Issues and Definitions
The first step is to learn more about access to medicines. The primers below will provide you with a concise background on each topic and resources to learn more. See Actions for AMSA's official position on these issues.
- Intellectual Property, Patents, and Trade Agreements
- Pricing, Research & Development, and Innovation
- Drug Development, Neglected Diseases, and the Role of Universities
If you want a brief overview of the issues, visit:
- World Health Organization (WHO) list of 10 facts on essential medicines [link to: http://www.who.int/features/factfiles/essential_medicines/en/index.html#]
- WHO Policy Brief on Equitable Access to Essential Medicines [link to: http://whqlibdoc.who.int/hq/2004/WHO_EDM_2004.4.pdf] - pdf [link to: pdf itself]
For definitions of terms used in this website and other literature on access to medicines, see below (adapted from Student Global AIDS Campaign, Glossary of Technical Terms):
- BIOEQUIVALENT: Drugs containing the same active ingredient (e.g. the generic version and the originator's), in the same amount and pharmaceutical form, which have proved to be absorbed and/or excreted in the same way, and can therefore be expected to have the same effects on the human body.
- COMPULSORY LICENSING: provisions in patent laws that allow public authorities to grant licenses to a third party without the consent of the patent holder. Patent-holders receive adequate compensation. Compulsory licenses may be issued on various grounds of general interest, including public health, and are a common feature of patent law. For example, France authorizes them when patented drugs "are only made available to the public in insufficient quantities or quality or at abnormally high prices." Compulsory licenses are neither a form of pirating, a legal loophole, nor a way of stealing intellectual property. Rather, they are part of any good intellectual property legislation, and ensure that a government can counter the negative effects of patents to protect the public interest. For more, see Knowledge Ecology International's FAQ.
- DIFFERENTIAL PRICING: The practice of charging different prices in different markets. See equity pricing.
- DATA EXCLUSIVITY: Trade terms increasingly being pushed by drug companies and the US government that would prevent governments and other companies from using the data from clinical trials and other research submitted by a drug company in the registration process. Generic drugs usually only have to prove that they are chemically identical (or in some cases bioequivalent) to existing approved drugs in order to gain registration, but under extended data exclusivity rights they would have to needlessly repeat trial
- EQUITY PRICING: Pricing policies that ensure that, from the point of view of the community and the individual, the price of a drug is fair, equitable and affordable, even for a poor population and/or the health system that serves them. Equity pricing is based on the principle that the poor should pay less for, and have access to, products such as essential medicines. The terms "differential", "tiered", "preferential", and "discounted" pricing, and "market segmentation" are also often used to describe the practice of charging lower prices in different markets. However, they do not necessarily result in affordability or equitable access to a product. Rather, they are commercial terms for pricing practices aimed at maximizing the profits of the seller. While these practices may lead to equitable access to medicines, they do not necessarily mean that even the lowest prices charged will be affordable. More: MSF on Price Discounts [link to: http://www.msfaccess.org/main/access-patents/introduction-to-access-and-patents/patents-and-access/company-discounts/]
- ESSENTIAL MEDICINES: Pharmaceutical products, both drugs and vaccines, that are defined by the WHO [link to: http://www.who.int/topics/essential_medicines/en/] as "those that satisfy the priority health care needs of the population"
- FREE TRADE AGREEMENT (FTA): An agreement made between two countries (bilateral) or between several countries (multilateral) that sets the terms by which the goods and services produced by one country may be sold in another. Increasingly, these agreements are coming to cover vast new topics that are well outside the area of simply exchanging goods-including everything from ownership of water resources to the ability to produce generic medicines.
- GENERIC DRUG: A pharmaceutical product usually intended to be interchangeable with the innovator product, which is not protected by a patent in the country or is licensed. Generic drugs are marketed either under a non-proprietary or approved name rather than a proprietary name.
- INTELLECTUAL PROPERTY (IP): This term covers a number of different legal rights that are awarded by states to persons in return for some valuable "creative" activity. Two well known examples of intellectual property are patents, which may be awarded to protect inventions, and copyright. A patent allows its owner to stop anybody else from making use of their invention, unless given permission (in return for a payment for example). Intellectual property rights only last for a limited period of time, for example, 20 years for patents, 70 years for copyright. See patent protection.
- INTERNATIONAL MONETARY FUND (IMF): a multi-lateral financial institution created at the Bretton Woods Conference in 1944 that lends money to countries facing a balance of payments shortage (i.e. who are out of money to pay their workers, etc). On all loans it imposes strict financial conditions. (See conditionalities). In addition, the IMF acts as a global credit agency. All World Bank loans are conditioned on declaration from the IMF that the country is financially sound.
- PARALLEL IMPORTATION: importation of patented products without the approval of the patent-holder. Parallel importation allows a country to shop around for the best price of a branded drug on the global market. It is an attractive option for developing countries when the same branded medicine is being sold for different prices in different markets. Parallel importing does not involve the purchase of generics. It would allow a country like Mozambique, where 100 units of Bayer's ciprofloxacin (500mg) costs $740, to import the same product from India where Bayer sells it for $15 (lower price is due to generic competition in India).31 Many European countries, such as the United Kingdom, allow parallel trade to reduce the overall cost of medicines.
- PATENT (PATENT PROTECTION): A form of intellectual property protection granted by a state to an inventor for a fixed period of time in exchange for disclosure of an invention. A patent provides the right to exclude others from making, using, selling, offering for sale, or importing the patented invention (read more at http://en.wikipedia.org/wiki/Patent). Patent protection lasts at least 20 years from the date the patent application was filed. The TRIPS agreement (see below) requires patent protection to be available for inventions in all fields of technology in all WTO Member States. This provision is essentially aimed at pharmaceutical products, for which certain developing countries, as well as developed countries, had refused to grant patents. Patent protection has been an incentive for research and development of new drugs, but questions remain as to whether the patent system will ensure investment in medicines needed by the poor.
- REGULATORY APPROVAL (REGULATORY AUTHORISATION): government authorization of the production and marketing of a drug following proof of its safety and efficacy. This is a process distinct from patenting and takes place on a national level.
- STRUCTURAL ADJUSTMENT PROGRAMS (SAPS): loans granted by the IMF. The loans come with conditions that the recipient country must follow in order for the loan to be approved.
- TRIPS: WTO's Agreement on Trade Related Aspects of Intellectual Property Rights. For more information, please visit the TRIPS material on the WTO website: http://www.wto.org/english/tratop_e/trips_e/trips_e.htm
- TRIPS SAFEGUARDS: Precautionary measures included in the TRIPS agreement to ensure affordability and availability of patented technologies in cases of patent abuse or emergency situation. These safeguards include compulsory licensing, exceptions to exclusive rights and other measures which promote generic competition, and extension of the transitional period. Parallel importation of a patented drug from countries where it is sold more cheaply can also be authorized by governments.
- WORLD TRADE ORGANIZATION (WTO): an international organization that sets rules for the global trading system.