The generic industry is in trouble again, and the issue is now becoming a major non-tariff barrier against developing countries like India. Two large drug consignments of generic medicines were seized in Netherlands by its customs authorities recently. The drugs, while in transit to Peru, were held at Rotterdam port because they infringed patents in EU. Sources said that recently many essential drugs have been held at European ports on way to Africa or Latin America from India by EU customs for intellectual property infringement or by labelling them 'counterfeits'. India is a source of affordable life saving medicines for many African and developing countries, and companies use the established trading route passing through EU ports for supplying essential medicines to millions across the world, potentially jeopardising the lives of those needing drugs in those countries.
Health equity in economic and trade policies
With regard to The Lancet’s series of articles on the inter-relations between the two policy spheres of trade and health, the author of this paper expresses his disappointment with the hazy direction and lack of leadership of the global governance in addressing inadequate access to essential medicines for the poorest population as a result of market exclusivity and patent protection, rendering statements and declarations made by heads of states and leaders of international organisations as rhetoric. The paper draws this conclusion from lessons learned from the experience of compulsory licensing in Thailand and the management of disptutes between Thailand and patent-holding companies and their parent-country governments.
The World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. The question of whether TRIPS generated gains for developing countries, in the form of increased exports, is addressed in this paper. The authors consider the importance of pharmaceuticals in health-care trade, outlining the essential requirements, implications, and issues related to TRIPS, and TRIPS-plus, in which increased restrictions are imposed as part of bilateral free-trade agreements. TRIPS has not generated substantial gains for developing countries, but has further increased pharmaceutical trade in developed countries. The unequal trade between developed and developing countries (ie, exporting and importing high-value patented drugs, respectively) raises the issue of access to medicines, which is exacerbated by TRIPS-plus provisions, although many countries have not even enacted provision for TRIPS flexibilities. The paper focuses on options that are available to the health community to advance negotiations to their advantage under TRIPS, and within the presence of TRIPS-plus.
Developing countries have voiced concerns at a meeting of the Executive Board of the World Health Organization (WHO) over the Secretariat using the term ‘counterfeit’ to describe problems relating to the quality, safety and efficacy of medical products, and addressing such problems through the International Medical Products Anti-Counterfeit Taskforce (IMPACT). Some countries felt the WHO's anti-counterfeit taskforce, IMPACT, was unsuited to address the issue of quality, safety and efficacy (QSE) of medical products because it lacked a mandate from the WHO's governing bodies; and because of its emphasis on counterfeits; the involvement of the private sector in its activities raising issues of conflict of interest; and its lack of transparency.’
Kenya, the third-biggest African market for Indian medicines, is planning a new legislation against ‘counterfeiting’ that could seriously jeopardise India’s medicine exports to that country. Domestic industry fears that other African nations may follow suit. The Anti-Counterfeit Bill, 2008, placed before the Kenyan parliament recently, indicates that copies or generic versions of all products having patent protection in Kenya or elsewhere can be considered ‘counterfeit’ in case of an intellectual property dispute. Since a majority of medicines manufactured by Indian companies are under patent protection in some country or the other (though they do not enjoy patent protection in India or Kenya), the definition, in its current form, can be misused to delay or prevent supply of low-cost generic medicines to Kenya, industry experts fear.
The Global Call to Action Against Poverty (GCAP) has urged every government attending Doha to reform the global economic system in more democratic forums so the people affected by poverty have a full and equal say. A new financial architecture must deal with global imbalances, the need for government regulation and interventions for each developing country. GCAP was represented at the Financing for Development meeting in Doha by members of the Feminist Taskforce and Arab region, African, Asian and European coalition members and co-chairs. The long-term solution to the financial crisis requires much more than re-establishing rich countries’ economies and bailing out banks. The world needs solutions for a new financial and trade architecture that could provide for the poor and often voiceless people in the world.
The top executives of the World Bank and the International Monetary Fund (IMF) – both Bretton Woods Institutions – have decided not to attend the much-vaunted UN-sponsored Doha conference on Financing for Development. The decision is all the more startling because there remains a clear need for a swift and broad-based response to the financial crisis. By failing to attend the summit, both institutions certainly undermine their claims to leadership. Some observers have interpreted this as a show of contempt for the issues the poorest countries – especially those who did not participate in the G20 Summit on November 15 – may raise about international financial reform. Their conspicuous absence is typical of an approach that favours elitism and ‘club-based’ decision-making over inclusive processes.
This paper seeks to explain the policy-based lending progamme of the World Bank (WB), and the significance of its engagement with developing economies, Africa in particular. The authors find that the Bank, through its policy-based lending, dictates key policies to borrowing countries, thus eroding their autonomous police space and their ability to evolve economic policies best suited to their particular ecologies and peculiar circumstances. The risk of incurring the wrath of the Bank – which will make it to declare such a country non-creditworthy – is often too much for borrowing countries to bear. Clearly, a new model of development will have to emerge from popular political and class struggles at all levels of national and international communities, including the African Union (AU) and the enlarged G77.
This new book provides extensive evidence and data in accessible format for researchers and policymakers in the field of intellectual property rights and gives background information on the origins of the TRIPS Agreement for readers new to the subject. For scholars of international political economy and law, it is the first detailed exploration of the links between global IP politics and the implementation of IP reforms. It exposes how power politics occur not just within global trade talks but afterwards when countries implement agreements. The Implementation Game will be of interest to all those engaged in debates on the global governance of trade and intellectual property.
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.