[Ip-health] Pharmalot: Pharma Is In Crosshairs At India-EU Trade Talks
thiru at keionline.org
Fri Feb 10 06:53:24 PST 2012
Pharma Is In Crosshairs At India-EU Trade Talks
By Ed Silverman // February 9th, 2012 // 11:27 am
As important trade talks begin tomorrow between the European Union and India, a growing chorus of patient advocacy groups and non-governmental organizations are imploring Indian officials to reject proposals that they claim were initiated at the behest of the pharmaceutical industry and would inhibit access to various life-savings medicines, notably treatments for HIV.
At issue are provisions in a draft agreement that would commit India to extend liability to third parties involved in making or distributing generics; allow global drugmakers to seek arbitration to resolve intellectual property disputes, which may affect public policy and pricing, and adopt data exclusivity, which would set a strict timetable for determining when generic copies can be made.
India produces “high-quality products and have made remarkable efforts to make them patient-friendly at guaranteed low prices,” UNITAID executive director Denis Broun says in a statement. “We are extremely concerned that attempts to restrict India’s ability to produce such medicines quickly and cheaply will have tragic consequences for global health programs worldwide.”
The concerns come several months after India promised not to link a trade deal with the EU to any limits on making generic AIDS drugs, according to a joint statement from India’s Commerce Minister Anand Sharma and the Joint United Nations Programme on HIV/AIDS last summer. They were responding to criticism that pharma was pushing provisions that would limit availability of AIDS meds (see here).
Which provisions concern the advocacy groups and NGOs? For instance, the draft agreement would require India to widen border enforcement so that legitimate medicines, which allegedly infringe on a trademark, could be detained or destroyed when being exported because labeling appears similar to the brand-name product.
In a letter to Indian Prime Minister Manmohan Singh, Medicines Sans Frontieres writes that this approach is justified by protecting the public from counterfeits, but has been used in Europe recently to prevent transport of legitimate generics from India en route to other nations where patient access to various treatments is limited.
The controversy over repeated seizures boiled over last year as infuriated Indian generic drugmakers complained that exporters would be forced to find alternative routes to send shipments, which would increase costs and hurt competitiveness (back story). MSF maintains this provision goes beyond the existing Trade Related Aspects of Intellectual Property Rights international agreement reached in 1994.
Another provision that has drawn protest would extend liability to third parties, which means that any number of different entities could be ensnared by an alleged trade violation, including suppliers of active pharmaceutical ingredients used for making generics; distributors and pharmacies and NGOs that provide treatment. “This could act as a significant deterrent to anyone involved in the production, sale or distribution of affordable generic medicines,” MSF argues.
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