Generic Medicines, In My Mailbox
MSF Urges Countries Not to Trade Away Health as Trans-Pacific Trade Pact Negotiations Intensify
August 22, 2013, Bandar Seri Begawan, Brunei Darussalam -
The far-reaching Trans-Pacific Partnership Agreement (TPP) should be a
force for improving health outcomes for the more than half a billion
people in twelve countries affected by the pact, but instead negotiators
are moving towards finalizing a deal that in fact would restrict access
to affordable medicines and constrain governments’ ability to protect
the health of their citizens, warned Médecins Sans Frontières/Doctors
Without Borders (MSF).
“Despite more than 18 months of persistent opposition from its trading partners, the U.S. government has refused to back down from its demands for intellectual property (IP) rules designed to impede timely access to affordable generic medicines,” said Leena Menghaney, MSF Access Campaign Manager, who is attending the negotiations. “The U.S. is keen to block developing country governments from any attempt to control abusive patenting or limit drug patent terms to the internationally-agreed 20 years. These efforts are a repudiation of the U.S. government’s own prior commitments to balance commercial pharmaceutical interests with the public health interests of developing country populations.”
In this 19th round of negotiations, the U.S. may up the ante with a
new demand for 12 years of “data exclusivity” protections for biologics,
a class of products that includes many lifesaving drugs used to treat
conditions such as diabetes, cancer and hepatitis C. Data exclusivity
gives companies monopoly rights on drugs by restricting the use of
clinical trial data by drug regulators when approving generic drugs or
“biosimilar” versions of drugs and vaccines. Data exclusivity therefore
creates a new patent-like barrier to accessing medicines and vaccines,
even when these products are not protected by patents.
While the data is locked up, competitors with affordable versions of drugs in the pipeline would be forced to repeat clinical trials in order to get them approved – a costly step that is also unethical, as safety and efficacy has already been established by the originator company. The World Health Organization and other UN agencies have warned countries against implementing data exclusivity because of its harmful effects on access to medicines. Furthermore, a twelve-year demand would be at odds with the Obama administration’s own domestic proposal, which would shorten data exclusivity on biologics in the U.S. to seven years.
“Recent victories for patients in India would not have been possible if data exclusivity on medicines had been in force, which would have blocked affordable versions of exorbitantly priced biologic drugs like trastuzumab for breast cancer and pegylated interferon for hepatitis C for years to come, even when the patent has been legally revoked, has expired, or in cases where a compulsory license has been issued,” said Menghaney.
The U.S. proposal represents the most aggressive IP standards ever seen in a trade agreement with developing countries. For example, TPP countries would be bound to grant patents on new uses, new forms and new formulations of existing medicines, effectively “evergreening” pharmaceutical patent monopolies for well beyond 20 years. The practice of repetitive or secondary patenting does not contribute to the development of novel medicines, but instead serves to restrict access to existing and known medicines.
Governments have a responsibility to ensure that the final TPP agreement doesn’t exacerbate the failure of the medical research and development system to deliver affordable medicines that address the health needs of developing countries. As pressure mounts to finalize the TPP pact ahead of the October APEC summit, MSF urges countries to stand firm and reject harmful rules that jeopardize access to medicines.
My town sent me a lot of letters recently, urging me to get to know "generic medicines" and aim for low cost medical care.
Do look out for these key words:
“Despite more than 18 months of persistent opposition from its trading partners, the U.S. government has refused to back down from its demands for intellectual property (IP) rules designed to impede timely access to affordable generic medicines,” said Leena Menghaney, MSF Access Campaign Manager, who is attending the negotiations. “The U.S. is keen to block developing country governments from any attempt to control abusive patenting or limit drug patent terms to the internationally-agreed 20 years. These efforts are a repudiation of the U.S. government’s own prior commitments to balance commercial pharmaceutical interests with the public health interests of developing country populations.”
For more details on the U.S. demands, read MSF’s Issue Brief:
While the data is locked up, competitors with affordable versions of drugs in the pipeline would be forced to repeat clinical trials in order to get them approved – a costly step that is also unethical, as safety and efficacy has already been established by the originator company. The World Health Organization and other UN agencies have warned countries against implementing data exclusivity because of its harmful effects on access to medicines. Furthermore, a twelve-year demand would be at odds with the Obama administration’s own domestic proposal, which would shorten data exclusivity on biologics in the U.S. to seven years.
“Recent victories for patients in India would not have been possible if data exclusivity on medicines had been in force, which would have blocked affordable versions of exorbitantly priced biologic drugs like trastuzumab for breast cancer and pegylated interferon for hepatitis C for years to come, even when the patent has been legally revoked, has expired, or in cases where a compulsory license has been issued,” said Menghaney.
The U.S. proposal represents the most aggressive IP standards ever seen in a trade agreement with developing countries. For example, TPP countries would be bound to grant patents on new uses, new forms and new formulations of existing medicines, effectively “evergreening” pharmaceutical patent monopolies for well beyond 20 years. The practice of repetitive or secondary patenting does not contribute to the development of novel medicines, but instead serves to restrict access to existing and known medicines.
Governments have a responsibility to ensure that the final TPP agreement doesn’t exacerbate the failure of the medical research and development system to deliver affordable medicines that address the health needs of developing countries. As pressure mounts to finalize the TPP pact ahead of the October APEC summit, MSF urges countries to stand firm and reject harmful rules that jeopardize access to medicines.
My town sent me a lot of letters recently, urging me to get to know "generic medicines" and aim for low cost medical care.
Do look out for these key words:
Comments
The medical industry is not a health industry. It is hand in glove with corporate agriculture a part of the problem.
I'm not arguing with your diet argument, just saying it is not the entire story. And I do not have the answer to the next question - how many "cures" are caused by eating unhealthy foods. Probably a large amount.
In the TPP and trade liberalization debate, since the WTO battle in Seattle in 1999, the access to medicines is a serious issue, for example about making it possible for countries in Africa, India, Asia, that are not so fortunate to afford new drugs that the medical industry would argue should be kept under wraps for as long as they can get away with, selling them at exorbitant prices in the more fortunate part of the world.
Do check out Knowledge Ecology International:
http://keionline.org/
or Doctors Without Borders:
http://www.doctorswithoutborders.org/news/allcontent.cfm?id=87
or Nature.com:
http://www.nature.com/news/trade-deal-to-curb-generic-drug-use-1.11345
"“Wanted,” the notice reads, in an American old-west style font, “Negotiating text of the Trans-Pacific Partnership Agreement.” The online advert invites visitors to contribute to a reward payable to the WikiLeaks website should it manage to expose the trade agreement. As Nature went to press, the reward stood at US$24,490.
The tactic, employed by the activist group Just Foreign Policy in Washington DC, may be extreme, but it reflects a broader unease over a negotiation process that the advert says “could affect the health and welfare of billions of people”. At issue are industry-friendly rules governing drug patents that could be written into the final text of the Trans-Pacific Partnership Agreement (TPP). The provisions could boost drug development and profits for the pharmaceutical industry, but also curb the use of cheaper generic medicines in low- and middle-income nations.
“In many parts of the world, access to generic drugs means the difference between life and death,” says US congressman Henry Waxman (Democrat, California). He is one of several US politicians voicing concern over the closed-door TPP negotiations and the influence that the pharmaceutical industry is thought to be exerting on the process through US trade representatives. With the latest round of talks set to begin on 6 September [2012] in Leesburg, Virginia, public-health advocates are expressing fears that the outcome will reduce access to medicines."