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What seems to be at stake here is not the safety of the patients but rather the profits of a booming pharmaceutical market.

What seems to be at stake here is not the safety of the patients but rather the profits of a booming pharmaceutical market.

Three decades ago, at the 35th World Health Assembly (WHA), in 1982, a coalition of non-governmental organizations from 26 countries, Health Action International (HAI), circulated a draft proposal for an international code of conduct to regulate the marketing practices of pharmaceutical companies. The objective of the code was “to resist the ill-treatment of consumers by multinational drug companies” and to “enable consumers, particularly those from developing countries, to procure safe and effective pharmaceuticals essential to their real health needs, at costs they can afford.”

The pharmaceutical sector and the U.S. government strongly opposed HAI’s code. In an interview with SCRIP, the trade journal of the US pharmaceutical sector, the Director of the Office of International Health at the U.S. Department of Health and Human Services, Dr. John Bryant, said that the U.S. government was “irrevocably opposed” to a WHO marketing code (Starrels 1985). And so in the progress report on the Action Program submitted to the WHA in 1982, the HAI code was omitted from the list of commitments. Instead, the Federation of Pharmaceutical Manufacturers and Associations (IFPMA) suggested a self-regulating marketing code.

After this failed attempt to issue an international code of conduct on pharmaceuticals, it became clear that each country was on its own when it came to protecting the health of its population. Since then the World Health Organization has worked more as a provider of voluntary guidelines than as a standard setting body. Additionally, each country created its own form of agency or office with the duty to guarantee the safety and efficacy of pharmaceutical products. Round 1 was over.

Since that first round, the focus of global advocacy on pharmaceutical regulation has shifted toward efforts to change the model of innovation for the sector. Advocates and some governments believe that by changing the way pharmaceutical innovation is produced and rewarded, many of the side effects of having private and powerful companies producing valuable public goods –including undesired marketing practices- would disappear. Although some progress has been made on this front, we are far from having a viable alternative to conventional IPRs to foster innovation.

However, what has since received little attention is how the autonomy granted to countries in the 1980s to regulate their own pharmaceutical sector operates as a “divide and conquer” mechanism by which powerful pharmaceutical companies pressure each state individually to pass regulation that favors their corporate interests.

This can be illustrated by a recent episode of the health versus trade saga.

In July 2014 the Colombian Ministry of Health published the fifth and final draft of a decree that regulates market access of biotech drugs. The decree was met by strong criticism on the part of multinational pharmaceutical corporations and sparked comments from the U.S. Food and Drug Administration (FDA), the U.S. Trade Representative (USTR), the U.S. pharmacopeia, the European Medicines Agency (EMA), the European pharmacopeia, among others (all the comments received and the responses can be viewed here). All of these actors question the Colombian regulation because it includes an abbreviated pathway for the approval of bio-competitors, which they argue threatens the safety of the patients. They have even produced videos to “educate the general public” that misleadingly claim that the regulatory framework threatens patient safety.

However, what seems to be at stake here is not the safety of the patients but rather the profits of a booming pharmaceutical market. The world biotech pharmaceutical market is now worth close to 340 billion dollars and it is mainly composed of patented compounds; those patents have begun to expire in recent years and competitors all over the world are getting ready to enter the market. In this context, and as other countries begin to issue sanitary regulations for marketing approval of bio-competitors; the Colombian regulation threatens valued monopolies.

There are signs that the panorama of biotech regulation is shifting. In May 2014, the World Health Assembly passed resolution WHA67.21 on “Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy”. Surprisingly, an agreement to revise and update WHO 2009 Guidelines on evaluation of similar biotherapeutic products taking into account the technological advances and considering national regulatory needs and capacities, was reached. This could be a good opportunity to bring to the table and globally challenge the unnecessary barriers that bio-competitors currently face when trying to access the market. Yet another round of health versus trade has begun.

Of interest: Public Health / Trade

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