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'TRIPS' stands for Trade-Related aspects of Intellectual Property Rights. It is an Agreement drawn up by the World Trade Organisation between 1986 and 1994 to ensure intellectual property rights are respected within international trade. It came into force on 1st January 1995, although implementation dates vary from country to country. What are Intellectual Property Rights?When someone comes up with a process, product, invention or design that is likely to bring them notoriety or money, there are always going to be those that are tempted to steal or copy their idea. Intellectual property rights are there to ensure this doesn't happen. They can take a number of different forms, but the most commonly known are patents (for inventions and drugs etc.), copyright (for books, films and images) and registered trademarks (for company logos, slogans and brand names). How does TRIPS work?The TRIPS agreement brings intellectual property rights under one common set of international rules and establishes the minimum levels of protection that all governments within the World Trade Organisation must give to the intellectual property of fellow members. The TRIPS agreement can only be enforced by the laws of individual countries however; it is not an automatic universal law. For example, if country A had no intellectual property laws whatsoever, then there would essentially be nothing to stop its citizens copying, say, a new type of toaster produced by country B, even if country B did have laws to protect it. TRIPS ensures this doesn't happen by encouraging countries to introduce its rules as law (or face severe penalties from the World Trade Organisation). Once these laws are set up in country A therefore, country B could then register the patent for the toaster with them, and copying and reproducing it would become illegal. Which countries have to comply with TRIPS?All the members of the World Trade Organisation (147 countries in total) will eventually have to comply with TRIPS. When it was introduced in 1995, developed countries were given 1 year to ensure their laws complied; developing and certain transition economies were given five years (to 2000) and least developed countries were given until 2006 (now extended to 2016 in the case of pharmaceutical patents). What are Generic Drugs?There are basically two forms of drug - proprietary (or 'brand-named') drugs that are developed and produced by large multinational pharmaceutical companies, and generic drugs that are either copies, or the basic form of a proprietary drug. Paracetamol for example is the generic form of Panadol® or Tylenol®. The companies that make these brand-names may spend thousands on marketing and inventing new formulations, but the basic active ingredient in their tablets is just standard paracetamol which can be bought without the label for far less money. Paracetamol can be made generically because there is no longer a patent on it (patents only last 20 years). However, drugs that are in patent can also be copied under certain conditions, and are also known as generics. But how can patented drugs be copied? Doesn't the TRIPS agreement make this illegal?Normally patent protection rules under TRIPS would make it illegal to copy any proprietary drug that was still under a patent. However, following the WTO Doha ministerial conference in 2001, ministers agreed that TRIPS should not prevent members from taking measures to protect the public health of its citizens. It therefore agreed that countries should be able to manufacture generic drugs made before the 1995 introduction of TRIPS and could produce newer drugs under a system called compulsory licensing. What is compulsory licensing?A compulsory license is a government license that enables people other than the patent holder to copy patented or copyrighted products and processes. Governments can issue them if a patent owner abuses their rights by, for example, failing to offer their product on the market, or offering it at price that is too high for potential buyers to afford. Competitors can then produce the product or use the process under government license without fear of prosecution. In the case of generic drugs, compulsory licenses can be issued because of the high (and for developing nations, often unaffordable) prices charged by the major pharmaceutical companies for their products. Which countries produce generic drugs?There a number of countries producing generics including Canada, Brazil, South Africa, China and Singapore. However, the biggest producer of generics is India. Not only do Indian companies make the finished tablet form of drugs, they also produce cheap generic versions of the raw ingredients and chemicals used in their manufacture, many of which are actually exported to major multi-national companies to produce their brand-named versions. Wouldn't it be a good idea for someone to produce generic forms of AIDS drugs then, if they're so much cheaper?A number of countries already do. Brazil has a very large generics industry that enables its government to supply free antiretroviral (ARV) AIDS drugs to everyone that needs them. India too produces large volumes of ARVs, both for its own people and for export. However, TRIPS could be about to make generic production a little more difficult in India. Until the end of 2004, India was a little like country A in the example above: it had no regulations on patenting (which is one of the reasons generics manufacture has become such a large scale industry there). On 1st January 2005 however, the 5-year transition period specially awarded to India to help the country conform to TRIPS came to an end and new patent laws came into force. Does this mean that India can no longer copy ARV drugs cheaply?Thankfully not. Although most of the ARVs that feature on the World Health Organisation's list of 'essential' treatments didn't become physically available on prescription until 1996 or later, the vast majority were actually patented well before TRIPS was introduced in 1995, and can therefore continue to be produced legally. However, for drugs patented between 1995 (when TRIPS was introduced) and 1st January 2005 (when India introduced its TRIPS-based patent laws), it is a different story. Most of the producers of these drugs will have filed for patents in India, which, if granted, would last for 20 years, preventing any generic copying during this time, and forcing all current production to stop. The only way around this problem would be for the Indian government to grant compulsory licenses. Sadly these are not without their problems. They can be difficult and complicated to impose and require a great deal of government time and departmental cooperation to draw up. They also have political implications, as companies and countries that hold the original patents to drugs are unlikely to want to invest in a nation that is copying their products. The ARV drug Combivir (zidovudine/lamivudine combination) is one of the few that are likely to be affected as it was patented after 1995. What about other nations with high levels of HIV? Could they produce their own drugs?In theory, yes, if their government were willing to set up compulsory licenses for any drugs under patent. They would also have to be able to show that the country is suffering a serious health crisis. So far the only developing nation to have done this is Zambia, who declared a state of national emergency in September 2004 to demonstrate the scale of the HIV/AIDS problem within the country. Other countries have been less willing, for political as well as practical reasons. Pharmaceutical industries require expertise and substantial resources to set up, as well as a readily available source of basic raw ingredients. A method of regulating drugs would also need to be implemented (or already exist) within the country. At present the WHO does run a very successful scheme to assess generic drugs on a global scale and ensure they are bioequivalent (i.e. the same) as their proprietary counterparts, but even they stress that they are not a regulatory or drug-safety body and should not be treated as such. So what happens in countries that really can't manufacture their own drugs? Can they import them?The members of the WTO battled with this problem for several years, as exporting and importing generic drugs is quite different from producing them for use within a country itself. A generic drug that may be legally produced in India for example, could be under patent (and therefore illegal) in say, Kenya. The solution that the WTO came up with was to invite members that were unable to produce pharmaceuticals at home and were suffering a serious health crisis, to import generics from other nations under compulsory licenses. This was known as the 'paragraph 6' waiver and was introduced to the TRIPS agreement in 2003. Nevertheless, as with producing countries, compulsory licenses are not without problems and some nations have been reluctant to enforce them for fear of jeopardising the supply of aid and investment (and brand-named AIDS drugs) from wealthy nations. Is there any other way round the TRIPS regulations?Major pharmaceutical companies can decide to bypass the TRIPS system and make it easier for their drugs to be produced generically by issuing voluntary licenses. This basically means that the patent holder allows other people to copy their drugs under certain conditions. In 2001 for example, thirty-nine major pharmaceutical companies tried to prosecute the South African government for passing a law (which they said was against TRIPS regulations) that allowed easy production and importation of generics. Following immense pressure from the South African government, the European Parliament and 300,000 people from over 130 countries that signed a petition against the action however, they were forced to back down. In an effort to put an end to the continuing row, one of the companies, GlaxoSmithKline, even granted a voluntary license to a major South African generics producer (Aspen), allowing them to share the rights to their drugs AZT, 3TC and the combination Combivir without charge. In return, Aspen had to promise to give 30 percent of their net sales to one or more non-governmental organisations fighting HIV and AIDS in South Africa, which they continue to do to this day. Are there any other problems with TRIPS regulations?Unfortunately price increases are one major problem associated with new laws. As competition and the number of newer drugs being produced falls, so generic drugs companies have to increase prices of existing products to survive. Are there any benefits?Yes. It is hoped that by making the simple 'reverse-engineering' of other company's drugs more difficult, generic drugs manufacturers will start to invest more in research and development, and will ultimately come up with original low-cost medicines themselves. Some companies in India (such as Cipla and Ranbaxy) have already been doing this. Taking advantage of the fact that they are able to make lots of different drugs from lots of competing pharmaceutical companies, they have combined various ARVs into one-a-day, easy-to-take fixed-dose combinations that would be very difficult to manufacture in developed nations. Such drugs are vital to treating AIDS in the developing world, as the simpler a treatment, the easier it will be for an HIV+ positive person to take them regularly. TRIPS also encourages technology sharing, which could lead to pharmaceutical companies (both generic and multi-national) sharing expertise, giving more developing countries the capability to produce drugs for their own people. AVERT.org has more about the issues involved in providing treatment and about drug access targets and results, as well as a table of drug access statistics. Author: Bonita de Boer. Sources:
Last updated February 22, 2005 |