Public health experts have welcomed the new approach of some pharmaceutical companies towards unveiling new patent policies facilitating access to innovative medicines in low- and middle-income countries.
The Medicines Patent Pool (MPP), a public health organisation funded by the United Nations, is a key driver of this trend. The MPP is dedicated to improving access to treatments for HIV, viral hepatitis, malaria, and tuberculosis for patients in low-income countries with the negotiation of large-scale licensing agreements between drug developers and multiple generics manufacturers. The organisation’s voluntary licences (VLs) offer some countries the opportunity to gain access to affordable generic versions for HIV and hepatitis C virus (HCV) treatments.
The MPP has added new VLs, and increased their geographic scope or added new formulations to other licences. In 2014, the MPP announced a new agreement with AbbVie (US), for two specific paediatric formulations of LPV/r, covering 102 low- and middle-income countries. In 2015, a separate agreement was signed between MPP and AbbVie on the adult formulation of LPV/r which only covers African countries.
The VL for tenofovir now includes tenofovir alafenamide (TAF) and has an expanded geographic scope that allows generic producers from South Africa and China to join.
The VL for elvitegravir (EVT) was amended to include production in China and South Africa, provided that products are made from the US firm Gilead-licenced producers of active pharmaceutical ingredients (API).
In March 2016, GlaxoSmithKline (UK) announced that it would increase the geographic scope of its voluntary licensing agreements to include all lower-middle-income countries. The MPP’s VL for its HIV medicines Tivicay (dolutegravir) has been expanded to include Ukraine, Morocco, Moldova, Armenia and 14 other low- and middle-income countries.
In July 2016, MPP announced new manufacturing licences for a generic copy of Bristol-Myers Squibb’s (BMS, US) Daklinza (daclatasvir) tablets for the treatment of HCV. MPP has signed licences with India-headquartered Aurobindo, Cipla, Emcure, Hetero Labs, Laurus Labs, and Zydus Cadila and China-based Desano for a total of nine new sub-licensing agreements to produce generic versions of key World Health Organization (WHO)-priority HIV and hepatitis C treatments.
Criticism of these VLs has centred on the fact that they tend to exclude some upper-middle-income countries, such as Brazil, may require generics companies that sign the licence agreement to forego the right to supply specific countries that they currently have the right to supply, and the perception that they could allow branded companies to influence the practices of generics companies, including for unrelated products, and undermine the neutrality of the MPP in managing the sub-licence agreements.
Additionally, the MPP has so far been focused on treatments for infectious and neglected tropical diseases such as HIV/AIDS and HCV treatments, but VLs have yet to see the same activity for oncology treatments for example. This is despite the fact that the WHO estimates that cancer kills more than 5.3 million people in developing countries each year, making it deadlier than HIV/AIDS, tuberculosis and malaria combined.
However, some companies such as Novartis have adopted alternative measures, in this case launching last year a programme to enable access to 15 medicines for several non-communicable diseases (including breast cancer), for USD1 per treatment per month. The programme has started distributing drugs in Kenya and Ethiopia, and there are plans to implement the programme in about 30 low- and lower-middle-income countries.
Similarly, GSK decided in March to stop filing for patents in 50 least developed and low-income countries, such as Afghanistan and Zambia. That should make it easier for other manufacturers to supply generic versions of GSK’s drugs in those countries without fear of litigation, and other pharmaceutical firms, including Merck KGaA (Germany) and Roche (Switzerland), have previously announced similar moves.
GSK chief executive Andrew Witty, also announced that for a further 35 lower-middle-income countries in which GSK will continue to file for patents, the company will grant licences to generics manufacturers who will then be able to make copycat drugs for domestic use and export. GSK also suggested that it is considering licensing via the MPP some of its oncology treatments.
Thus, a variety of new approaches that the pharmaceutical industry is implementing are playing a role in facilitating access to medicines in some low- and middle-income countries. This is considered essential, as many countries in the world seek to scale up access to ARV and hepatitis C medicines, in line with WHO treatment guidelines.