For this particular issue, special thanks to David Pineda Ereño, IADSA Manager, Regulatory Affairs.
ASEAN: Association of Southeast Asian Nations
A few months ago, ASEAN countries agreed combine into a single market by 2015, five years earlier than the 2020 date originally planned. This united market, among other things, would involve the removal of non-tariff barriers and would presumably free up the flow of services, investment and skilled labor across the ASEAN countries.
The ASEAN countries constitute a market of 560 million people, yet account for only 6 percent of global exports. The more developed countries of the group, including Malaysia, Indonesia, Singapore, Brunei, Thailand and the Philippines are significantly differentiated economically from the other four, Vietnam, Laos, Myanmar and Cambodia.
As the next several years unfold, these countries will have to overcome numerous hurdles, including the fact that each country traditionally keeps an extremely tight hold on core industries such as banking, transport and healthcare, not unlike the challenges facing the EU, as it contemplated a single market. Unlike the EU environment though, ASEAN has its own set of hurdles it must overcome. Chief among these is the question of whether the infrastructure is in place in ASEAN to achieve its single market objectives. According to some, essential elements of the framework are not in place, such as the court structure which the EU did have, as well as a well staffed secretariat. In ASEAN, each country has a key role in spearheading the development of the regulations, while in the EU, the Commission itself is responsible for the creation of draft regulations. And although all participants will undoubtedly endeavor to be fair, the issue of favor and protected interests will likely arise. It will be interesting to observe challenges and disputes, and potentially problematic to redraft or retract rules if implemented incorrectly.
The ambitious ASEAN objective is harmonization into a single market by 2015, a very short period. In fact, when conceived in 1997, the target was 2020. The key objectives of the ASEAN alliance are to accelerate economic growth, social progress and cultural development. Its highest decision-making body is the annual ASEAN Summit of the Heads of State. The day to day operation of ASEAN is run by a Secretariat based in Jakarta, Indonesia.
ASEAN Healthcare Sector
ASEAN has identified 11 sectors as priorities for harmonization, one of which is the healthcare sector. A product working group on Traditional Medicines and Health Supplements (TMHS) has been created to ensure the harmonization of regulation in these two categories, and charged with developing, for 2010, a framework to deal with labeling, product placement, GMPs and manufacturing standards, contaminant, claims, dosages and ingredients. Common legislation would ultimately take over all national legislation and would eventually define future markets.
Some of the specific challenges this group will be dealing with include whether or not food supplements and traditional medicines will be in the same category, the allowance of claims, will food, medicine or special law apply, the establishment of positive or negative lists, will there be special rules for herbals, maximum levels for vitamins and minerals, food or pharmaceutical GMPs and whether product registration or notification procedures will apply.
So far, efforts have been focused on information gathering, as each country is analyzing their current systems. The next government meetings will involve analysis of current ASEAN member environments then recommendations for proceeding.
Driving this initiative, in general, is pressure by trade ministers to facilitate and open markets, rather than protectionist activity. Presumably a collective block will also be able to thwart trade threats from both China and India. Governments around the world understand the significance of the ASEAN development and are carefully watching especially as this alliance grapples with its health initiatives. Expect Canada, the United States and Australia to be watching extremely carefully as to how natural health products and supplements are handled.
IADSA itself recognized the importance of this issue and has been involved since 2005, as it began gathering industry in the region together. It organized a co-operative event in Thailand in January and Singapore in April, and was instrumental in the development of key positions related to this issue and in the creation of the ASEAN Alliance of Health Supplement Associations which is the representative body of the dietary supplement industry in the region. IADSA’s most recent involvement was at the formal ASEAN meetings in July in Singapore, where it participated in the 5th Meeting of the ASEAN Consultative Committee for Standards and Quality (ACCSQ) Traditional Medicines and Health Supplements Product Working Group (TMHS PWG) on July 27-28. This Meeting was preceded by a Regional Seminar on the “Regulation of Traditional Medicines and Health Supplements- The Challenges” on 26 July.
The meeting, officially opened by H.E Mr. Heng Chee How, Minister of State for Health of Singapore, was attended by delegates from Brunei Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Philippines, Singapore, Thailand and Viet Nam, and representatives of the ASEAN Secretariat and the WHO. Representatives from the Traditional Medicines and Health Supplements Industry in ASEAN Member Countries also attended the Meeting as observers.
During the course of the meeting, several observations and points were raised. These included:
(i) A risk-based approach is useful in the development of an appropriate regulatory framework
(ii) Development of negative list of herbs and toxic substances would be useful for all relevant stakeholders
(iii) Involvement of the industry and scientists to provide the expertise needed for risk assessment
(iv) Experience of the harmonization initiatives undertaken by the Australia New Zealand Therapeutic Products Authority (ANZTPA) would be a useful reference for the ASEAN harmonization of regulations on traditional medicines and health supplements
(v) The TMHS PWG could learn from the experience in the various developed countries in order to shorten the learning curve and to avoid similar problems that were previously faced by them.
The Meeting discussed and agreed to embark on harmonization in areas such as:
(i) Safety/ Quality Requirements:
- Negative list of ingredients
- Certification requirements
- Limits of Microbial Contamination
- Limits of Toxic Substances
- Limits of Pesticide Residue
- Maximum levels of vitamins and minerals
(ii) Claim requirements which include the list of prohibited claims and lists of permissible claims
(iii) Post- Marketing Surveillance.
The Philippines were asked to take a lead in establishing a Scientific Committee to look into all areas, except certification requirements and post- marketing surveillance, and to draft the Terms of Reference for the Scientific Committee.
Other next steps identified were that a Technical Workshop on GMP for TMHS would be held as soon as possible in order to identify an appropriate approach for ASEAN in developing the GMP requirements (Malaysia to assist in coordinating with Member Countries in conducting the Workshop).
It will be quite interesting to continue to follow the evolution of these discussions and the harmonization process. Questions such as the impact of this group, both on trade and external influence, as well as regulations, in India and China bear scrutiny.
As other developing areas of the world such as Latin America take new looks at regulations and processes for this sector, does this ASEAN harmonization model represent an approach to consider? It is quite evident that there are regulatory gaps around the world, and so developing a model appropriate for developing areas with the idea of exporting this model elsewhere may make sense.
IADSA role as this endeavor proceeds will be to:
Continue to support ASEAN industry associations and the regional Alliance – AAHSA - on the development of these model regulations.
Provide information and guidance to governments
Help to create associations in countries where they do not exist.
Work to build the SE Asian dietary supplement industry and market
A new regulation on dietary supplements was adopted in September by the Colombian government which improves the regulatory situation in the country and eradicates some of the major obstacles to market access for dietary supplements. In particular, this regulation expands the definition of dietary supplements allowing the combination of vitamins and minerals with other natural ingredients, ie. plants.
Although this new regulation does not provide a clear definition of dietary supplements as either food or drug and the government still considers them as drugs, their free sale is now permitted in outlets other than pharmacies, such as specialist stores and department stores.
According to this regulation, a Certificate of Good Manufacturing Practice will be requested to successfully obtain the registration of dietary supplements, a list of claims will be developed by the authorities but disease risk reduction claims would not be allowed. In addition, this regulation includes an Annex with maximum levels for a number of vitamins, minerals and oligoelements. A transitional period of 12 months is given to fulfill the requirements of this regulation.
The development of this regulation started early this year. Although it is still far from the ideal, by incorporating a number of the IADSA comments provided directly to the government and through industry representatives in the country in the last months it is a significant improvement on early drafts.
A new association is being created in the country with a clear focus on food supplements with the aim of obtaining the food status for food supplements in the country. The effective operation of the association will be critical to achieve this.