Access to medicines in developing countries – what likely impact will GSK’s move have?

GlaxoSmithKline (GSK) has announced an expansion of its efforts to widen access to medicines in the poorest countries.

The commitments are:

• not to file for patent protection in Least Developed and Low Income Countries
• to grant licences to generic manufacturers to supply versions of GSK medicines in Lower Middle Income Countries
• to commit future oncology products to patent pooling, and
• to make information about its patent portfolio freely available.

GSK has long been at the forefront of developments of access to medicines and these measures are clearly a very welcome statement from the company, which some commentators have suggested is an attempt by Sir Andrew Witty, GSK's CEO, to cement his legacy.

However, Sir Andrew accepts that these measures alone will not be enough. He acknowledged that:

"Changes to patents and IP systems will not solve the multi-faceted challenges of improving healthcare in developing countries. In cancer for example, improving outcomes in developing countries requires better funding, improved screening and diagnosis, more cancer doctors and better hospital services as well as access to treatments…"

So how will these measures affect the access to medicines? First, it is necessary to consider which countries are affected. Least Developed and Low Income Countries are listed by the World Bank and include most of Africa. GSK will not file for patent protection in these countries.

However, there are likely to be a limited number of manufacturing plants in these countries and so an absence of patent protection at the site where the medicines are needed may not necessarily improve access to medicines because the medicines will need to be manufactured in locations where there is patent protection in place.

Therefore, GSK would need to grant licences or not enforce its patents at the site of manufacture to ensure access to medicines.

In Lower Middle Income countries, GSK will seek to grant licences. This list includes India and so would provide some potential for medicines to be manufactured under licence to supply to the Least Developed and Low Income countries where there was no patent protection (at least on GSK products).

So, despite countries such as China and Brazil not benefiting from GSK's efforts because they are Upper Middle Income countries, the measures do have some potential to have an effect on access to medicines, particularly those manufactured in India, on the basis that a licence will be granted.

It is interesting to consider some of the measures that have been adopted previously to address this problem and consider whether or not GSK's commitments would be able to produce a similar result.

Article 31bis

Rwanda, which is a Low Income country, was the first (and only) country to make use of the compulsory licensing provision, 31bis of TRIPs. Canadian company Apotex Inc. was awarded a compulsory export licence under the provisions to supply a combination AIDS drug to satisfy Rwanda's health needs.

The procedure under which this compulsory licence was granted required Rwanda to notify the WTO that based on its public health needs Rwanda expected to import 260,000 packs of TriAvir (a combination of Zidovudine, Lamivudine and Nevirapine used to treat HIV/AIDS) over two years.

Apotex tried to negotiate with the patentees, in this case GSK, Shire and Boehringer Ingelheim, but was unable to agree and so applied successfully under the Canadian legislation implementing article 31bis of TRIPs for an export licence to supply TriAvir to Rwanda.

Apotex was critical of the "unnecessarily complex" system and claimed that it did not "adequately represent the interests of those who require treatment". Apotex's compulsory licence was granted in 2007 and the mechanism has not been used since.

So would GSK's commitments apply in this situation? It would appear not. Canada is a High Income country and so one in which GSK will seek to enforce its patent rights. Indeed, GSK did not agree a licence with Apotex in 2007, although it did not oppose the grant of the compulsory licence.

Compulsory licences

A number of compulsory licences have been granted under national legislation to provide access to medicines and I consider a few examples below:

• In 2006, Thailand issued a compulsory licence to import Merck's drug efavirenz from India.
• Similarly, in 2007, Brazil awarded a compulsory licence to import efavirenz from India.

In neither case was there any patent protection in India so the manufacture of the medicines could not be prevented.

Under GSK's proposals, of course, even if there had been patent protection in India, GSK would have sought to grant a licence. The difficultly might occur in Thailand and Brazil, both of which are Upper Middle Income countries and so ones in which GSK might seek to enforce its patent rights. A compulsory licence would still therefore be required.

In 2004, Zambia granted a compulsory licence to a Zambian national company for a triple combination AIDS therapy and Indonesia granted a compulsory licence to its government in respect of a double combination AIDS therapy.

Both Zambia and Indonesia are Lower Middle Income Countries and therefore ones in which GSK will seek to grant licences. For GSK drugs, a compulsory licence might not be necessary under a graduated approach to patents and IP.

Conclusion

GSK's graduated approach to patents and intellectual property to widen access to medicines in the world's poorest countries is clearly a very welcome move. Of course, these measures alone will not solve a very complex problem, but it’s a step in the right direction.

This article originally appeared in PharmaFocus.