TRIPS, Medicine, and the Developing World

TRIPS is a huge agreement in itself, with patents related to the public health sector being only part of it. The part of the agreement that deals with patents, especially regarding the pharmaceutical industry, is what has sent ripples of concern through the public health community. The WTO Web site has devoted a whole section to clarify the relationship between TRIPS and pharmaceutical patents.

TRIPS and Intellectual Property

Patents are defined by the WTO as providing “the patent owner with the legal means to prevent others from making, using, or selling the new invention for a limited period of time, subject to a number of exceptions.”

Although the intention of this agreement is seemingly noble, developing countries have been fretting over the logistics and conditions of flexibility regarding the patenting of medication. Before the ratification of this agreement, rather than depending solely on expensive imported medications, developing countries were also producing drugs locally that were previously discovered elsewhere in the world.

Although it is the right of the inventor to have his or her product or process protected, TRIPS has set approximately 20 years for the expiration of the patent, which has evolved from its protective aim to that of a crippling condition. The WTO’s section on “Philosophy: TRIPS attempts to strike a balance” claims that this will help promote innovation. Yet many developing countries do not have research and development institutes sufficient to compete on a global level, especially with countries that have surpassed them by many years.

The inability of countries to locally produce cheap drugs inevitably places a burden on the people who cannot afford to pay the price of imported medications. This could cause concern in continents such as Africa where fatal diseases like AIDS, malaria, and tuberculosis are rampant.

Mercy for the Poor

The World Health Organization (WHO) estimates that about one third of the world’s population lacks access to essential drugs, and that over 50 percent of people in poor countries in Africa and Asia do not have access to even the most basic essential drugs. Access to essential medicines depends on four critical elements: rational selection and use, sustainable financing, reliable supply systems, and affordable prices.

Civil society groups and non-governmental organizations have criticized TRIPS on the grounds that it imposes various costs on developing countries, such as expensive imported drugs and technologies. For, according to TRIPS, not only is the medication itself subject to patenting, but the processes and the technology used to implement the processes are patented as well. Just buying the know-how to do the work places a burden on some countries.

On June 20, 2001, the WTO’s TRIPS council held a special one-day conference in Doha, Qatar, in response to public concerns worldwide on how patents were causing monopoly situations, such as the exorbitant prices of HIV/AIDS medicine. The meeting was attended by 47 developing countries that unanimously called for confirmation of the flexible interpretation of TRIPS, especially in relation to the use of compulsory licenses⁽¹⁾ and parallel imports⁽²⁾.The TRIPS council was requested to take steps to ensure that TRIPS does not, in any way, undermine the legitimate right of WTO members to formulate their own public health policies and implement them by adopting measures to protect public health. This concern was clarified by adopting the Doha Declaration on TRIPS and Public Health. The Doha Declaration affirmed the sovereign right of countries to take measures to protect public health and to give priority to public health over intellectual property. According to a response from Oxfam International, the details below outline briefly the world health crisis in developing countries:

• There are 40 million people living with HIV/AIDS, including more than 2 million children. Around 3 million people die from AIDS each year, more than a third of them in southern Africa.
• Forty percent of the world’s population is at risk of malaria. More than 300 million people get malaria each year, and at least 1 million die from it. Malaria kills one African child every 30 seconds.
• Around 1.75 million people died from tuberculosis (TB) in 2003. One person is newly infected with TB every second. TB is a very effective killer when combined with HIV/AIDS.
• Today, more than 2 billion people in developing countries lack regular access to the drugs they need, partly because prices are too high.

According to Oxfam, prices on drugs matter because most people in poor countries buy medicines out of their own pocket. Many companies charge whatever they think each market will bear. Their strategy in poor countries often depends on selling low volumes of drugs to wealthier patients, but at prices similar to those in rich countries. Companies can often set extremely high prices because, under WTO rules, every country must grant 20-year patents on new medicines. This stops competition from generic manufacturers who could otherwise produce cheaper versions of the same drug.

In 2000, five international pharmaceutical companies announced price reductions on anti-retroviral drugs for treating HIV/AIDS in Africa. Prices were reduced from US$10,000 per patient yearly to under US$1,000. This was partly achieved as a result of pressure from campaigners. It was also, however, the result of embarrassment over offers from Indian generic manufacturers to supply the same drugs for about US$360. The announcement led to a price reduction race among the multinational companies. Currently, the price of generic Indian anti-retrovirals is under US$200. In 2004, the number of Africans on treatment doubled. However, as the numbers expand, the virus will develop resistance and the need for second-line treatments will grow.

Pfizer meanwhile rejects the notion of cheaper prices for poor countries, claiming that it’s better to donate drugs. While donations may be useful, especially in eradication programs, they are a drop in the ocean and serve public relations more than public health.

Companies are not charities. They must be socially responsible both in their practice, such as in pricing policies, and in the rules and regulations they seek from governments, states Oxfam International.

There is the fear that access to medicine will be for the well-to-do only. As prices of drugs are likely to skyrocket, companies will fear legal action either locally or by the WTO for using protected and patented pharmaceutical processes.

Sources:

• Avert.org
• World Trade Organization
• International Council of Nurses
• Third World Network
• Health Care and Intellectual Property

Charles Mkoka is an independent Malawian environmental writer with much experience in environmental issues. He has worked in the field of environment and natural resources since 1996, after graduating from the Malawi Natural Resources College. Apart from being a writer, he is also a wildlife educator, specialist and guide. You can reach him at mkokach@yahoo.com.

(1) Compulsory licensing is when a government allows someone else to produce the patented product or process without the consent of the patent owner. But the term “compulsory licensing” does not appear in the TRIPS Agreement. Instead, the phrase “other use without authorization of the right holder” appears in the title of Article 31. Compulsory licensing is only part of this since “other use” includes use by governments for their own purposes. Compulsory licensing and government use of a patent without the authorization of its owner can only be done under a number of conditions aimed at protecting the legitimate interests of the patent holder.

(2) Parallel imports are products marketed by the patent owner (or trademark- or copyright-owner, etc.) or with the patent owner's permission in one country and imported into another country without the approval of the patent owner.