Status of Bioethics in the Philippines

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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.

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Status of Bioethics in the Philippines

  1. 1. Status of bioethics in the PhilippinesCaezar Angelito E. ArceoWorkshop ParticipantFirst International Workshop on Bioethics and Ethical Aspects of BiosafetyNational Centre of Genetic Engineering and BiotechnologyTehran, Iran22 November 2011
  2. 2. Special notesThis speaker:(1) does not represent the Philippine government nor any of itsinstrumentalities, nor is authorized to discuss any matter for the Philippinegovernment or any of its instrumentalities, but participates in this workshopas a mere practitioner in his field. Therefore, opinions expressed in thispresentation are merely of his own as a private practitioner and an ordinaryFilipino citizen and should not be interpreted as opinions from a Philippineauthority.(2) thanks the organizers of this workshop for the opportunity to learn fromIranian and others’ experiences, and to be exposed to and enjoy the culture ofIranians and the Islamic people in general.(3) thanks his co-participants for the camaraderie and sincere friendship, andlooks forward to seeing everyone again in the future.
  3. 3. My profileEducation: BSc Agriculture; Master in Public AdministrationResearch 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 columnsince 1997): GMOs, bioprospecting, patenting, others
  4. 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. 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. 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. 7. Constitutional rightsGuaranteed by the Constitution Article:Right to health Article II, Section 16Right to healthful ecology Article II, Section 16Priority to science Article II, Section 17Role of private sector Article II, Section 20Rural development Article II, Section 21 Article XII, Section 5Right of indigenous peoples and Article XII, Section 5communitiesRight to information Article II, Section 28Local autonomy Article 10, Section 2Right to participation Article XIII, Section 16Science and technology Article XIV, Sections 10 and 12Consumer protection Article XVI, Section 9
  8. 8. Bioethics in medicine/healthLaws TitleRepublic Act 5527 The Philippine Medical Technology Act of 1969Republic Act 4688 The Clinical Laboratory Law of 1966Republic Act 8981 Professional Regulation Commission Modernization Act of 2000Republic Act 7719 National Blood Service Act of 1994Republic Act 1517 Blood Banking LawRepublic Act 8504 HIV LawAdministrative Order 55 Rules and Regulations Governing the Accreditation of Laboratories Performing HIV TestingRepublic Act 9165 Comprehensive Dangerous Drug Act of 2002Republic Act 9173 Philippine Nursing Act of 2002Republic Act 7722 Higher Education Act of 1994CHED Memo Order 14 Policies, Standards and Guidelines for Medicals. 2006 Technology/Medical Laboratory Science Education
  9. 9. Bioethics in medicine/healthLaws TitleCode of Ethics Code of Ethics of the Philippine Medical Technology professionals Code of Ethics of IAMLT Code of Ethics for Registered NursesOther laws and Administrative orders and other issuances related to medicalregulations 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. 10. Bioethics in medicine/health
  11. 11. Bioethics in medicine/health
  12. 12. Bioethics/biosafety in agriculture and environmentLaws TitlePresidential Decree 1967 Philippine Water Code 1976Republic Act 9275 Philippine Clean Water Act of 2004Executive 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 theAdministrative 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 ActRepublic Act 9711 Strengthening and Rationalizing the Regulatory Capacity of the Bureau of Foods and DrugsOngoing GMO Labeling Law
  13. 13. Bioethics/biosafety in agriculture and environment
  14. 14. Bioethics/biosafety in agriculture and environmentComposition of the NationalCommittee on Biosafety of thePhilippines:Chair: Secretary of Science andTechnologyMembers:[1-6] Secretaries of Agriculture,Health, Environment and NaturalResources, Foreign Affairs, Tradeand Industry, and LocalGovernments;[7-11] Practicing scientists onbiological, environmental, health,physical and social sciences[12-14] Representatives from theconsumers, community andindustry
  15. 15. Bioethics/biosafety in agriculture and environment
  16. 16. Bioethics and intellectual property rightsIntellectual property rights (IPR) – anything that is a creation of the mind, whichis 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. 17. Bioethics and intellectual property rightsIntellectual property rights (IPR) – anything that is a creation of the mind, whichis 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. 18. Bioethics and intellectual property rightsProvisions of the Intellectual Property Code:Sec. 21. Patentable Inventions. - Any technical solution of a problem in any field of humanactivity which is new, involves an inventive step and is industrially applicable shall bepatentable. It may be, or may relate to, a product, or process, or an improvement of any ofthe 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 anddiagnostic methods practiced on the human or animal body. This provision shall not apply toproducts and composition for use in any of these methods; 22.4. Plant varieties or animal breeds or essentially biological process for the productionof plants or animals. This provision shall not apply to micro-organisms and non-biologicaland microbiological processes. xxx 22.6. Anything which is contrary to public order or morality. (Sec. 8, R. A. No. 165a)
  19. 19. Bioethics and intellectual property rightsProvisions 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. TheOffice shall acknowledge and put such observations and comment in the file of theapplication to which it relates.Sec. 61. Cancellation of Patents. - 61.1. Any interested person may, upon payment of the required fee, petition to cancel thepatent 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 andcomplete 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. 20. Bioethics and intellectual property rightsProvisions of the Plant Variety Protection Act:Sec. 41. Manner of Developing Essentially Derived Varieties. - It shall also be understoodthat essentially derived varieties may be obtained through processes which may include, butnot limited to, the selection of a natural or induced mutant, or of a somoclonal variant, theselection of a variant individual from plants of initial variety, backcrossing or transformationby genetic engineering. Genetic engineering shall be understood as the introductionof genes by laboratory techniques.(Emphasis included.)
  21. 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. 22. Case 1: Food regulatory systemExample 1: Commercialization of a biological material
  23. 23. Case 1: Food regulatory systemExample 2: Meat production/processing flowchart in the Philippines
  24. 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.phA capacity-building training workshop
  25. 25. Case 2: GMO trials
  26. 26. Case 3: The Philippine Reproductive Health BillContents 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. 27. Case 3: The Philippine Reproductive Health BillCriticisms “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 thecitizens against dangerous substances(Art. XVI, Sec.9) and protect women intheir 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. 28. Case 3: The Philippine Reproductive Health BillCriticisms “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 todecide what is best for their patients.
  29. 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. 30. (1) Philippines can be considered for collaborations.Note: The Philippines has the first biotechnology regulatory system in the ASEAN region.
  31. 31. (2) Presentor would like to hear other countries’ experiencesStatements (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. 32. (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.
  33. 33. Thank you very much!!!Caezar Angelito E. ArceoPhilippinesRegistered 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 Email: info@sapalovelez.com; ca@sapalovelez.com Youtube: http://www.youtube.com/cangear Phone: +63-891-1316 to 19 Twitter: http://www.twitter.com/cangear Website: http://www.sapalovelez.com

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