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GSK shows a 'human face' but access of medicines to remain a challenge

UK-based pharma company GlaxoSmithKline and one of the oldest pharma MNC in India, has announced that it will not file for patents in the low income countries.

By E. Kumar Sharma        Last Updated: April 7, 2016  | 16:31 IST

E Kumar Sharma, Associate Editor, Business Today
UK-based pharma company GlaxoSmithKline and one of the oldest pharma MNC in India, has announced that it will not file for patents in the low income countries. In other words, it will allow companies to make copycat generic drugs in these markets, either without paying any royalty to them or with a small royalty fee.

GSK is not the sole pharma company to make such a move, earlier global pharma majors Merck and Roche too had made similar announcements.

What do moves such as these mean for global pharma majors and what will it mean for India? For the global pharma majors, these markets (low income countries)  typically do not contribute much financially so it is unlikely to mean anything significant to their bottomline but it would be according to critics "a good move that showcases their human face."

As for India, it does not mean much to the patients here as the country has outgrown this status so the MNCs will continue to file patents in India. It is therefore perhaps with good reason that Knowledge Ecology International (KEI), the global not-for-profit non-governmental organization, seeks more to expand access to patented medicines.

Hailing the step taken by GSK CEO Andrew Witty, who incidentally has spent many years in the developing countries, KEI in its statement says: "Sir Andrew Witty has shown exceptional leadership, and we look forward to the implementation of this ambitious set of initiatives. In our view, even these welcome measures are not enough, and we continue to press for global de-linkage of R&D costs from drug prices, and open licenses on all products."

"The GSK decisions on filing and licensing patents on other products in lower income countries, and the commitments on pricing and transparency, are all welcome initiatives. Other companies, such as Roche, Novartis, Bayer, Astellas, and BMS, with important oncology drugs should begin to engage on expanding access to their patented medicines, beyond just HIV and HCV drugs," it adds.

If it's not India then which are these countries. Going by the UN list of least developed countries  (See the full list here http://www.un.org/en/development/desa/policy/cdp/ldc/ldc_list.pdf ) these include countries like Afghanistan, Angola, Ethiopia, Gambia, Sudan and Zambia.
 
However, the list also covers countries around India - Afghanistan, Bangladesh, Bhutan and Nepal plus includes Myanmar.

Could this mean anything for Indian pharma companies? According to pharma companies it does not mean much, especially to India's leading companies that are becoming global generic majors and focus largely on the western markets, led by the US.

But there could be some implications for small and mid-sized Indian pharma companies. Depending on the capabilities, it could open an opportunity for the small and mid-size companies those below Rs 1000 crore to either consider export of these drugs to these countries, if the provisions allow perhaps with a license from the MNCs concerned or set up units in these countries.

GSK announcement on March 31 said, "For Least Developed Countries (LDCs) and Low Income Countries (LICs), GSK will not file patents for its medicines, so as to give clarity and confidence to generic companies seeking to manufacture and supply generic versions of GSK medicines in those countries. For Lower Middle Income Countries (LMICs) generally, GSK will file for patents but will seek to offer and agree licences to allow supplies of generic versions of its medicines for 10 years. GSK intends to seek a small royalty on sales in those countries. This offer will apply even for those countries that move out of LMIC status due to increased economic growth during this period."

It also adds: "For High Income Countries, Upper Middle Income Countries and G20 countries, GSK will continue to seek full patent protection. Any GSK medicines on the WHO's list of essential medicines will be included in these changes."

While access to costly MNC medicines will remain an issue in India and elsewhere, the Knowledge Ecology International sums it up well: "People live and die in both the short and the long term, and the GSK announcement means more cancer patients will live longer and better lives in the near term, and that is a good news."

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