The Southeast Asian pharmaceutical industry is at a crossroads: The transition from underdeveloped nations to developing and now emerging markets has brought with it many conundrums and many opportunities. The shape of the sector across the region is expected to drastically change, and today's picture is evolving quickly. Every country of the region and its national industries faces challenges associated with its socioeconomic conditions and industrial history. But, the novelty is that a set of common threats and opportunities is surfacing across the region that should determine the near future of the sector as a collective, increasingly unified, and certainly more global group of actors competing across a larger market space.
Started as a joint effort to promote economic cooperation and the welfare of the people in the region, ASEAN has increasingly evolved over the years into an economic forum doubled with instruments of economic action. At a 2003 meeting in Bali, it was stated that the objective is to set up an ASEAN economic community by 2020. Eleven key sectors, including the healthcare sector, were identified as priorities for the integration effort.
The first anticipated stepping stone will be the 2008 ASEAN Free Trade Agreement (AFTA), which will be held in January 2008. Covering a wide range of items, this agreement will unify a market space of more than 500 million people across 10 countries. It will affect the pharmaceutical industry by allowing companies to trade freely and register products across the region. Of course, the dream of a fully free market is still far away because some protection mechanisms will still be available to states that still wish to play by their own rules. But, provisions are to be strictly framed and will be more constraining than opening up to the free and fair trade. In the meantime, the industry is looking at unifying the norms and standards as well as facilitating registration procedures and the flow of goods, technical dossiers, and bioequivalence studies across the region.
Labeling standards for pharmaceutical and medicinal products should be established by Dec. 31, 2006. By December 2008, an ASEAN common technical dossier (ACTD) is expected to be released. Approval and recognition across the region should then be a natural step. Currently, efforts are being made to formalize a postmarketing alert system for defective pharmaceutical and medicinal products and explore the feasibility of implementing a flex-twinning system among countries with similar setups. These efforts will bring many opportunities to the region and its players, even if they will be taken primarily by those who had the foresight to turn their organizations into globally able companies. A unified market of more than 500 million potential customers is clearly a mouth-watering prospect for most regions leaders and their challengers, but it might come with strings attached.
Sec. Roberto M. Pagdanganan, Chairman & President of PITC
Exclusivity versus AFTA
While the application of a free-trade agreement is being discussed on a bilateral level between Malaysia and the United States, future members of AFTA (who must review their existing agreement with the United States before full entry into AFTA) have looked at their Malaysian neighbors with apprehension as the issue of data exclusivity has been brought forward by the United States during the discussion. These issues has triggered a wave of concerns across the Southeast Asian industry. The data at stake are all the test data (i.e., clinical data) that were produced by the originators in the course of the new molecule's development.
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