Medicines Access Again Captures Attention At WTO As Progress Urged In Round

Access to medicine and preservation of biodiversity topped the agenda at the World Trade Organization Trade-Related Aspects of Intellectual Property Rights Council meeting this week, as a new alleged drug seizure in France, a concern over a largely-unused amendment to TRIPS intended to help developing countries gain access to medicine, and a renewed mandate on biodiversity at the World Intellectual Property Organization influenced the issues on the table.

Meanwhile, WTO Director General Pascal Lamy last week called for “intensified, text-based” negotiations in order to make tangible progress on the long-stalled Doha Round of trade liberalisation talks. Industry representatives from the US Chamber of Commerce and the National Foreign Trade Council have been meeting with high-level negotiators and secretariat members in Geneva on the past weeks to encourage a completion of the Doha round.

And at a special session on establishing an international register for geographical indications on wines and spirits, WTO members continued to answer technical questions on particulars of opposing register proposals. The TRIPS Council met 27-28 October. TRIPS Special Sessions were held 23 and 28 October. An informal document outlining special sessions positions is available here [pdf].

The next WTO ministerial meeting, at which a conclusion to the round is explicitly not expected, is from 30 November to 2 December. [Update: Whether to extend a moratorium on non-violation complaints (that is, cases arising even when a TRIPS rule has not been violated) will likely be an issue in the lead up to this ministerial, according to a WTO official. The moratorium traditionally is renewed at ministerial meetings; the US and Switzerland have said the moratorium should expire, the official said.]

A Question of What IP Is and Should Be

A shipment of generic drugs allegedly stopped in a Parisian airport on grounds of patent violation reignited Wednesday a debate over medicines in transit that has been simmering since the beginning of the year. The medicines – 1.74 million tablets of an antiplatelet drug, used to treat patients at risk of strokes and heart attacks due to blood clots – were en route to Venezuela from Mumbai when stopped. India said it received a letter from French customs authorities about the seizure.

A Freedom-Of-Information Act request revealing news of 17 delayed shipments of generic medicines in Dutch ports in 2008 alarmed countries earlier this year, and sparked questions about “systemic” problems in a European regulation on customs authority to handle goods suspected of being counterfeit (IPW, WTO, 9 June 2009).

European delegates at the time said the regulation – EC 1383/2003 – was intended to guard against dangerous drugs, and in an explanatory note [pdf] from 31 July quote the European Federation of Pharmaceutical Industries and Associations saying it is not the policy of their members to “use the powers of detention … to prevent the flow of legitimate generics.”

But India said Wednesday in a statement “we see no guarantee that there will be no seizures of generic drug consignments in the future as long as Regulation 1383/2003 [which allows customs agents to stop goods suspected of any IP infringement, not just trademark infringement] exists in its present form.”

At issue is the question of differing perceptions on what intellectual property is and should be, the delegation of China said in the TRIPS Council meeting Wednesday, one source told Intellectual Property Watch. For some, the source said, the stopped shipments are merely a trade issue, but for others it is an issue of access to medicines.

“Underlying the drug seizures is also a deliberate mixing up of the issue of spurious/sub-standard drugs … with IPRs,” said the statement of India made during the Council meeting. The conflation of counterfeit (seen as an IP matter) with sub-standard medicines (seen as a drug regulatory issue) and also with legitimate generic medicines has been an area of concern for many developing countries, both at the WTO and within the World Health Organization (IPW, WHO, 27 January 2009).

A European delegate told Intellectual Property Watch that the European Communities did not know about the French case prior to the statement of India during the meeting, but that it had taken “several steps to ensure that generics [are] not stopped.”

However, the delegate added, “We cannot create a category of exemption from customs” examination for medicines, and said that the concern over drug delays was an “over-exploitation” of “a few isolated cases in 2008” out of thousands of shipments that pass through Europe.

If the delays were really a problem of regulation EC 1383/2003, then medicines would have been stopped in all countries, not one, and since 2003 when the regulation was passed, as opposed to 2008, the European delegate said. This did not take into account the recently reported Parisian seizures, nor a case in Frankfurt from May (IPW, WTO, 5 June 2009).

However, the European delegate added, the EU is undertaking a review [pdf] of the regulation and remains open to change if it turns out there are problems in need of regulatory solutions.

A representative of India said that this review mechanism – built into the 2003 regulation – started in September 2008, before countries had raised the issue of the seizures, and is focussed on reviewing the regulation in relation to other EU laws, and not to international obligations under TRIPS or the Doha Declaration on Public Health. It therefore does not constitute a response to countries’ concerns, the delegate said.

The European delegate said that the stopped shipments should not be considered seizures, as that implies they were not returned. But the Indian delegate said that delays are barriers to legitimate trade, as both the delays themselves and the necessity of finding other routes to ship pile on costs.

Expeditious Solution to Medicines Access Proves Not So

A 2005 amendment to TRIPS intended to aid developing countries lacking medicine manufacturing capacity is widely perceived as not living up to expectations, with only one use since its inception in 2003 – by a company that has vowed never to use the system again (IPW, IP Burble, 17 September 2009). The amendment allows the export of the majority of medicines produced under compulsory licence.

This “‘expeditious solution’ to the crisis in access to medicines … has been far from expeditious,” said a statement of India made 27 October, which then called for informal consultations with interested members to increase the system’s efficacy.

The African Group also made a statement about the inefficacy of the system, as did the Least Developed Countries group, according to sources.

The US initially opposed informal consultations, an Indian delegate told Intellectual Property Watch, suggesting that the number of times a compulsory licence has been used is not indication of success, and suggesting also that the donations of medicines to developing countries pre-empted the need for the system. They did in the end agree to have one meeting, so long as it is discussions only and with no report, the delegate added.

“We look forward to participating in such discussions,” the US told Intellectual Property Watch, adding “we wanted to make sure that the decision to consult did not presuppose any particular conclusion to the discussion.”

Biodiversity: At WIPO or WTO?

Statements during the past week’s meetings did not reveal changes in positions on three TRIPS issues – one on biodiversity and two on geographical indications – that have been strategically linked by a majority of WTO member states seeking negotiations on them (IPW, 24 July 2009).

However, a new mandate on the protection of traditional knowledge at WIPO was referenced during the discussions, with some countries – Australia, Canada, and New Zealand, according to several sources – citing the new, stronger mandate of the WIPO Intergovernmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore (IGC) (IPW, WIPO, 3 October 2009) in suggesting discussion on IP and biodiversity issues be moved to the UN agency.

Furthermore, the IGC may have its strongest mandate yet, but it is not yet clear whether the “international legal instrument” it has been tasked with creating will be equivalent to the legally binding nature of a TRIPS amendment. The WTO has a dispute settlement mechanism where members can seek redress for non-compliance with its agreements. One supporter of the TRIPS issues linkage said the mandate to discuss biodiversity issues is at the WTO and “should not be outsourced.”