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Trips extension for pharma sector

Wasi Ahmed | February 03, 2015 00:00:00


The country's pharmaceutical sector, despite its commendable growth, is fraught with the big question whether it would get period by way of an additional transitional period until the WTO Trade-Related Intellectual Property Rights (TRIPS) agreement comes into full force. Although the general transitional period for application of the TRIPS agreement in the case of the Least Developed Countries (LDCs) has been extended until 2021, the same will not apply to the pharmaceutical sector. This has been regarded by observers as a lost opportunity, as reviving the issue in favour of extension in future negotiations may not be easy, if not extremely difficult. Currently, under the WTO-TRIPS agreement, Bangladesh is allowed to manufacture and export any kind of generic drugs -- patented or not -- which will not be the case in the absence of a further extension.

One of the difficulties in gaining further flexibility for the pharma sector is that not many countries among the LDCs have been able to develop this sector to a level where expiry of the TRIPS transition period means much to them. The case with Bangladesh is altogether different; the country with its considerably developed pharmaceutical sector is but a loner in the league of the LDCs. This, in other words, means that Bangladesh may find it difficult to team up with the rest of the LDCs in collectively moving the issue at the WTO, as the benefits from extension will be more in favour of Bangladesh than any of its LDC partners.

It may be recalled that the Council for TRIPS adopted in June 2013 a resolution at the WTO that allows LDCs an eight-year extension on exemption from implementing intellectual property (IP) rules under the TRIPS Agreement. But the exemption excludes pharmaceutical products. The LDCs proposed for an extension that would enable them to remain exempt from implementing nearly all provisions of the TRIPS agreement, including for pharmaceutical products, until the time they are classified as "least-developed." Following the refusal of the USA and European Union to accept the LDCs' request for such comprehensive extension, the LDCs will now have to go back to the WTO ahead of the 2016 deadline to renegotiate an extension.

In the face of opposition, led by the USA and the European Union (EU), a compromise was, however, developed. The members of the World Trade Organisation agreed to extend the deadline by eight more years, until July 1, 2021 allowing the LDCs to access more affordable medical technologies such as diagnostics and medical devices for a few more years. However, this compromise does not address the looming 2016 deadline of a second transition period, which exempts the LDCs from implementing stringent IP regulations for pharmaceutical products.

Exclusion of pharmaceutical products from the general extension is viewed by many as not only harsh but unbecoming also. Experts opine that given the crucial importance of pharmaceutical products, the LDCs should insist on an unconditional extension. "It is clear that wealthy countries are ignoring the huge health challenges LDCs face by refusing to grant them a longer and more complete extension" says Médecins Sans Frontières, or Doctors Without Borders (MSF), a humanitarian medical organisation.  MSF reports that it is noticing ever more unaffordable and inaccessible medicines in developing countries that have implemented the TRIPS Agreement and for the LDCs to be forced to do the same by 2016 would be disastrous.  

The case of the WTO LDC Members for an extension of the time period within which they must become compliant with the TRIPS Agreement covers all forms of intellectual property protection under TRIPS.  Even though it is true that some LDCs have signed other treaties that might impose some IP obligations (e.g., the Paris Convention on Industrial Property or the Berne Convention for the Protection of Literary and Artistic Works), freeing themselves from the broader and stronger spectrum of IP mandates in TRIPS will enable their access to broad classes of essential public goods, including all medical commodities, educational and informational resources, agricultural resources, and green/climate control technologies. The LDCs thus must retain the right to rollback implementation, application and enforcement of patent and data rights with respect to pharmaceutical products and the right to seek further extensions of the 2016 transition period.

Some observers wonder whether the move for further extension would cover the previous extension granted to LDCs in 2002 pursuant to Paragraph 7 of the Doha Declaration on the TRIPS Agreement and Public Health covering "pharmaceutical products."  In technical terms, the 2002 extension applied with respect to Section 5 and 7 of Part II of the TRIPS Agreement, namely the sections dealing with patents and data protection. The term "pharmaceutical products" is not defined in the 2002 LDC Extension (which runs until January 01, 2016), but whatever its interpretation, its application is not as broad as all the medical technologies and commodities that would be covered under the general LDC extension request.

At home, the ministry of commerce is reportedly preparing for the negotiation on extension. Within this month (February), the ministry is to submit a proposal to the LDC group committee currently headed by Uganda. A good deal depends on how good or worse Bangladesh fairs in taking the LDC group with it in the crucial negotiation ahead.

wasiahmed.bd@hotmail.com


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