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WTO對公共健康的影響

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WTO中有一系例的知識產權條例: Trade-Related Aspects of Intellectual Property Rights (TRIPS) , 要求發展中國家保護大型藥商的知識產權. 很多發展中國家的藥品會分成進口和國內兩種, 譬如說, 同一效力的感冒藥, 進口的比國內的要貴十倍.

可是, 若發展中國家要落實藥品的知識產權法, 內地生產商就要向外國藥商買配方專利才能生產內地版的藥. 因為外國藥商往往財鴻勢大, 當它們進入第三世界國家後, 就會很快起動它的R&D機器, 把本地藥品的配方專利化, 所以國內比較大的藥商會早一步仿效這做法, 這種做法已經把藥物價格推高.

舉一個大家比較熟悉的例子--"雲南白藥", 它本來是一種民間治傷的配方, 以前價錢很便宜, 專利化後升價十倍, 最需要它的民工農民都買不起; 國內藥商的近年積極專利化的舉動, 就是為了準備外國商藥進入大陸.

有人說, 保護藥商的R&D是天公地道的, 但是世界上大部份藥商的R&D資金都是來自政府, 尤其是中國大陸, 大部份的藥品配方都是以前國營企業發展出來的, 私營化後把配方都變成自己的資產.

其實對這方面的條例自己也了解不深, 這裡有一篇比較詳細的文章討論如何在WTO的既有框架下, 減輕藥物利專對公共健康的衝擊.

Crucial public health decision at the Indian Parliament

by Sanjay Basu

A major timepoint has arrived in the implementation of the World Trade Organization's (WTO) policy on the patenting of pharmaceuticals; this year, countries defined as "developing" (middle-income, as opposed to "developed" or "least-developed" nations) will be required by the WTO to implement national laws that enforce stringent 20 year patent protections on pharmaceuticals, as defined in the WTO's Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement.

The patent protections are based on economic theory that has assumed that providing monopolies for selling a good will spark return on research investments, thereby reimbursing inventors. But the pharmaceutical industry rarely requires two decades to recoup costs on its research and development (R&D) for new medications. In fact, 85% of the basic and applied research for the top five selling drugs on the market were produced through taxpayer funding. According to the patent-based drug industry's own tax records (obtained from the Securities and Exchange Commission), Merck last year spent 13% of its revenue on marketing and only 5% on R&D, Pfizer spent 35% on marketing and only 15% on R&D, and the industry overall spent 27% on marketing and 11% on R&D. Meanwhile, all of sub-Saharan Africa constitutes only 1.3% of the pharmaceutical market, so as one former pharmaceutical executive put it, donating drugs to the entire market would result in a profit loss to the patent-based industry equivalent to "about three days fluctuation in exchange rates" (http://www.zmag.org/content/showarticle.cfm?SectionID=13&ItemID=5181).

Given these facts, the manufacturing and distribution of generic pharmaceuticals should be considered a legitimate exercise, and has dramatically assisted in inserting competition into a monopolistic markets--thereby lowering the price of public health goods for poorer patients. Of course, patents are not the exclusive reason for why persons fail to receive proper healthcare in poor countries; but to indicate that healthcare system infrastructure and adequate insurance coverage are also blockages in the pipeline from research to better health outcomes is not to say that patents are not also an important blockage. Indeed, the patents on key malarial medicines are providing obstacles to the dissemination of the best anti-malarials in the tsunami-struck region of Asia, causing physicians there to use second-line, inferior drug regimens.

India has, at least since the late 1970s, provided a key base for the production of generic alternatives to higher-priced drugs from the U.S. and Europe. Numerous countries depend on Indian generic manufacturers; not only for crucial antiretroviral AIDS medications, but also for both basic and molecularly-advanced public health goods. Unfortunately, due to the WTO TRIPS Agreement requirements, India must now pass stringent patent protections for pharmaceuticals, and this could cut off the future supply of generic medicines to poor countries, particularly those who lack their own manufacturing capacity. In addition, India and other "developing" (middle-income) countries were required to institute a "mailbox" in the period between 1995 and 2005, during which pharmaceutical companies could register their products for patent protection once the 2005 WTO deadline was reached and the "mailbox" was opened for patenting approvals. Generic companies in India will have to stop their production of these "mailboxed" drugs if India does not pass flexible patent laws during its current parliamentary session.

Fortunately, the WTO TRIPS guidelines do provide a number of public health protections, and the Indian parliament must make use of these as it continues its current session on the President's Patent (Amendment) Ordinance of December 2004 (the proposed TRIPS implementation strategy). Indian policymakers must enforce a number of protections, some of which the President's policy proposal excludes. In particular, policymakers must make use of the WTO's Doha Declaration on TRIPS and Public Health, which allows countries like India to use "compulsory licenses" for exportation of drugs to poorer countries without manufacturing capacity. These licenses grant generic manufacturers authority to produce drugs without the principal patentholder's permission, under the premise of public health need.

To prevent illegitimate patenting (patenting applications that have been put forth to slow entry of generic pharmaceuticals onto the market), the parliament must adopt a policy of allowing opposition to a patent claim prior to its approval (a "pre-grant opposition"). Similarly, pharmaceutical test data must be kept public, rather than being listed as private company data. Patent-based companies have often claimed that their clinical trial data is proprietary; in reality, this is a measure to slow the entry of generic drugs onto the market. If a patent-based company shows that compound A is effective against disease A, then a generic company need only show that their compound B is the exact same molecule as compound A. There is no need to re-test compound B in a series of clinical trials; indeed, such an act would waste resources and needlessly endanger clinical trial subjects. Finally, the Indian parliament must prohibit the use of patent "evergreening" policies, in which a company claims a "new use" for a drug near the date of the drug's patent expiration, in order to get a new patent on the same compound.

These measure will assist in ensuring that Indian generic manufacturing capacity can continue to supply many poor nations with crucial stocks of much-needed medicines. At the least, the Indian parliament will prevent compounding existing public health problems with new obstacles to proper medication delivery.

For further information, see http://www.msf.org

來自Znet

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