OBJECTIVES

This study aimed to identify problems and highlight opportunities for pharmaceutical sciences research in the Philippine pharmaceutical industry's regulatory and clinical research sectors that might have been previously overlooked or underrepresented. It identified current issues that can be addressed by research covering four areas of pharmaceutical sciences: drug design and discovery, pharmacokinetic/pharmacodynamic studies, formulation design and pharmaceutical technology, and regulatory science.

METHODS

A descriptive qualitative approach was used in this study. Data collection was facilitated by key informant interviews (KII) using a standardized interview guide with open-ended questions to identify the pharmaceutical science research needs of the specific sectors. A purposive sampling method was employed, with five key informants (KIs), including the company vice president, director, and top-level managers from different local and multinational pharmaceutical companies. ATLAS.ti software was utilized to facilitate thematic synthesis for qualitative data analysis.

RESULTS

Thirteen common themes were identified from the KIs, such as (1) incomplete development of therapeutic compounds, (2) sustainability of raw materials supply, (3) regulation of herbal medicines versus food supplements, (4) mapping disease priorities through the Philippine pharmaceutical roadmap, (5) government incentives and policies to support research, (6) technical personnel, (7) suboptimal regulatory process, approvals, and implementation, (8) gap in utilization of acquired knowledge on regulations, (9) regulatory governance, (10) passive regulatory action on counterfeit drugs, (11) PIC/S GMP version 14 adaption, (12) formulation optimization, and (13) active pharmaceutical ingredient (API) sourcing and regulation. Based on insights from the International Pharmaceutical Federation regarding anticipated hurdles in pharmaceutical sciences over the next 5-10 years, priority research needs were identified through KIs' input. Relevant action plans were developed, including the creation of research proposals to isolate, purify, and determine chemical structures of natural products, as well as analyzing recent Philippine Health Statistics to help assess the appropriateness of new drug releases for patient needs. Other action plans include forecasting future disease burdens in the country, performing toxicology studies (Health-Based Evaluation Levels/No Observed Adverse Effect Level or HBEL/NOAEL) for common generic drugs, and ensuring that research efforts are directed toward addressing the Philippine pharmaceutical regulatory and clinical research sector's most pressing needs practically and feasibly.

CONCLUSION

This study offers valuable insights into pharmaceutical sciences research and development initiatives within the regulatory and clinical research sectors in the Philippine pharmaceutical industry. These findings have the potential to catalyze transformative advancements in healthcare delivery and outcomes, positioning the Philippines for global excellence and competitiveness.

Occupational Groups ; No-observed-adverse-effect Level ; Social Control, Formal ; Patients ; Pharmaceutical Preparations

BACKGROUND

The existence of counterfeit medicines has been a long-standing global public health concern. In the Philippines, Republic Act No. 8203 Section 3 provides a definition of counterfeit medicines, outlines prohibited acts, and states liabilities and penalties of concerned parties. The Philippine legal definiti on of counterfeit medicine needs to be aligned to what is widely accepted by the international community and to update its scope to prevent varied interpretations due to a mix in the categories of “counterfeit medicines.”

OBJECTIVE

This qualitative narrative policy review aims to generate evidence on counterfeit and falsified medicines from grey literature and recent publications in order to propose recommendations for updating the legal framework to address specifically “falsified” medical products.

METHODS

An online search was performed to identify relevant literature that discussed counterfeit medications. A review of narrative textual evidence from grey literature was conducted including extraction of data on the proliferation of fake, unregistered, and substandard medicines from published news articles and reports for the past six years. A review of published literature was also conducted to supplement findings from aforementioned reports and articles.

RESULTS

Literature search revealed that the presence of counterfeit medicines remains prevalent in the country despite the enactment of RA 8203. Counterfeited products include over-the-counter medicines, prescription medicines, and vaccines. The classification of counterfeit medicines in grey literature, including news articles and FDA advisories, are aligned with the WHO definitions.

CONCLUSION

There is a clear need to update the regulatory framework on counterfeit medicines which would entail revisiting RA 8203 to amend the definition of counterfeit medicines and other related provisions in alignment with the WHO definitions.

Human ; Philippines ; Drugs ; Medicine ; Pharmaceutical Preparations