status of bioethics in the philippines

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

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 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.

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 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

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 Philippines2.1 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

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 12Article II, Section 12

….the State has a duty to protect the

citizens against dangerous substances

Art. XVI, Sec.9

“Every citizen has the right to health.”

Art. II, Sec.15

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 5Article XII, Section 5

Right of indigenous peoples and

communities

Article XII, Section 5

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

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 LawRepublic 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

s. 2006

Policies, Standards and Guidelines for Medical

Technology/Medical Laboratory Science Education


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

regulations

Administrative orders and other issuances related to medical

technology internship trainingregulations 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)

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 Administrative Order 8

Rules and regulations for the importation and release into the environment of plants and plant products derived from the use ofmodern biotechnology (2002)

Executive Order 514 Establishing the National Biosafety Framework (NBF), Prescribing Guidelines for its Implementation, Strengthening the National 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


Composition of the National

Committee on Biosafety of the Philippines:

Chair: Secretary of Science and

Technology

Members:

[1-6] Secretaries of Agriculture, [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

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(2) Utility models

(3) Industrial designs

(4) Trademarks

(5) Copyrights

(6) Related rights

(7) Plant variety protection


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 (2) Utility models

(3) Industrial designs

(4) Trademarks

(5) Copyrights

(6) Related rights

(7) Plant variety protection

Of utmost

importance to

bioethics!!!


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

Provisions of the Intellectual Property Code:

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)


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. -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.


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.)

Outline











Case 1: Food regulatory system

Example 1: Commercialization of a biological material

Case 1: Food regulatory system

Example 2: Meat production/processing flowchart in the Philippines

Case 2: GMO trials

PRSV-resistant papaya confined test site, Institute of Plant Breeding, Laguna

Bt corn contained facility, UP-Mindanao

A capacity-building training workshop

Source:

http://www/ncbp.dost.gov.ph

Case 2: GMO trials

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

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

“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

Criticisms


“…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.

Outline











(1) Philippines can be considered for collaborations.

Note: The Philippines has the first biotechnology regulatory system in the ASEAN region.

(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

(3) Visit the Philippines!

Banaue Rice Terraceshttp://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.

Thank you very much!!!

Caezar Angelito E. Arceo

Philippines

Registered Patent Agent in the Philippines

Work contact:

Sapalo Velez Bundang & Bulilan Law Offices

6776 Ayala Avenue, Makati City, Philippines

Email: [email protected]; [email protected]

Phone: +63-891-1316 to 19

Website: http://www.sapalovelez.com

Personal contact:

Mobile: +63-916-550-6868

Email: [email protected]

Facebook: http://www.facebook.com/cangear

Youtube: http://www.youtube.com/cangear

Twitter: http://www.twitter.com/cangear

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