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NAST PHL spearheads multi-sectoral discussion on science-based herbal industry in the Philippines

The National Academy of Science and Technology, Philippines (NAST PHL) spearheaded the Roundtable Discussion on Strengthening the Science-Based Herbal Industry in the Philippines: Issues, Challenges and Solutions on 15 February 2012 at the Traders Hotel, Pasay City. Organized by the Health Sciences (HS) Division, through Academician Jaime Montoya, in coordination with NS Dolores Ramirez of the Agricultural Sciences (AS) Division, this RTD was co-sponsored by the Department of Science and Technology (DoST) and AGHAM Party-List.

Participants were invited from various sectors like the pharmaceutical industry sector, academic institutions, and government organisations. Invited experts included Dr. Francis Vicente Ras, head of Training and Education Division of the Philippine Institute for Traditional and Alternative Health Care (PITAHC), Dr. Rainier Villanueva, founding president of the Chamber of Herbal Industries of the Philippines, Inc. (CHIPI), Dr. Lourdes Cardenas, professor of the University of the Philippines Los Baños (UPLB), Dr. Irene Villaseñor, professor of UP Diliman, Dr. Gemiliano Aligui, president of the Tropical Disease Foundation (TDF) and Acd. Montoya. Acd. Antonio Miguel Dans, member of the HS Division of NAST PHL, provided the synthesis of the discussion.

The PITAHC, according to Dr. Ras, is mandated by Republic Act (RA) 8423 to accelerate the development of traditional and alternative health care and integrate traditional and alternative medicine into the national health care delivery system. It addresses the present needs of the people through the provision and delivery of traditional and alternative health care. Aside from these functions, PITAHC is also responsible for the production and marketing of different herbal products. Its research function is concentrated on herbal medicines using the guidelines of the World Health Organization (WHO) and currently collaborating with two units of UP Manila ― National Institute of Health and College of Pharmacy. Some of the current issues in the development of traditional medicine in the Philippines include PHITAC’S inability to enforce standardizations and regulations; inadequate promotion for public awareness and access to traditional and alternative medicine; and minimal government funding for research. To be able to address these issues, PITAHC plans to (1) revise the Traditional and Medicine Act to strengthen traditional and herbal medicine regulations; (2) communicate and cooperate with different levels of local health care to create a more formal referral network between traditional medicine practitioners and biomedical practitioners; (3) collaborate with national and private health insurance providers in the creation of benefits and incentives for patients and practitioners, respectively; (4) identify measures to expedite funds for research; and (5) improve documentation of indigenous traditional knowledge on health care practices.

Acd. Montoya showcased the development of science-based herbal products for health and wellness. According to him, out of 10,000 compounds screened, only 5 reach clinical testing, and only one compound will make it as a drug. This could take up 12–15 years on the average costing around $1.2–$1.6 billion. Some of the options he presented for consideration included the following: (1) development or outsourcing of expertise; (2) awareness of other pre-clinical assays; (3) consideration of the type of throughput screening; (4) establishment of centralized facilities; and (5) conduct of pre-clinical testing screening only and licensing out of lead compounds to drug companies.

Dr. Cardenas presented the issues related to ensuring the quality of raw materials for use in herbal products. She reiterated that it is best to know the plant source, including the physiology, common diseases, intentional and unintentional adulterants, chemical and molecular fingerprints, and other aspects. A voucher specimen should also be placed in a gene bank. With regards to the processing of raw materials, choose the best process to keep the active ingredient(s) intact with the cost within budget, provide the best storage, and know the shelf life if raw materials are not used immediately.

Dr. Villaseñor, on the other hand, presented the establishment of quality parameters for herbal products. Herbal products undergoing toxicity and mutagenicity studies could become health supplements while those undergoing clinical studies (phases I–III) are classified as traditional medicines. Although health promoting plant drugs have immediate economic and social benefits that could develop local pharmaceutical industries, there are causes of concern such as the correct and unequivocal identification of the plant and the proper design and execution of clinical trials. Lead compounds that undergo toxicity, mutagenicity, and clinical studies could be designated as standardized traditional medicines or classified as targeted or designer drugs.

Dr. Aligui talked about clinical evidence in relation to the establishment of confidence in herbal products. Presently, there are two administrative orders (AOs) that govern traditional medicines, namely: AO 172, Series of 2004, which deals with the registration of herbal medicines and AO 184, Series of 2004, which focuses on the registration of traditionally-used herbal products. Clinical trials should conform to the Good Clinical Practice Guidelines (GCPG) and validated by the National Integrated Research Program on Medicinal Plants (NIRPROMP of the PCHRD-DOST) or by other competent research centers accredited/approved by FDA.

Dr. Villanueva presented the views of the private sector. He recognised government initiatives in promoting the natural products industry, particularly from the Departments of Trade and Industry (DTI), Agriculture (DA), and Health (DoH) that have been helping the industries. Unfortunately, there are still problems that they encounter such as: (1) lack of enough scientific evidence to support claims of the advantages of herbal products; (2) policies by FDA on product registration that need updating; (3) no standardisation of natural ingredients; (4) existence of businesses negatively taking advantage of the popularity of natural and organic products; (5) lack of integrated programs by the different agencies of the government to strengthen the industry; (6) minimal or no implementation of good agricultural practices (GAPs) among the agricultural sector; (7) absence of clearing house or non-centralization of government funded R&D efforts on herbal products; (8) lack of laboratory facilities dedicated to the natural products industry; and (9) the non-attractiveness of the intellectual property (IP) guidelines on government-funded research projects.

According to Melody Zamudio of the Food and Drugs Administration (FDA), the harmonization of the technical requirements for traditional medicines will be implemented next year. These initiatives are in conjunction with the proposed ASEAN Harmonization on Traditional Medicine and Health Supplements. This scheme will establish standardization for all kinds of traditional and alternative medicines in the Southeast Asian region that other parts of the globe should follow. Acd. William Padolina, member of the NAST PHL Chemical, Mathematical and Physical (CMPS) Division, however cautioned the FDA and other Philippine representatives for implicit trade-offs and marketing strategies that may or may not uplift the welfare of the Philippine natural products industry. Atty. Joey Ochave of UNILAB Inc. added that (CGMP) only audits local pharmaceuticals. This is actually a hindrance to development, according to him, as foreign pharmaceuticals are not audited when they market their products in the country.

DA Biotech Director Dr. Candida Adalla shared that the DA has developed and is implementing a roadmap on natural ingredients. On the other hand, Elizabeth Geronilla of the Palawan State University (PSU) cautioned the audience that poaching of endemic organisms might occur and argued that laws like Executive Order (EO) 247 (Bioprospecting Act) should be taken into account. Local communities should also be protected as they might be neglected and may receive royalty less than what they fully deserve, or much worse none at all.

Currently, only the UP System has the capacity to undertake the full steps of drug discovery in the country, according to Acd. Montoya. UP is strengthening programs to engage other academic institutions and research organizations in collaborative research efforts.
 
Acd. Dans, in his synthesis, said that the presentations tackled the production, clinical evaluation, marketing and regulation of herbal products. With the harmonization efforts undergoing refinement in the SEA region, there are issues that should be thoroughly studied for the benefit of Philippine natural product industries. Scientific standards must be established. The principle of secrecy, lack of incentives for researchers and the lack of venues for publishing researches and clinical studies must be looked upon and examined for the development of science-based herbal industry in the country. According to him, the most important thing that must be considered is the science of effectiveness, as these herbal products and drugs should be effective to those who are going to use them— the patients. (Dexter Bautista)

Last Updated on Tuesday, 06 March 2012 07:25
 

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