Swine Flu, Public Health and importance of Doha Declaration

Present pandemic fear of swine flu highlights the importance of access to essential medicine to safeguard the public health of people. As the virus keeps spreading around the world, with new cases confirmed in Europe and Asia, the risk is becoming higher.

By Lila Dhar Adhikari

One of the major areas of WTO negotiation is trade related intellectual property rights (TRIPS). Where developed countries and developing countries have different prospects and it is quite obvious that the intellectual property right (IPR) protection brings more benefits to the countries having more patents. Intellectual property rights can be defined as the rights given to people over the creations of their minds. They usually give the creator an exclusive right over the use of his/her creations for a certain period of time, for example, for patent, an exclusive right is granted to a patentee for 20 years after filing the patent application. Intellectual property rights are traditionally divided into two main categories: copyright and industrial property. The former covers creative works such as paintings, books and music. The latter includes intellectual property closely related to industrial creations such as trademark, patent, industrial design, and others.

Patent is the most important intellectual property right which is granted in the invention that is novel, not obvious to those in the field, and useful. For example, new application in mobile, the new technology in saving energy, the new medicine of HIV treatment, the effective vaccine against bird flu, new medicine to treat swine flu can be registered as a patent. The invention of life-saving drugs is more useful as those drugs safeguard the human life. Usually, these inventions are expensive and time consuming as the process needs the prolonged period of hectic research and development activities.

Pfizer and other big pharmaceutical companies invest millions of dollar to bring new drug in the market so they were organised very strongly during the Uruguay Round negotiation and were able to include patent protection for the drugs in the TRIPS agreement. The TRIPS Agreement requires members to comply with certain minimum standards for the protection of intellectual property rights covered in it, pharmaceutical patent is being one of them. Perhaps the most widely discussed TRIPS related issue was the debate over the impact of the agreement on efforts to improve public health in the developing world. When the Uruguay Round was launched in 1986, more than 50 countries did not confer patent protection on pharmaceuticals (UNCTAD 1996).

To address the concern of developing countries on public health issue, the TRIPS Agreement article 31 allows compulsory licensing that permit the production of drugs without the patent holder’s authorisation in return for some compensation to the patent holder.

But the TRIPS Agreement was unclear for the many developing countries to exercise the flexibility provided to them for the public health. Many people were dying because they had no access of essential medicine for HIV. For example, 95 percent of those infected with HIV lived in developing countries and until few years ago, fewer than 5 percent received the anti-retroviral treatment. The joint efforts of NGOs, civil society and the developing countries to get relief from the expensive patented drug such as drugs for HIV/ AIDS, Malaria brought some results which led to the “Doha Declaration on Public Health” which confirms that countries are free to determine the grounds for granting compulsory licences.

The TRIPS Agreement does not specifically list the reasons that might be used to justify compulsory licensing. However, there are a number of conditions aimed at protecting the legitimate interests of the right holder. For example, the person or company applying for a license must have first attempted, unsuccessfully, to obtain a voluntary license from the right holder on reasonable commercial terms, and adequate remuneration must be paid to the right holder (WTO website). Moreover, the authorisation granted under compulsory licensing must also meet certain requirements. In particular, it cannot be exclusive, and it must as a general rule is granted predominantly to supply the domestic market.

Least developed countries like Nepal are still at worry about the implications of TRIPS on public health in their countries. The implementation period for Least Developed Countries (LDCs) in case of pharmaceutical patents has been extended until 2016. It permits them to delay protecting pharmaceutical patents until 2016. So long as a medicine is not patented in a least developed country, the government does not need to issue a compulsory license to import. But the supplying country would have to issue a compulsory license to export a generic copy of a medicine that is patented in that country as the capacity of LDCs in doing so still weak. Among LDCs Rwanda exercised this system which was used for the first time in September 2008 to ship generic medicines from Canada to treat HIV/AIDS patients.

Would this extension is an adequate for LDCs to address with the possible public health emergencies? The answer is no. Taking few reasons, for example, the case of HIV/ AIDS, Malaria and other mass killing diseases are most common in LDCs. Can we imagine how the poor countries would deal with an H1N1 flu outbreak? Definitely it will be harder for them. Moreover, the economic situation of these countries is so vulnerable, so there is high possibility of deteriorating public health of bottom billions without having access to essential drugs. On the other hand, the degree of technology transfer from the developed countries to the LDCs as stipulated in Article 66.2 of the TRIPS agreement has been rather unsatisfactory, as there have been few instances of technology transfer over the years. Due to poor technological base, LDCs are not in a position to comply with the TRIPS agreement with regard to pharmaceutical patent. Moreover, the technical assistance and capacity building programmes to help LDCs are insufficient.

Present pandemic fear of swine flu highlights the importance of access to essential medicine to safeguard the public health of people. As the virus keeps spreading around the world, with new cases confirmed in Europe and Asia, the risk is becoming higher. Some governments banning flights and preparing quarantines for travelers’ traveled from the affected countries to control the possible threat. Oseltamivir, the currently available medicine for treatment which was developed by US-based Gilead Sciences and is currently marketed by Roche under the trade name Tamiflu is not available adequately in the LDC countries. Here again, the issuing of compulsory license might be an effective way out to supply the essential drug in poor countries. It has increased the importance of Doha Declaration on Public Health.

There were winners and losers in TRIPS Agreement, the developing countries were losers but the condition of LDCs, in this case, was the worst. However, they had no choice at that time. Some developing countries saw IPRs as a mechanism for encouraging foreign investors to bring the latest technologies to their markets which might be possible in other areas of intellectual property. However, the case of pharmaceutical patent is substantially different from other forms of intellectual property. There has been little FDI flow in pharmaceutical sector even though it is directly related with the public health of billion poor people.

In conclusion, the least developing countries need significant development in pharmaceutical technology to comply with the pharmaceutical patent. Until that stage of development, they need complete waiver from the obligation from TRIPS provision on pharmaceutical patent rather than extension of implementation period. To ensure better health care of their people, they have to join their hands with the NGOs, and civil societies working in the public health issue. Moreover, they need to draw more attention of WHO to ensure supply of essential drugs in the LDCs. For these countries, strengthening the provision of public health in the upcoming TRIPS negotiation must be a minimum stand.

(Lila Dhar Adhikari, a section officer Ministry of Industry, Nepal, is currently a student at Seoul National University, Korea. Email: lilaadhikari@yahoo.com)

(Editor’s Note: Nepalis, wherever they live, as well as friends of Nepal around the globe are requested to contribute their views/opinions/recollections etc. on issues concerning present day Nepal to the Guest Column of Nepalnews. Length of the article should not be more than 1,000 words and may be edited for the purpose of clarity and space. Relevant photos as well as photo of the author may also be sent along with the article. Please send your write-ups to editors@mos.com.np)

Have your say ! (Registration required)