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Summarised by Vasudha Reddy, Intern, Centad
Some recent international events on generic drug seizures and anti-counterfeiting campaigns have taken India by surprise. In a recent address by India's Commerce Secretary Mr. G K. Pillai to their excellencies Ambassadors from African Countries, the Government's strong disapproval of high-handedness of developed countries on issues at the core of health care is appreciable. It is expected that the Indian Government will take up these matters at appropriate forums and register its protest with the same tenor. Suitable remedial measures, including a challenge at the WTO Dispute Settlement Body must be explored on priority basis.
Centad has been at the forefront of informed discussion, research and advocacy on issues that can have tremendous impact on trade and public health. It has been supportive of low-cost and safe generic drug availability to further the cause of universal access to health care.
A brief summary of the Commerce Secretary's speech is produced herewith........
The Commerce Secretary began by recounting two important incidents that had recently taken place. The first concerned the repeated seizure and detention of generic pharmaceutical products by customs authorities in Europe, particularly those in the Netherlands. The second was with reference to some recent and ongoing attempts to conflate issues of alleged intellectual property (IPR) violations with drug quality and safety.
On the issue of seizure of generic drug consignments, the Secretary noted that these products were being exported from India to nations in Africa and Latin America, including Brazil, in all of which they did not receive patent protection. However, they were targeted by customs authorities on the grounds that they were patent-protected in Europe and therefore, infringed upon the rights of patent-holders there. This was in spite of the absence of any evidence that the products would be diverted towards European markets. Freedom of transit for legitimate trade is clearly laid down under GATT. The TRIPS Agreement also emphasizes that measures to protect intellectual property should not pose barriers to legitimate trade. The Secretary explained that India and Brazil had taken up the matter with the European Commission and the World Trade Organization, clearly pointing out the illegality of the European measures dealing with border enforcement. Another important incident having far-reaching consequences on healthcare needs of African countries was the detention in the Netherlands of anti-AIDS drugs being sent from India to Nigeria on the grounds that they were patent-infringing. The Secretary stated that India was preparing to take the matter to the WTO dispute settlement body.
He explained that TRIPS had originally reflected the concerns of developed nations, particularly their pharmaceutical industries, for the protection of their investments. It was only after sustained efforts by developing nations that certain flexibilities were added to the Agreement. These included a longer transition period in which the TRIPS regime for product patents was to be implemented in least developed countries, limited exceptions to patent rights as well as provisions allowing compulsory licenses and parallel imports.
The Secretary contended that generic consignments from India were being targeted because of the latter’s strong position as a producer and exporter of generic drugs that were far less expensive than their patent-protected counterparts. This had huge implications for the healthcare needs of developing countries. He believed that the incidents in Europe were part of a larger plan to ensure that intellectual property rights (IPRs) were stringently upheld even at the cost of the public health concerns of developing countries.
The second issue that the Secretary brought up was regarding the introduction of anti-counterfeiting legislations in a number of African countries, which allow for the enforcement of IPRs even on products that are not patented in such countries. Explaining the overreaching implications of a recent Kenyan legislation, the Secretary took the example of a pharmaceutical product that is registered for patent-protection in Jordan, but not in India or Kenya. Under the Kenyan law, he explained, a generic version of this drug exported from India to Kenya could have legal action taken against it by the African nation. The Secretary asserted that such legislations went beyond the requirements of TRIPS, especially the principle of territoriality, as per which a right is enforceable within the territory in which a patent has been registered.
The Secretary took note of the Doha Declaration of 2001, according to which members may grant compulsory licenses for exporting medicines to countries that lack manufacturing facilities. He emphasized that this provision would be rendered meaningless if African nations enacted laws that restricted legitimate trade in generic medicines. The Secretary also pointed out that the Doha Declaration stated that the TRIPS “Agreement can and should be interpreted and implemented in a manner supportive of WTO members’ right to protect public health and, in particular, to promote access to medicines for all.”
Next, the Secretary drew attention to the efforts of multinational pharmaceutical companies backed by the developed nations like the USA, the EC and Japan to protect and enforce IPRs in a maximalist manner, thus skewing the balance between IPRs and public policy objectives in favour of the former. He pointed out that this was taking place in a number of international fora like the World Customs Organization, the World Health Organization and the Universal Postal Organization etc. He also noted with dismay the efforts by some WTO members to push for TRIPS-plus provisions on issues such as patent term extension, data exclusivity and the limitation of grounds for compulsory licenses etc. which were increasingly being included in regional trade agreements. He termed this to be subtle way to circumscribe the flexibilities in TRIPS, which otherwise allow developing countries to safeguard their public health interests.
The Secretary highlighted the magnitude of public health issues in the Indian sub-continent and Africa, pointing out the close relationship in these regions between poverty and health. He explained that both regions had to address water-borne diseases, respiratory diseases with environmental triggers, the effect of malnutrition, tuberculosis, malaria and most importantly, HIV/AIDS. All of these diseases, he contended, involve prolonged treatment and take place on an immensely large scale. He stressed upon the dangers of an IPR-maximalist system, painting a picture of a market in which only branded and patent-protected medicines are allowed and generics are not, thus creating total dependency on a small group of multinationals and causing a tremendous rise in the costs involved.
The Secretary then addressed the highly misunderstood notion that generic drugs are of poor quality. He distinguished between spurious drugs and counterfeit ones, identifying the former as sub-standard and constituting a public health issue while the latter merely involved an issue of IPRs. The Secretary took pains to emphasize that counterfeit issues relating to alleged IPR violations were entirely different from issues of production and sale of spurious drugs. He stressed India’s commitment to manufacturing safe, high-quality drugs, pointing out that after the USA, India had the largest number of USFDA-approved manufacturing plants. This amply proves India’s commitment to the production and trade in good quality drugs, perhaps, the best in the world.
The Secretary asserted such unfair efforts against developing countries must be tackled on a war footing basis so as to prevent a new form of dependence by developing nations on developed ones. He concluded by reiterating India’s willingness to provide any assistance required by Africa in this direction, including the setting up of manufacturing plants, undertaking capacity development, and any other assistance which is necessary for African Governments to understand the importance of generic medicines in their public healthcare obligations.
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