Access to Medicine Ongoing Challenge for Poor

Oxfam has released today a Briefing Paper outlining how very little has changed to improve access to medicines since Doha. In the press release accompanying the publication, Oxfam says, "Poor people in developing countries are still being denied life-saving medicines five years after world leaders signed a formal trade declaration to put health before profits."

The Briefing Paper, entitled "Patents versus Patients: Five years after the Doha Declaration," maintains that trade rules continue to present a major barrier to genuine access to affordable medicines. The Paper describes patent protection as an ongoing obstacle to the delivery of cheaper generic versions to poor countries and calls for urgent action.

The Paper states "The Doha Declaration unequivocally recognises and clarifies that the TRIPS Agreement should not prevent WTO member countries from taking measures to protect public health," and "recognises the legitimate need of countries to take measures to reduce the price of medicines, such as using TRIPS safeguards." However, the "TRIPS-plus agenda" is seriously compromising the availability of such flexibilities and safeguards. In particular, the Briefing Paper criticises US trade policy and the emphasis on bilateral and regional free trade agreements as a way to ensure strong intellectual property protection despite the commitment to public health in the Doha Declaration. This is combined with what the paper describes as the indifference of other rich countries, where "all pharmaceutical companies selling medicines in a developing country, including European countries, benefit ... essentially 'free-riding' on US efforts to introduce TRIPS-plus rules."

The paper calls for new ways to promote patients over patents, noting the World Health Assembly Resolution of 2006 which established the inter-governmental working group. The World Health Organization (WHO) is tomorrow completing a public hearing in preparation for the meeting of the working group. Oxfam's paper focuses on several important cases, including the Glivec controversy.

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) was reported in Reuters today as arguing that access to medicines is not the major public health issue in the developing world, but rather inadaquate infrastructure. But Ellen 't Hoen of Medecins sans Frontieres (MSF) was quoted as saying "The current system based on patents and high prices to pay for innovation leads to rationing and leaves huge health needs neglected."

Oxfam is currently launching the Briefing Paper at BMA House in London, with highlights to be published at Patents vs Patients: Whose Rights Come First?

Lamy Warns Against Bilateral "Disease"

Pascal Lamy has warned that bilateral and regional talks may be an obstacle to a resumption of the Doha Round of negotiations.

Speaking yesterday at "Why Do Companies Care About Europe," organised by the Confederation of European Business (UNICE), the Director-General of the World Trade Organization (WTO) warned that the increased emphasis on regional negotiations and bilateral trade agreements may undermine attempts to resume multilateral negotiations. In an Associated Press report, Lamy is quoted as warning, "All efforts (should be) on getting a multilateral deal. In the case of a failure, the poorest will be hit hardest."

In an address to the International Trade Committee of the European Parliament yesterday, Lamy said that the WTO would try to put more pressure on countries pushing such policies, to re-start the negotiations. Such countries include the US, Australia, Japan, India, Brazil, and of course, the EU. As a report today says, "Mandelson's bilateral plans will harm poor." In his speech, Lamy said that the failure of the trade talks would be like "a slowly developing disease that would progressively sap the strength of the multilateral trading system built up over the past 50 years, damaging its economic lungs, its political heart, and its systemic bone structure."

Lamy will be hosting an online chat today, 16.30-17.30 Geneva time - WTO in Crisis: Which Way Forward?

EU Trade Pacts - UK Calls for Attention to Development

According to a report today in the Financial Times, UK ministers have written to the European Commissioners for Trade and Development urging greater consideration of development issues when pursuing trade pacts with developing countries, ahead of today's trade meeting in Luxembourg. This comes when India and the EU agreed last week to work towards a new bilateral trade and investment deal by 2009.

In an open letter to Louis Michel, EU Commissioner for Development, and Peter Mandelson, EU Commissioner for Trade, the two ministers - Ian McCartney, UK Trade Minister, and Gareth Thomas, Development Minister - have said, "We are concerned about the current state of the negotiations and want to see these agreements deliver real benefits to ACP [Africa, Caribbean and Pacific] countries."

In particular, as seen in yesterday's post, free trade agreements are being criticised as merely obliging developing economies to accept foreign competition and intellectual property laws in ways that may be detrimental to domestic policies and to economic development. Similar issues are raised in the UK letter to the Commission, revitalising the "Singapore Issues" that have been marginalised in international trade talks. The so-called "Singapore Issues" have been seemingly insoluble due to disagreements over vital development concerns, particularly at the World Trade Organization (WTO) 5th Ministerial Conference in Cancun, 2003. Development remained on the agenda at the 6th Ministerial Conference in Hong Kong, 2005, but since the recent collapse of the Doha Round, development issues are increasingly vulnerable to being silenced through bilateral agreements.

In a recent speech at the London School of Economics and Political Science (LSE), Peter Mandelson said that the EU remains committed to sensitive and "deep" free trade agreements. And in a comment in India's Financial Express, Mandelson reiterates his commitment to the "sensitive issues," saying that the EU-India agreement "would have to be deep and substantive ... We also need to improve the enforcement of rules on the protection of intellectual property rights."

But an article in today's Guardian newspaper, suggests that such agreements may not necessarily be sensitive to development. In the article, Angela Balakrishnan refers to the Commission letter leaked last May, which revealed pressure from Peter Mandelson on the UK Prime Minister, Tony Blair, "to take a more moderate line in Britain's pro-poor country approach to trade liberalisation." As Balakrishnan notes, the Commission accused the UK government of being influenced by celebrities and non-governmental organisations (NGO) in its policies.


Or perhaps it's just a campaign of distraction.

FTAs - A Threat to Public Health

Representative Henry Waxman and Senator Edward Kennedy have requested the Government Accountability Office (GAO) to investigate the impact of trade negotiations and policy on public health and access to medicines in developing countries.

In a press release, the request for an investigation of the Administration's trade negotiations is called for in the context of the "negative effects on developing countries' access to medicines." Referring to the Trade Act of 2002 (US Trade Promotion Authority Act), which obliges the government to respect and promote public health in all countries as part of US trade practices and policy. The Trade Act of 2002 grants the US President authority to negotiate bilateral trade deals with other countries, the approval of which is streamlined (fast track authority) with Congress unable to amend such agreements, merely to approve or reject. Such fast track authority was used in Uruguay Round of negotiations leading to the establishment of the World Trade Organization (WTO) and the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Renewed in 2002, the fast track authority will expire in July next year unless extended by Congress.

The letter to the Comptroller General of the GAO refers to the three objectives dealing with intellectual property in the Trade Act of 2002 - IP protection, market access, and public health - and argues that, taken together, these outline the "clear vision for trade negotiations related to intellectual property." Further, "we would like to learn to what extent the third objective, to respect the Doha Declaration on TRIPS and Public Health, has been pursued."

The letter to the Secretary of Health and Human Services, US Department of Health and Human Services, refers specifically to a letter from William R Steiger (pictured at right), HHS Special Assistance for International Affairs, sent to the Acting Director General of the World Health Organization (WHO) insisting upon the withdrawal of the study, "The Use of Flexibilities in TRIPS by Developing Countries: Can They Promote Access to Medicines?" The study, prepared by Sisule Musungu of South Centre and Cecilia Oh of the WHO, criticises the impact of US trade policy on international public health and access to medicines.

The action by the two politicians comes at the same time that the Thai Network of People Living with HIV/AIDS (International HIV/AIDS Alliance Thailand) is campaigning against the Thai-US free trade agreement (FTA) in the US. The campaign was launched earlier this month and will continue until 29 October throughout major US cities. In a recent report in the Bangkok newspaper, "The Nation," Nimit Tienudom, Director of the AIDS Access Foundation described the campaign as informing US citizens about the impact of US trade policy on access to HIV/AIDS treatments. In an earlier article in the same newspaper, Tienudom criticised the Thai-US FTA: "Under the current law and trade agreements we have, there still are ways out such as the compulsory licensing measures ... If we accept the FTA, all doors will be shut."

These are concerns not only in agreements with developing countries, but also in those with countries like Australia. The Australia-US FTA (AUSFTA) has been criticised widely, particularly in the US objection to Australian health policy as a barrier to trade. The Pharmaceutical Benefits Scheme (PBS) is the specific focus of that objection (and is the subject matter of a side letter to the AUSFTA). As a result, public health and medicines were major aspects of the negotiations and of the campaigns both for and against the AUSFTA. Significantly, the imposition of the US economic model in this area of domestic policy was seen seriously undermining government capacity and democratic principles in Australia. Annex 2-C (Pharmaceuticals) to Chapter 2 (National Treatment and Market Access for Goods) establishes a joint Medicines Working Group, which many commentators have criticised as introducing US-style pricing for medicines and undermining public health policies of affordable medicines. Further, Article 17.10 (Measures Related to Certain Regulated Products) and mandating of 5 years data exclusivity may delay access to affordable generic versions of brand-name drugs.

FTAs have also been criticised for rendering traditional and indigenous knowledge increasingly vulnerable to appropriation through the intellectual property protection of the bioprospecting activities of pharmaceutical companies. In particular, the DR-CAFTA has been described in the Latinamerica Press as paving the way for biopiracy, having "opened the door to foreign ownership of the right to exploit the region's abundant and diverse tropical flora."

The international network, bilaterals.org, has just published its very useful background paper, "Overview of Bilateral Free Trade and Investment Agreements." The paper was prepared for the FTA Watch "Fighting FTAs" international strategy workship, held in Bangkok in July this year.

CAFTA - Dominican Pharma Criticises US Demands

The US requirements in the area of pharmaceuticals in the Central American Free Trade Agreement (CAFTA) have been described as "abusive demands" by the Dominican Association of Pharmaceutical Industries (INFADOMI).

In an earlier post, FTAs and Public Health, it was reported that negotiations had been delayed over issues regarding data exclusivity and the new pharmaceutical products. In an article in Dominican Today, the changes to the definition of "new product" are a threat to local industry and are in addition to those already specified in the document. This is despite an earlier story, where Hans Hertell (at left), Ambassador to the US, suggested that the impasse over pharmaceuticals and free trade was close to being resolved, and that there would be no further requirements in addition to the original requirements for implementation.

FTAs and Public Health

The US and Dominican Republic have just missed the 1 October deadline for implementing the Central American Free Trade Agreement (CAFTA). US officials have rejected the most recent draft of the Dominican Republic implementation of the Agreement, on the grounds that the patent laws are insufficient.

Judit Rius Sanjuan, Staff Attorney for the Consumer Project on Technology (CPTech) has reported that according to government and private sector sources, more time is needed to negotiate issues on pharmaceutical patents (as well as other concerns, such as textile rules of origin). An informal extension to 1 November is now believed to be in place, although this is also unlikely to be met.

One of the areas of negotiation in the CAFTA is the protection to be provided by the Dominican Republic for data generated by drug originators for the purposes of marketing approval. Such data indicates the efficacy and safety of the drug, and is important for determining equivalence for generics subsequently entering the market. However, the protection would protect the data under "data exclusivity" provisions in the Agreement. Without marketing approval, a drug cannot enter the market (time on the market therefore running "against the clock" of the patent protection). The CAFTA requires participants to provide 5 years of data exclusivity from the date a pharmaceutical product is submitted for marketing approval (for agricultural chemicals, the period is even longer, at 10 years). These provisions would give originators somewhat extended protection against generics over and above that provided by patent protection, in what is arguably anti-competitive and contrary to innovation in drug development.

Another concern in the agreement is the relationship between patents and marketing approvals. In response to issues surrounding the implementation of the Agreement in Chile, the Pharmaceutical Research and Manufacturers of America (PhRMA) has argued that Chile is giving marketing approval to drugs that are copies of products still under patent. As a result, the United States Trade Representative (USTR) has commenced a Special 301 Out-of-Cycle Review of Chile to monitor its progress on intellectual property protection, citing as a major concern ongoing issues around data exclusivity and the protection of test data submitted by pharmaceutical companies during the approval process.

A recent debate in the Financial Times raises concerns about the impact of free trade deals on competition in the generic drugs market. The article, "Patent or patient?" by Alan Beattie, Andrew Jack, and Amy Kazmin, describes the congressional mandate and "fast-track" trade promotion authority behind "a US drive to strengthen patent enforcement and intellectual property rights protection around the world - a campaign backed by some of the powerful drugs companies." Noting the opposition from public health specialists, campaigners, and developing countries, the article questions the argument that patent protection will bolster innovation.

The authors consider the bilateral negotiations with Thailand and the similar requirements on data exclusivity in the Thailand agreement. In the article, the Deputy Director of Research and Development at Thailand's Government Pharmaceutical Organisation (GPO), Achara Eksaengsri, thinks the bilateral terms would have a highly detrimental impact on public health, particularly in treating HIV/AIDS.

Also in the article, Pedro Chequer, former head of Brazil's national AIDS programme, describes "intense lobbying" and "threats of direct retaliation" when Brazil declared it would issue a compulsory licence to produce Kaletra, a second-line AIDS treatment. Bilateral negotiations may weaken these flexibilities current available.

In a letter to the FT, responding to the article, Kathleen Jaeger, President and CEO of the Generic Pharmaceutical Association (GPhA), says, "The FTAs are establishing a lopsided global system of pharmaceutical IP rights." She goes on to say that this limits generic competition not only overseas, but also in the United States: "The USTR must not leave our healthcare system vulnerable to prolonged brand drug monopolies."

Meanwhile, in Europe, Peter Mandelson, Commissioner for External Trade, has rejected the proposal from Angela Merkel, German Chancellor, for a free-trade area between the EU and the United States. Mandelson argued that such a deal would "trigger an outcry" from the rest of the world.