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13 May 2015Americas

AIDS group warns of TPP’s impact on access to generic medicine

The Foundation for AIDS Research has warned that the Trans-Pacific Partnership’s (TPP’s) changes to IP policy could restrict access to affordable generic medicines in low and middle income countries.

The TPP is a free trade agreement between the US and 11 other countries that have borders on the Pacific Ocean.

It is rumoured to be nearing conclusion, though the only public details available about the agreement are those that were leaked late last year by journalistic organisation Wikileaks.

The leaked documents proposed changes to IP policies that will expand existing protections available for drug products.

In its report published last Friday (May 8), the Washington, DC-based group, known as amfAR (American Foundation for Aids Research), said that the proposed changes would delay generic competition, raising the prices of and compromising access to medicines used to treat HIV/AIDS, cancer, tuberculosis and hepatitis C.

“The IP provisions under consideration go well beyond the standards established by the [TRIPS Agreement],” amfAR said in the report, adding that the TPP’s proposals could set a “dangerous precedent” for future free trade agreements.

According to amfAR’s report, the proposed TPP will also make it easier for drug companies to get patent term extensions, reverse the burden of responsibility so that patent challengers would have to prove a patent’s invalidity rather than the patent owner, and would expand the scope of patentability to include plants and animals.

The organisation also said there is evidence that the US is pushing for the data exclusivity period for biological products to be 12 years across all TPP countries, in line with the US standard, which would block the US’s efforts to lower the level of protection to seven years.

Data exclusivity protection stops regulators from using existing clinical trial data to approve generic or biosimilar versions of drugs.

Pharmaceutical groups in the US have shown their support for the TPP’s proposed changes related to data exclusivity.

In a 2013 editorial titled “TPP and Intellectual Property”, the Pharmaceutical Research and Manufacturers of America said that the 12-year period of data exclusivity “struck the right balance that allows companies to continue to innovate and develop the next life-saving medicine, while also providing patients the treatments they need to live longer, healthier lives.”

The Biotechnology Industry Organisation also supported the 12-year period, and said in 2013: “A successful TPP Agreement will create an environment that promotes collaboration and innovation.”

However, the agreement has been opposed by US Senators Bernie Sanders, who has  labelled the TPP “disastrous”, and Elizabeth Warren, whose editorial for newspaper The Washington Post was quoted in amfAR’s report.

The brief also quoted Nobel Prize winner in economics Paul Krugman, who said in The New York Times: “This is not a trade agreement. It’s about intellectual property and dispute settlement; the big beneficiaries are likely to be pharma companies.”

amfAR concluded: “The history of IP provisions in previous FTAs has shown that they get progressively stronger and make access to medicines more difficult for those most in need.”

It added: “The TPP’s movement toward stronger IP protections should be reversed to prevent unnecessary and harmful effects on global health.”

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