Refuse trade, investment provisions that threaten access to affordable meds

Positive Malaysian Treatment Access & Advocacy Group (MTAAG+) calls on the Malaysian government to reject trade and investment agreement provisions that threaten access to affordable medicines.

MTAAG+ asserts the need to make its position and demand known because of the confusion that has arisen surrounding US President Donald Trump’s Executive Order for his government to formally withdraw from the Trans-Pacific Partnership Agreement (TPPA).

MTAAG+ opposed the TPPA, and thus congratulates the American people for having successfully killed a trade deal with 11 other governments that would have put foreign investors and corporate profits ahead of the welfare, interests and future of the people, public health and the environment.

We oppose the TPPA, but not for the same reasons as Trump’s 

But Trump’s motivations for withdrawing from the TPPA are not, of course, out of concern for the people nor for the environment; it would be laughable if it was not tragic that the corporate-linked millionaires and billionaires who make up Trump’s Cabinet are not expected to chart a course any differently from the US’ decades-old deeply flawed trade agenda but to entrench and expand their interests.

Unlike Trump and his Cabinet, MTAAG+ is gravely concerned that the withdrawal of the US from the TPPA does not eliminate the dangers that MTAAG+ members and hundreds of millions of other people, who depend on essential medicines to live, face as long as provisions are included in trade and investment agreements that will harm access to affordable medicines.

And this is where attention should focus, from the TPPA to the many other trade and investment agreements that Malaysia and other governments are on the verge of signing that contain provisions restricting access to cheaper generic medicines.

Why? Because these other trade and investment agreements – particularly the Regional Comprehensive Partnership Agreement (RCEP) currently being negotiated between Malaysia, its ASEAN partners, and  Australia, India, China, Japan, South Korea and New Zealand – contain even bigger threats to access to affordable medicines than the TPPA had posed.

Recounting our warnings about the TPPA, we had pointed out that the TPPA increased the level of Intellectual Property protection on medicines and thereby jeopardise access to affordable medicines in that:-

  •        it would have enabled drug companies to press for patent term extensions beyond the standard 20 years, to be compensated for any “unreasonable” time that a patent office or drug regulatory authority takes to approve a patent application or grant marketing approval;
  •        patent term extensions would have significantly delayed the entry of cheap generic medicines into the market;
  •        generic companies would have been prevented for 5 years from registering an equivalent generic version of a patented drug for market approval based on originator company data, thereby curbing the supply of cheaper drugs. While Malaysia already has data exclusivity guidelines, the Malaysian provisions have various safeguards, while the TPPA would have locked in the tougher monopoly;
  • market exclusivity extends to the new generation of “biologics” medicines (medicines derived from proteins isolated from plants, animals and micro-organisms) that have been developed to treat human diseases and conditions, such as vaccines, cancer medicines and therapies such as insulin;
  •        under the TPPA, Malaysia would have had to provide 5 years’ market exclusivity for biologics. Malaysian law currently does NOT have data or market exclusivity for biologics and therefore would have to be amended to incorporate this;
  •        the number of years of biologic exclusivity has led to such high prices that even the Obama administration had repeatedly sought to reduce the number of years of biologic exclusivity in that country;
  •        “Evergreening” of already existing monopolies would have happened through market exclusivity if a “new” medicine is an old drug that has been found to be useable for a condition other than that which it was originally developed to treat, or for old medicine that has been found to be useable for a different population of patients; or
  •        a pharmaceutical company can also seek under the TPPA additional exclusivity for new combinations of an old drug and a new chemical entity.


RCEP bigger challenge

In terms of access to health, RCEP presents an even bigger challenge as some of the relevant provisions go not only beyond the Trade-Related Aspects of Intellectual Property Rights (TRIPs) Agreement signed by Malaysia and other countries at the WTO, but also beyond the TPPA (thus, ‘TPP-plus’) in that the RCEP leaked Intellectual Property draft chapterprovides for longer patent term extensions and data (instead of market) exclusivity for 5 years for small molecule medicines. Data exclusivity for 5 years is a longer monopoly than market exclusivity for 5 years because the generic cannot apply during the exclusivity period under data exclusivity, unlike market exclusivity. These provisions will lengthen monopoly periods of patented medicines or those protected by data/market exclusivity by delaying the entry of generics into the market.

Most importantly, India is part of the RCEP negotiations, is the world’s largest producer of generic medicines and supplies more than 80% of generic anti-retro viral (ARV) medicine to treat HIV in low and middle income (LMIC) countries. Its generic medicine industry has reduced the cost of ARV medicines over time by up to 98%.

Malaysia provides Indian generic ARVs free of charge to our HIV positive population. Without access to such generic medication it is questionable whether Malaysia can sustain its HIV treatment programme especially in light of the recent budgetary cuts for health expenditure in the country.

In January 2016, the Malaysian government slashed its allocation to the Health Ministry by between RM250 million and RM300 million, at a time when more and more citizens are turning to public healthcare in view of the rising cost of living.

MTAAG+ reiterates its long-stated position that Malaysia should not change its laws to comply with the corporate-driven demands of ‘new generation’ trade laws such as the TPPA which is now of uncertain fate with the US withdrawal. Malaysia should also reject any anti-public health provision in RCEP.

Contact Director, Mr Edward Low +6012-32278812

This entry was posted in Data Exclusivity, Patent Term Extension, Regional Comprehensive Economic Partnership, TPP, TRIPS, TRIPS plus, Uncategorized. Bookmark the permalink.

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