In light of the announcement of GSK's IP scaleback in developing countries, Simon Cohen asks whether this new approach will improve access to medicines for the world's poorest
The world healthcare community will welcome GlaxoSmithKline's recent announcement that it is to take a 'graduated approach' to patents and intellectual property (IP), which reflects each country's economic maturity.
There have been a number of attempts to widen access to medicines in the world's poorest countries, however, results have been mixed, leading many to question whether such measures do materially improve access for those that really need it.
GSK's press statement set out the details of the affected countries. Firstly, GSK will not file for patent protection in those countries listed by the World Bank as Least Developed and Low Income Countries, which includes most of Africa. Secondly, in Lower Middle Income countries (LMICs), including India, GSK will seek to grant licences to generic manufacturers to supply versions of GSK medicines. Finally, GSK is to commit future oncology products to patent pooling and make information about its patent portfolio freely available.
Looking more closely at the first commitment not to file for patent protection in the poorest countries, it is difficult to see what difference it will make. After all, these countries are not likely to have either a large number of manufacturing plants or significant markets for patented medicines. Consequently, this commitment may not significantly improve access to medicines, although it is welcome nevertheless.
The second commitment – to work with generic manufacturers in LMICs – would provide some potential for the manufacture of medicines under licence. Although countries such as China and Brazil will not benefit, the measures have some potential to improve access to medicines, particularly those manufactured in India.
With the patent pooling of oncology products, GSK pointed to ViiV Healthcare's agreements with the Medicines Patent Pool (MPP), a UN-backed initiative to facilitate voluntary licensing of innovative HIV, hepatitis C and tuberculosis treatments in LMICs. As two-thirds of the 8.2 million deaths from cancer in 2012 (WHO) occurred in these countries, it certainly seems time for the MPP to tackle this.
One such agreement between the MPP and ViiV Healthcare – a specialist HIV company majority-owned by GSK along with Pfizer and Shionogi – aimed to facilitate the manufacture and sale of generic versions of ViiV's innovative treatment Tivicay (dolutegravir) in least-developed, low income, sub-Saharan African and specific middle-income countries, where the need is most pressing. How this approach will work in oncology depends on the detail of whatever agreements are made with the MPP.
Finally, GSK has committed to make information about its patent portfolio freely available. While extra transparency is welcome, patent information is already reasonably available so mere additional knowledge does not do anything to help access in itself. Therefore, it is difficult to see how this will make a meaningful difference in widening access to medicines in the world's poorest countries.
In conclusion, while cynics have suggested these measures are an attempt by Sir Andrew Witty, GSK's CEO, to cement his legacy, this is unduly harsh. Sir Andrew accepts that GSK's proposals are no panacea: "Changes to patents and IP systems will not solve the multifaceted 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."
While these commitments are certainly a step in the right direction, we will have to wait and see if other pharmaceutical heavyweights follow suit.
Simon Cohen is a partner and head of international patents at law firm Taylor Wessing. He can be contacted at firstname.lastname@example.org