Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Commitment to conclude ACTA in 2010 reaffirmed in latest negotiations

This article was originally published in SRA

Participants at the sixth round of negotiations on the proposed Anti-Counterfeiting Trade Agreement reaffirmed their commitment to work towards concluding the agreement as soon as possible in 2010, according to a statement by the Office of the US Trade Representative1.

Participants in the negotiations, which took place in Seoul, South Korea, on 4-6 November, included Australia, Canada, the European Union (represented by the European Commission, the EU presidency (Sweden) and EU member states), Japan, Korea, Mexico, Morocco, New Zealand, Singapore, Switzerland and the US.

According to the USTR statement, the latest round of negotiations underlined the importance of ACTA in providing an enhanced framework to fight global infringement of intellectual property rights, particularly in the context of counterfeiting and piracy. Discussions focused on enforcement of rights in the digital environment and criminal enforcement.

Participants also discussed the importance of transparency including the availability of opportunities for stakeholders and the public in general to provide meaningful input into the negotiating process.

Pressure for transparency

The lack of openness surrounding ACTA has long been an issue of concern among public interest groups, which have maintained their pressure for transparency in the process. On 5 November, 16 library, consumers, creator and civil organisations wrote to President Barack Obama to protest against the US Administration’s secrecy on the new trade agreement which, they contend, conflicts with the President’s promise of a more transparent, collaborative and participatory government2.

The USTR has repeatedly declined to make public the draft text of the agreement, says the letter. [Public release of a select part of the document by the USTR earlier this year was criticised for its lack of substantive information3.] While the groups appreciate the USTR’s efforts to broaden access to the draft section and to solicit a range of views, “the modest increase in stakeholder participation is no replacement for true transparency and civic engagement”.

Whereas confidentiality may be appropriate in negotiating traditional trade matters such as tariffs and trade barriers, the groups say that “attempts to force a multilateral intellectual property agreement through trade processes unsuited to it does a disservice to citizens, public policy, and the USTR alike”.

“Anti-consumer” concerns

In a separate letter sent to US congressional leaders on 9 November, two of the most active organisations in the debate over the proposed ACTA addressed concerns related to the substance of the agreement4. Knowledge Ecology International and Public Knowledge say that based on what is known about the negotiation from public press reports and “credible leaked documents”, it appears that the ACTA negotiators “are seeking to create a set of obligations for countries that expand upon certain elements of the World Trade Organization’s Trade Related Aspects of Intellectual Property (TRIPS) agreement”.

“It would seem,” state KEI and Public Knowledge, “that the ACTA negotiators have identified certain parts of the TRIPS agreement most favourable to particular groups of intellectual property holders”, including pharmaceutical companies.

The public interest groups are concerned about the apparent exclusion from ACTA of safeguard provisions embodied in TRIPS that are favourable to consumers. Among provisions they identify is Article 44.2 of TRIPS, which allows governments to eliminate the possibility of injunctions to enforce intellectual property rights in certain cases where governments provide for remuneration to rights owners. If the ACTA discards the flexibility found in this provision, KEI and Public Knowledge claim that certain sections of US law that are important to consumers would be at risk.

As an example, they highlight the relevance of the treatment of injunctions in the ACTA to the use of patents by medical practitioners, the safe harbour infringement exception for general medicines and for the ability of the US to acquire generic medicines for use in the President’s Emergency Plan for AIDS Relief programme, when goods are shipped as “goods in transit” through countries with different intellectual property regimes and registered rights.

The letter to Congress concludes: “The ACTA negotiations, while operating in extraordinary secrecy, are leading to a result that is anti-consumer and anti-innovation… [They] should be made open, or they should be stopped.”

The next ACTA meeting will be hosted by Mexico in January 20105.

References

1. USTR press release, 10 November 2009, www.ustr.gov:80/about-us/press-office/press-releases/2009/november/-office-us-trade-representative-releases-statemen

2. Letter to President Obama, 5 November 2009, www.publicknowledge.org/pdf/acta-letter-20091105.pdf

3. The Regulatory Affairs Journal – Pharma, 2009, 20(6), 375-376

4. Letter to Congress, 9 November 2009, www.publicknowledge.org/node/275

5. Swedish Presidency of the EU, press release, 6 November 2009, www.se2009.eu/en/meetings_news/2009/11/6/the_6th_round_of_negotiations_on_anti-counterfeiting_trade_agreement

Latest Headlines
See All
UsernamePublicRestriction

Register

PS114813

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel