The last month saw a major milestone in the patent versus patient debate. Turing Pharmaceuticals’ CEO Martin Shkreli was forced to back down after hiking the price of Daraprim, a 60-year-old drug, by 5500 per cent two months after acquiring the rights to the drug. Outrage in the US and across the world was instant and visceral, and industry organisation BIO dropped the company from their membership lists. With Turing Pharma and Shkreli now branded as pariahs in the pharma world, have we finally settled the argument that market forces should not be left to determine medicine prices? Not likely, but at least the hardliners on the pricing front were forced to rethink their position.
Just as drug price hardliners need to rethink their stance post the Turing episode, IPR experts in India now feel that on the Traditional Knowledge (TK) front, India needs to move from the closed access system of the Traditional Knowledge Digital Library (TKDL) to a form of open access, the Traditional Knowledge Docketing System (TKDS), where the rights to TK rest with the local community.
Kerala has proposed a Draft Bill on TK, which envisages the formation of people’s trusts for the protection of TK. However, it is at a very early stage and critics point out that there is as yet no clear definition of the terms of the common licenses and knowledge commons proposed by the Draft. Read more about this topic in our Oct 1-15, 2015 AYUSH special issue (See story: Battle against Bio-piracy, pages 25-27).
Besides bio-piracy, the cover story section analyses the recent US Pharmacopeia directive that requires high performance thin-layer chromatography (HPTLC) fingerprinting for all herbal extract exports. As a move towards standardisation of herbal extracts, it is welcome but industry observers feel that the August 1 deadline was too steep for smaller companies to implement these guidelines. (See story: HPTLC Defining Herbal Inc pages 22-24).
Across the world, there are many examples of traditional foods being transformed into nutritional supplements, after gathering evidence to prove their clinical impact. The Sweden-based ColoPlus has done the same for cow’s colostrum, and with the Swedish consulate playing matchmaker, found an Indian partner in the Pune-based Govardhan Milk Foods to launch the product in India post-Diwali. (See story: The journey from cow to consumption headline, pages 30-31)
The cover section also spotlights homoeopathy, a branch of alternative treatment, which has its ardent supporters as well as critics (See story, Homoeopathy: Coming out of the shadow, pages 32-35). All these issues prove that the world is evolving to an integrative therapy approach, where AYUSH is not alternative but complementary to mainstream medicine. If we want to reap the benefits, both for our patients as well as in terms of market share and profits, the AYUSH Ministry will need to ensure that we do not miss this bus.