[Updated Dec 3, 2013]. USTR released a document describing several policy changes in its Trans Pacific Partnership trade agreement proposals on provisions related to the prices of medicines. It is not known whether these changes are related to public pressure that has been mounting on USTR after the leaks of its positions on Wikileaks last week. But there have been reports of increased concern being expressed on Capital Hill and to the White House about the lack of transparency in the negotiating process since the leaks, perhaps prompting this new step towards explaining some of its most controversial positions in public. This note provides some preliminary analysis of what we learn from this new statement.
[ACT-UP Paris, Link (CC-BY-SA-ND)]
EU has just modified its legislation on the customs control concerning the enforcement of “intellectual property” rights, not considering that it impedes the legitimate trade of generic medicines in Developing countries.
Generic medicines in transit seized
These past few years, several shipments of generic medicines routing through the EU have been seized under the pretext of infringing “intellectual property”, even though these medicines were not under patents in the source or destination countries. For example, a shipment of Losartan (medication used to treat high blood pressure), coming from India and headed to Brazil, was seized in Rotterdam. India and Brazil had then protested to the EU and World Trade Organization (WTO), denouncing repeated, abusive practices. As a matter of fact, in 2008 alone, 17 shipments containing generic medicines were seized by Dutch authorities
Swiss pharma major Roche has just announced that it is relinquishing the patent for its breast-cancer drug Trastuzumab (Herceptin) in India. The announcement comes in the face of mounting challenges – from both civil society and the Ministry of Health – to Roche’s monopoly on this life-saving drug.
The Campaign for Affordable Trastuzumab welcomes the announcement, that comes appropriately on India’s Independence Day and brings hope of a disease-free life for the thousands of Indian women who are battling HER2+ breast cancer.
[MPP Press Release, Link, (CC BY-NC-ND)] The Medicines Patent Pool and Roche today announce an agreement to increase access in developing countries to valganciclovir, a key easy-to-take oral medicine to treat cytomegalovirus (CMV), a viral infection that can cause blindness in people living with HIV.
[Also available as a PDF] International AIDS Society President and President-Elect Françoise Barré-Sinoussi and Chris Beyrer today expressed their support for community activists at the IAS 2013 Conference protesting at the potential upcoming restrictions in access to generic medicines for many diseases including HIV, ahead of the next round of negotiations of the Trans-Pacific Partnership Agreement and Access to medicines (TPP) taking place in Kota Kinabulu, Malaysia from July 15-25, and organized by the Government of the United States.
Yesterday it was announced that negotiators had reached “miracle” conclusion for a new international treaty for the visually impaired. This agreement was reached under conditions of unprecedented (although not always perfect) transparency and public participation. And according to initial stakeholder opinions voiced from across the spectrum – the end outcome is nearly universally considered to be “balanced” – a key objective of modern intellectual property policy. The process and substantive outcome lies in sharp contrast to the conditions of intense secrecy that surrounded the last multilateral agreement on IP to be concluded – the much maligned Anti-counterfeiting Trade Agreement (ACTA) , as well as the most important one currently ongoing – the Trans Pacific Partnership (TPP). (See generally Jeremy Malcolm, Public Interest Representation in Global IP Policy Institutions). And thus it is an appropriate time to question what international IP negotiators in the TPP and elsewhere should learn from the success of WIPO and the failure of ACTA.
An investigation conducted by Edward Hammond, consultant researcher of Third World Network, has revealed that a leading medical centre in The Netherlands is using a material transfer agreement (MTA) that claims proprietary rights over the Middle Eastern Respiratory Syndrome (MERS) virus, contrary to their public denial of placing restrictions on the virus.
Buenos Aires (May 16, 2013).
ALIFAR, the Latin American generic pharmaceutical association, released a press release today announcing that it “decided to collectively support their associations from Chile, Mexico and Peru during TPP negotiations.” The announcement follows a three day meeting in Cartagena de Indias, Colombia. The release recounts that ALIFAR has issued a statement encouraging the Chilean, Mexican and Peruvian Governments “not to accept new and higher IP rights protection and enforcement standards that erode TRIPS’ flexibilities.” The statement continues:
“In that context, ALIFAR will join efforts with those advocacy groups sharing its strategic vision about intellectual property, access to medicines and public health.”
In this year’s Special 301 report, the United States Trade Representative listed Ukraine as a “Priority Foreign Country” (aka PFC), triggering a 30 day countdown to initiate an investigation under Section 301 of the Trade Act to determine trade sanctions. 19 USC 2412(2)(A). This is only the second time that the U.S. has threatened a WTO-member country with sanctions as a PFC. And thus it is an appropriate time to ask what restrictions the World Trade Organization places on the operation of the Special 301 program. As described more fully below, any sanction of Ukraine, including removal of General System of Preferences (GSP) benefits, would likely violate WTO rules. Indeed, the listing of Ukraine as a PFC, and the more general operation of “watch lists” threatening sanctions for intellectual property matters, could be challenged under the WTO even prior to any sanction actually going into effect.
The first Obama campaign for the presidency reached out to access to medicines campaigners to join the broad coalition he was building to gain the presidency. In response to their concerns, he declared that his presidency would “break the stranglehold that a few big drug and insurance companies have on these life-saving drugs,” and pledged support for “the rights of sovereign nations to access quality-assured, low-cost generic medication to meet their pressing public health needs under the WTO’s Declaration on Trade Related Aspects of Intellectual Property Rights (TRIPS).” The Obama administration has now produced five Special 301 reports cataloging its policies on intellectual property and access to medicines. In the first three reports, as detailed below, the administration received low marks on its commitments from public health campaigners.
One of the diverse sources from which the international intellectual property regime emanates is an annual unilateral adjudication of foreign government trade policies by the United States under the so-called “Special 301” program and report. For over two decades the report has functioned as one of the primary sticks for the U.S.’s “carrot and stick” approach to international intellectual property policy. The report weighs countries’ compliance with intellectual property standards and enforcement efforts—both those embedded in existing treaties and those the U.S. would like to see adopted. It threatens and rewards countries via inclusion on or delisting from its annual ‘Watch List’ (“WL”) and ‘Priority Watch List’ (“PWL”), and has the power to implement unilateral trade sanctions when U.S. demands are not met. The construction of the report requires the administration to take decisions on which countries it views as having “adequate” intellectual property protection. The report is thus a key expression of the trade policy of the U.S. in intellectual property matters.
[Shamnad Basheer] Late last year, leading publishing houses including Oxford University Press and Cambridge University Press brought a copyright action against Delhi University and a tiny photocopy shop licensed by it, seeking to restrain them from supplying educational course packs to students. This lawsuit sent shock waves across the academic community, leading more than 300 authors and academics including famed Nobel laureate Professor Amartya Sen to protest this copyright aggression in an open letter to publishers. Tellingly, 33 of the authors of various books mentioned specifically in the lawsuit (as having been copied in the course packs) signed this protest letter making it clear that they were dissociating themselves from this unfortunate lawsuit.