UP Manila Chancellor Carmencita Padilla was the focal person and facilitator of a policy forum on counterfeit and substandard medicines conducted by the National Academy of Science and Technology (NAST) in partnership with the Food and Drug Administration (FDA) on January 30, 2020.
The event was attended by representatives from the government, academe, hospitals, NGOs, professional organizations and private institutions. As stated by Chancellor Padilla, the objectives of the forum were to review the global burden and the Philippine burden of falsifying substandard medical products and the policy efforts of the government in safeguarding public health and safety; hear the perspectives from the academe, industry, and other stakeholders; and identify their roles.
Health Undersecretary and Food and Drug Administration OIC Dr. Rolando Enrique Domingo stated that the forum is a good venue to raise awareness on the existence of such products and their risks to the health of Filipinos. He emphasized that the FDA’s mandate is to ensure the safety, efficacy and quality of health products and that the agency is continuously taking measures to enforce the law and penalize violators through the Republic Act No. 8203.
Dr. Soccoro Escalante, Regional Coordinator for Essential Medicines and Health Technologies of the World Health Organization, explained the reformatted definitions of the WHO in terms of counterfeit medical products. A substandard product means that this product is out of the specification that is in the national or international pharmacopoeia. These are authorized medical products that fail to meet either their quality standards or their specifications. This could be caused by manufacturing error or expired or degraded medicines in the supply chain. Falsified products are medical products that are deliberately and fraudulently misrepresented in terms of their identity, composition, or source. Unregistered and unlicensed products are medical products that have not undergone evaluation and/ or approval by the national medicines regulatory authority for marketing.
She stated that based on a WHO study, an analysis of 48,000 samples collected across the world through 88 countries indicated that 10.5% of all the samples had failed the quality specifications of medicines and around 64.5% of the samples of falsified products were antimicrobial.
Recognizing the need to determine the driving forces of substandard and falsified medicines, WHO has identified that constraints in access to medicine is an important driver. She asserted that WHO is trying to initiate a global political will in order to translate the global burden to local impact. She pointed out the need for sound investment strategies: investment in strengthening regulatory capacity and system as a key step to safeguard the manufacture distribution and supply of medical products and cooperation and coordination within the country and across the countries for reporting systems greater transparency and effective multi-stakeholder engagements.
Other speakers and topics were Mr. Ramonito Tampos, President and Chairman of the Board, Merck Business Solutions, Anti-Counterfeiting Technologies of Merck; Dr. Yolanda Robles, former dean and professor, UP College of Pharmacy, Role of Academe; Atty. Katherine Austria-Lock, OIC Center for Drug Regulation and Research-Food and Drug Administration, Counterfeit Drug Product Monitoring; Atty. Emilio Polig, OIC FDA Field Regulatory Operations, Enforcement- How Successful Are We?; and Atty. Bu Castro, Philippine Hospital Association Past President and current Treasurer, Dr. Theodoro Padilla, Executive Director, Pharmaceutical and Health Care Association of the Philippines; and Dr. Oscar Tiño, Chairman, Commision on Legislation, Roles of Various Stakeholders.
