It shall equally protect the life of the mother
and the life of the unborn from conception. The natural and
primary right and duty of parents in the rearing of the youth for
civic efficiency and the development of moral character shall
receive the support of the Government.“
Article II, Section 12
“Every citizen has the right to health.”
Art. II, Sec.15
….the State has a duty to protect the
citizens against dangerous substances
Art. XVI, Sec.9

7. Constitutional rights
Guaranteed by the Constitution Article
:
Right to health Article II, Section 16
Right to healthful ecology Article II, Section 16
Priority to science Article II, Section 17
Role of private sector Article II, Section 20
Rural development Article II, Section 21
Article XII, Section 5
Right of indigenous peoples and Article XII, Section 5
communities
Right to information Article II, Section 28
Local autonomy Article 10, Section 2
Right to participation Article XIII, Section 16
Science and technology Article XIV, Sections 10 and 12
Consumer protection Article XVI, Section 9

8. Bioethics in medicine/health
Laws Title
Republic Act 5527 The Philippine Medical Technology Act of 1969
Republic Act 4688 The Clinical Laboratory Law of 1966
Republic Act 8981 Professional Regulation Commission Modernization Act of
2000
Republic Act 7719 National Blood Service Act of 1994
Republic Act 1517 Blood Banking Law
Republic Act 8504 HIV Law
Administrative Order 55 Rules and Regulations Governing the Accreditation of
Laboratories Performing HIV Testing
Republic Act 9165 Comprehensive Dangerous Drug Act of 2002
Republic Act 9173 Philippine Nursing Act of 2002
Republic Act 7722 Higher Education Act of 1994
CHED Memo Order 14 Policies, Standards and Guidelines for Medical
s. 2006 Technology/Medical Laboratory Science Education

9. Bioethics in medicine/health
Laws Title
Code of Ethics Code of Ethics of the Philippine Medical Technology
professionals
Code of Ethics of IAMLT
Code of Ethics for Registered Nurses
Other laws and Administrative orders and other issuances related to medical
regulations technology internship training
Administrative order and other issuances related to water
testing laboratories
Newborn Screening Act of 2004 (Republic Act 9288)
Organ Donation Act of 1991 (Republic Act 7170)
Intellectual Property Code of the Philippines (Republic Act
8293)

10. Bioethics in medicine/health

11. Bioethics in medicine/health

12. Bioethics/biosafety in agriculture and environment
Laws Title
Presidential Decree 1967 Philippine Water Code 1976
Republic Act 9275 Philippine Clean Water Act of 2004
Executive Order 430 Creation of the National Committee on Biosafety of the Philippines
(1990)
Department of Agriculture Rules and regulations for the importation and release into the
Administrative Order 8 environment of plants and plant products derived from the use of
modern biotechnology (2002)
Executive Order 514 Establishing the National Biosafety Framework (NBF), Prescribing
Guidelines for its Implementation, Strengthening the National
Committee on Biosafety of the Philippines and for Other Purposes
(2006)
Executive Order 247 Bioprospecting (1995)
Republic Act 8293 Intellectual Property Code of the Philippines (1997)
Republic Act 9168 Plant Variety Protection Act (2002)
Presidential Decree 1151 Philippine Environmental Policy (1977)
Republic Act 9147 Wildlife Resources Conservation and Protection Act
Republic Act 9711 Strengthening and Rationalizing the Regulatory Capacity of the
Bureau of Foods and Drugs
Ongoing GMO Labeling Law

13. Bioethics/biosafety in agriculture and environment

14. Bioethics/biosafety in agriculture and environment
Composition of the National
Committee on Biosafety of the
Philippines:
Chair: Secretary of Science and
Technology
Members:
[1-6] Secretaries of Agriculture,
Health, Environment and Natural
Resources, Foreign Affairs, Trade
and Industry, and Local
Governments;
[7-11] Practicing scientists on
biological, environmental, health,
physical and social sciences
[12-14] Representatives from the
consumers, community and
industry

15. Bioethics/biosafety in agriculture and environment

16. Bioethics and intellectual property rights
Intellectual property rights (IPR) – anything that is a creation of the mind, which
is novel at the time of conception.
It provides monopoly to the rights holder.
Kinds of IPR:
(1) Patents
(2) Utility models
(3) Industrial designs
(4) Trademarks
(5) Copyrights
(6) Related rights
(7) Plant variety protection

17. Bioethics and intellectual property rights
Intellectual property rights (IPR) – anything that is a creation of the mind, which
is novel at the time of conception.
It provides monopoly to the rights holder.
Kinds of IPR:
(1) Patents
(2) Utility models Of utmost
(3) Industrial designs
(4) Trademarks
(5) Copyrights
importance to
(6) Related rights
(7) Plant variety protection bioethics!!!

18. Bioethics and intellectual property rights
Provisions of the Intellectual Property Code:
Sec. 21. Patentable Inventions. - Any technical solution of a problem in any field of human
activity which is new, involves an inventive step and is industrially applicable shall be
patentable. It may be, or may relate to, a product, or process, or an improvement of any of
the foregoing. (Sec. 7, R. A. No. 165a)
Sec. 22. Non-Patentable Inventions. - The following shall be excluded from patent protection:
xxx
22.3 Methods for treatment of the human or animal body by surgery or therapy and
diagnostic methods practiced on the human or animal body. This provision shall not apply to
products and composition for use in any of these methods;
22.4. Plant varieties or animal breeds or essentially biological process for the production
of plants or animals. This provision shall not apply to micro-organisms and non-biological
and microbiological processes.
xxx
22.6. Anything which is contrary to public order or morality. (Sec. 8, R. A. No. 165a)

19. Bioethics and intellectual property rights
Provisions of the Intellectual Property Code:
Sec. 47. Observation by Third Parties. - Following the publication of the patent application,
any person may present observations in writing concerning the patentability of the invention.
Such observations shall be communicated to the applicant who may comment on them. The
Office shall acknowledge and put such observations and comment in the file of the
application to which it relates.
Sec. 61. Cancellation of Patents. -
61.1. Any interested person may, upon payment of the required fee, petition to cancel the
patent or any claim thereof, or parts of the claim, on any of the following grounds:
(a) That what is claimed as the invention is not new or patentable;
(b) That the patent does not disclose the invention in a manner sufficiently clear and
complete for it to be carried out by any person skilled in the art; or
(c) That the patent is contrary to public order or morality.

20. Bioethics and intellectual property rights
Provisions of the Plant Variety Protection Act:
Sec. 41. Manner of Developing Essentially Derived Varieties. - It shall also be understood
that essentially derived varieties may be obtained through processes which may include, but
not limited to, the selection of a natural or induced mutant, or of a somoclonal variant, the
selection of a variant individual from plants of initial variety, backcrossing or transformation
by genetic engineering. Genetic engineering shall be understood as the introduction
of genes by laboratory techniques.
(Emphasis included.)

21. Outline
(1) Brief legal background and practice:
1.1 Constitutional rights
1.2 Bioethics in medicine/health
1.3 Bioethics/biosafety in agriculture and environment
1.4 Bioethics and intellectual property rights
(2) Some interesting cases
2.1 Case 1: Meat production and processing in the Philippines
2.2 Case 2: GMO trials
2.3 Case 3: The Philippine Reproductive Health bill(s)
(3) Some recommendations

22. Case 1: Food regulatory system
Example 1: Commercialization of a biological material

23. Case 1: Food regulatory system
Example 2: Meat production/processing flowchart in the Philippines

24. Case 2: GMO trials
PRSV-resistant papaya confined test
site, Institute of Plant Breeding, Laguna
Bt corn contained facility, UP-Mindanao
Source:
http://www/ncbp.dost.gov.ph
A capacity-building training workshop

25. Case 2: GMO trials

26. Case 3: The Philippine Reproductive Health Bill
Contents of the bill
(1) Contraceptives as essential medicines
(2) Mandatory age-appropriate reproductive health education
(3) Additional duty of Family Planning Office
(4) Certificate of compliance before marriage license is given
(5) Ideal family size

27. Case 3: The Philippine Reproductive Health Bill
Criticisms
“Spouses have a basic, original, intrinsic and inviolable
right "to found a family in accordance with their religious
convictions and the demands of responsible parenthood"
(Phil. Constitution, Art. XV, Sec. 3 [1]).
….the State has a duty to protect the
citizens against dangerous substances
(Art. XVI, Sec.9) and protect women in
their maternal function (Art. XIII,Sec. 14).
(1) Population is not an obstacle to development.
(2) The government should focus more on creating jobs and
strengthening education.
(3) A growing concern: our fertility rate is progressively
decreasing.
(4) The government should channel its limited resources to
address the leading causes of death.
(5) Condoms are not a wise investment.
(6) Oral contraceptive pills are dangerous to women’s health.
- University of the Philippines

28. Case 3: The Philippine Reproductive Health Bill
Criticisms
“There is no other qualified authority to propel the discussion on “when
life begins” other than the human embryologist and/or geneticist.”
STAND ON THE SO-CALLED “PRE-EMBRYO” STAGE
“…supports the scientific data that a new cell, the zygote,
comes into existence at the “moment” of sperm-egg
fusion, an event that occurs in less than a second.”
OTHERS:
… government to set up a national emergency obstetrical and child care
… abhors the employment or promotion of contraceptive devices
…shuns mandatory imposition of family size
… rights of physicians must be given utmost respect [and] must be left undisturbed to
decide what is best for their patients.

29. Outline
(1) Brief legal background and practice:
1.1 Constitutional rights
1.2 Bioethics in medicine/health
1.3 Bioethics/biosafety in agriculture and environment
1.4 Bioethics and intellectual property rights
(2) Some interesting cases
2.1 Case 1: Meat production and processing in the Philippines
2.2 Case 2: GMO trials
2.3 Case 3: The Philippine Reproductive Health bill(s)
(3) Some recommendations

30. (1) Philippines can be considered for collaborations.
Note: The Philippines has the first biotechnology regulatory system in the ASEAN region.

31. (2) Presentor would like to hear other countries’ experiences
Statements (i.e., 2-5 minutes each) about:
(1) Presence of laws in bioethics and biosafety in their respective countries
(2) Presence of national and institutional frameworks on bioethics and biosafety
(3) Experiences in implementing bioethics and/or biosafety regulations

32. (3) Visit the Philippines!
Banaue Rice Terraces
http://www.flickr.com/photos/andrecawagas/588948141/
Palawan
http://www.palawan.gov.ph/
Note: This slide was slightly modified
from the original presentation to properly
acknowledge the copyright owners.

33. Thank you very much!!!
Caezar Angelito E. Arceo
Philippines
Registered Patent Agent in the Philippines Personal contact:
Work contact: Mobile: +63-916-550-6868
Sapalo Velez Bundang & Bulilan Law Offices Email: cangear@yahoo.com
6776 Ayala Avenue, Makati City, Philippines Facebook: http://www.facebook.com/cangear
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