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Holding position

Europe has accepted the TRIPS protocol but there will be no change for two years

At the end of November 2007, after some political wrangling between the European Parliament, the Council and the Commission, EU Ministers finally accepted the protocol to the World Trade Organisation, Trade Related Aspects of Intellectual Property (TRIPS) agreement.

"The World Trade Organisation is still holding out for an elusive two-thirds endorsement of the amendment"

The protocol will allow World Trade Organisation (WTO) Member States, that have little or no domestic pharmaceutical manufacturing capacity, to import generic versions of patented drugs using a compulsory licence.

PERMANENT WAIVER?
The protocol was written in 2005 to help those countries that do not have drug making capacity. It will directly transform the 2003 'waiver' into a permanent amendment when two-thirds of the 151 WTO members (of which the EU is one) formally accept it. The original deadline was December 31 2007 but this was extended for two years in late October because only 11 Member States had signed up to the new amendment (three other members have signed up since). This means the 2003 waiver remains in place. The WTO is still holding out for an elusive two-thirds endorsement of the amendment. The EU showed its cards on the issue just days before the extension was granted, but don't be fooled into thinking the decision was easily made for the EU. The fraught negotiations between the European institutions meant this decision went to the wire and the required political muscle was stretched to its limit.

EVENTUAL APPROVAL
The amendment was approved by the European Parliament on October 24 2007. The vote had been postponed three times because MEPs were pushing for commitments in intellectual property, overseas aid and R&D. The Commission wanted to include intellectual property in the on-going Economic Partnership Agreements (EPAs) - which would go beyond the provisions of TRIPS. Some MEPs found this unacceptable.

"The potential implications of this amendment will be stalled for a little while longer as the waiver stays - for now"

PRESIDENT'S PROMISE
It took a written commitment that the EU would back down on the issue of intellectual property from José Sócrates - the Portuguese President of the Council of Ministers - and from the Commission, before the Parliament's international trade committee would ratify the amendment. The European Parliament issued its assent a few days later. The Council subsequently adopted the decision on November 19 2007. The President confirmed: "The EU is not seeking and does not plan to seek to negotiate provisions on pharmaceuticals affecting public health and access to drugs". UK Trade Commissioner, Peter Mandelson, said that, "in EPAs and in other future and bilateral agreements with poor developing countries, the commission will not ask for provisions which could affect access to medicines or undermine the TRIPS flexibilities".

NO CHANGE YET
So, after all these political gymnastics, Europe added its name to the other WTO members that have agreed to accept the protocol only to find itself in a holding pattern for two more years. The waiver stays put and nothing much has changed. The big pharma companies can let out a sigh of relief. The potential implications of this amendment will be stalled for a little while longer as the waiver stays - for now. Even if the WTO garners ratification from two-thirds of its 139 members by December 2009, each Member State must amend its domestic law accordingly. To date, only Canada has done this.

"Pharma has been given a life-line of two more years to set out its position on intellectual property rights"

MEMBER STATES THAT HAVE ACCEPTED TRIPS AMENDMENT

UNITED STATES

DECEMBER 17 2005

SWITZERLAND

SEPTEMBER 13 2006

EL SALVADOR

SEPTEMBER 19 2006

REPUBLIC OF KOREA

JANUARY 24 2007

NORWAY

FEBRUARY 5 2007

INDIA

MARCH 26 2007

PHILIPPINES

MARCH 30 2007

ISRAEL

AUGUST 10 2007

JAPAN

AUGUST 31 2007

AUSTRALIA

SEPTEMBER 12 2007

SINGAPORE

SEPTEMBER 28 2007

HONG KONG, CHINA

NOVEMBER 27 2007

CHINA

NOVERMBER 28 2007

EUROPEAN COMMUNITIES

NOVEMBER 30 2007

THE CANADIAN WAY
Canadian legislation has provisions intended to protect the rights of the patent holder before a compulsory licence is issued. Reasonable terms and conditions, such as royalities that relate to the UN Development Index, are to be agreed with the generic manufacturer. In October 2007, Canada authorised domestic generic manufacturer, Apotex, to produce and export a copy-cat version of TriAvir, called Apo-triAvir. This is now being exported to Rwanda, and is the first example of how this protocol could be further rolled out if it were made a permanent amendment to TRIPS by 2009.

TWO MORE YEARS
The debate will rumble on for two more years. Poor countries holding out for the amendment to TRIPS so that they can import generic versions of medicines desperately needed to tackle diseases such as HIV/AIDS will have to rely on the waiver agreement. The pharmaceutical industry has been given a life-line of two more years to set out its position on intellectual property rights more robustly and to communicate this with relevant stakeholders. This has also provided an opportunity for the industry to try and seek clarification of what is meant by 'poor' nations and to ensure this amendment is only applied to low-income countries.

ACCESS TO MEDICINES
The patent protection issue is only one wheel in the cog driving for better access to medicines. The fight to make therapies available to patients has not been put on hold. There are many drugs with non-enforcement commitments in Africa but they are still not getting to patients. Improvements in health systems and in the transparency of the drug supply chain need to be firmly focused on the present. This requires engagement by pharmaceutical companies and other stakeholders. It looks like the pharmaceutical industry still has much work to do over the next few years.

The Author
Kate Brightwell

19th February 2008

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