On 19 September, the World Health Organization released a new report that reaffirms the world is running out of antibiotics to fight key and deadly infections due to the fast pace of resistance by bacteria and the lack of new antibiotics to replace or supplement the existing antibiotics. Most new drugs in the pipeline are only modifications of existing classes of antibiotics and are short term solutions, says the WHO. And there are very few potential treatment options for antibiotic resistant infections causing the greatest health threats including resistant TB. This article by TWN explore the issue and the level of (under)investment in new treatments. It argues further for improved infection prevention and control and for fostering appropriate use of existing and future antibiotics.
Health equity in economic and trade policies
"We denounce the unsustainable situation of debt in poor countries of the world, and the coercive use by governments, multinational corporations and international financial institutions. We strongly demand the total and unconditional cancellation and rejection of the illegitimate debts of the Third World. As a preliminary condition for the satisfaction of the fundamental economic, social, cultural and political rights, we also demand the restitution of the longstanding plunder of the Third World. We especially support the struggle of the African peoples and their social movements. Once again we raise our voices against the G8 Summit and the meetings of the IMF and World Bank, who bear the greatest responsibility for the plunder of entire communities. We reject the imposition of regional and bilateral free-trade agreements such as FTAA, NAFTA, CAFTA, AGOA, NEPAD, Euro-Med, AFTA and ASEAN."
This report examines the range of contingency measures available in trade agreements and the role that these measures play. These measures allow governments a certain degree of flexibility within their trade commitments and can be used to address circumstances that could not have been foreseen when a trade commitment was made. The tension between credible commitments and flexibility is often close to the surface during trade negotiations. One of the main objectives of this report is to analyse whether the World Trade Organization (WTO) provisions provide a balance between supplying governments with necessary flexibility to face difficult economic situations and adequately defining them in a way that limits their use for protectionist purposes. The report also discusses alternative policy options, including the renegotiation of tariff commitments, the use of export taxes, and increases in tariffs up to their legal maximum ceiling or binding.
Confronted with longstanding assertions that World Trade Organization rules intended to bring greater access to medicines to poor countries are not working, WTO Director General Pascal Lamy said discontented members should use the annual review of those rules if they have a complaint. In August 2003, the WTO General Council called for a resolution to the problem of countries lacking pharmaceutical manufacturing capabilities but who need to obtain cheaper medicines through a compulsory license. They created a waiver to the WTO rule that products manufactured under compulsory license must be substantially all for the domestic market. Only Rwanda has so far used the Paragraph 6 process and Lamy said no country had raised any significant concern in the annual review. But an official at the speech questioned the validity of the review process and suggested that no real review had taken place. Health activists have repeatedly said the waiver is too cumbersome to be useful and effective.
The TRIPS Council of the World Trade Organisation (WTO) decided on 11 June 2013 to allow Least Developed Countries (LDCs) to delay implementation of the TRIPS Agreement until 1 July 2021. At the end of this period, LDCs can request further extension. The terms of the June 2013 decision this time are better than the terms in the previous extension, granted in 2005, says South Centre. This is attributed to the determination and skill of the LDC Group, led by Nepal, during month long negotiations between the LDC Group and developed country members of the WTO. The new extension period is for eight years, starting on 1 July 2013. This is longer than the seven and a half years transition period provided in the 2005 decision. It is also significantly below what the LDC Group had asked for in its formal proposal IP/C/W/583, in which the Group had requested that the transition period should last so long as the country remains an LDC. The 11 June 2013 decision has also removed the condition introduced in the earlier 2005 decision that LDCs cannot roll-back the level of implementation of the TRIPS agreement that they have already undertaken in their national legislation.
Access to medicines in developing countries may be put at risk by European customs regulations and more broadly by trade provisions in most free trade agreements between developed and developing countries, said speakers at the recent World Trade Organization (WTO) Public Forum, held from 28–30 September. European Union (EU) regulation 1383/2003 concerning customs action against goods suspected of IP infringement is open to interpretation, said Sunjay Sudhir, counsellor at the Permanent Mission of India. There are fears that decisions taken under regulation 1383/2003 reflects a larger design for tougher enforcement of IP rights, part of which is a campaign of deliberately confusing quality concerns with IP rights in international organisations. The issue has arisen in the World Health Organization, and can be noticed in TRIPS-plus elements in bilateral free trade agreements, and the Anti-Counterfeiting Trade Agreement (ACTA) under negotiation to the exclusion of many countries, including developing and least-developed countries, according to Sudhir. ‘Regulation 1383/2003 should be reviewed and brought into line with TRIPS, GATT, and the Doha Declaration on the TRIPS agreement and public health,’ he recommended.
Paragraph 6 – the first and only amendment to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) – allows Ministers to alter the TRIPS agreement so that developing countries can use compulsory licences to manufacture generic medicines exclusively for export to countries unable to make them themselves. Countries have not all ratified the amendment. On 30 November 2011, the World Trade Organisation (WTO) General Council agreed to extend the deadline for countries to adopt the amendment at national level from December 2011 to 31 December 2013. Two-thirds of the WTO membership (i.e. 102) must ratify the change for it to go into effect. By November 2011 only 39 countries had done so. There has been much discussion about whether the ‘Paragraph 6 solution’ has been effective, as after eight years it has only been used by Canada and Rwanda. Countries have raised that the process is too cumbersome.
In the World Trade Organization intellectual property committee meeting in February, least-developed countries (LDCs) submitted a request to extend a waiver allowing them not to enforce intellectual property rights on pharmaceutical products that goes to 2016. The countries have extended the waiver before, but this time they are seeking to make it indefinite, until they are no longer considered LDCs are disproportionately exposed to the health risks associated with poverty, and “patent protection contributes to high costs, placing many critical treatments outside the reach of LDCs, according to a communication by the group.
MSF is concerned that further proliferation of so-called 'TRIPS plus' provisions in free trade agreeements negotiated by the United States may jeopardise the progress that has been made on access to medicines. This may have enormous consequences for the health and life of millions of people, says MSF, and this is particularly so given the deadline of 1st January 2005 after which pharmaceutical product patent protection has to be provided by all non-Least Developing Country Members. MSF says in a letter to EU Trade Commissioner Pascal Lamy that the adequate protection of public health demands that WTO Members be permitted to give full effect to the letter and spirit of the Doha Declaration on TRIPS and Public Health (“Doha Declaration”) in their domestic and/or regional legislation.
A waiver to World Trade Organization (WTO) rules intended to aid people in poor countries in gaining access to medicines is reported to have remained essentially unused in the over six-and-a-half years since it was put in place. Member states of the WTO will be holding an informal meeting to discuss this situation and see what, if anything, needs be done. The 2003 waiver was made an amendment in 2005 within the WTO Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement to allow for increased export of medicines made under compulsory licences. This was intended to give a helping hand to nations without a domestic pharmaceutical industry, who might have public health needs for a patented and unaffordable medicine they are unable to produce themselves.
Under TRIPS, compulsory licences are meant to primarily serve a national market, but the TRIPS public health amendment (often referred to as the ‘paragraph 6’ solution referring to the Doha Declaration on TRIPS and Public Health) allows countries with pharmaceutical industries to manufacture and export more medicines under a compulsory licence to countries without them, provided certain conditions are met.