The terms of this glossary are divided as following:
1. International agreements, declarations and laws.
2. Technical terms
3. Official institutions and organizations
4. Non-governmental institutions and organizations
The elaboration of the glossary was based on the following documents:
• “Intellectual Property, Patents & Universal Access to Medicines” by Alexandre Grangeiro, Andrea Lazzarini Salazar, Fernando Fulanetti, Jorge Beloqui, Karina Bozola Grou and Mário Shaffer. Responsible institutions: Incentivo à Vida (“Life Incentive”) Group, Pela Vidda (“For ‘Life’”) Group from São Paulo, São Paulo’s Reference and Training Center in STDs/AIDS, and the Health Institute of São Paulo.
• “Why is access to medicines made difficult?” by Gabriela Costa Chaves, organized by Renata Reis, Veriano Terto Jr., Cristina Pimenta and Richard Parker. Institution responsible: Brazilian Interdisciplinary AIDS Association (ABIA, acronym in Portuguese).
• AIDS Agency’s Dictionary. Access on January 30th, 2007. Available at: <http://www.agenciaaids.com.br/dicionario2.asp> (content in Portuguese).
• Brazilian Legislation on intellectual property
• TRIPS Agreement
1. International agreements, declarations and laws
• TRIPS Agreement
The Trade-related Aspects of Intellectual Property Rights Agreement is an international agreement which settles the rules of the intellectual property system: what may be protected, which are the rights granted to its holder, what is the patent term, what to do when there are conflicts among countries which signed the Agreement, among other aspects. It was created in 1994, in the Uruguay Round, with the WTO — World Trade Organization. All the Member States of the WTO are obliged to sign the TRIPS Agreement.
• Federal Constitution
The Constitution is the fundamental law of a country. In it are the legal norms which rule the State, its government, the use of power, the limitations of established organs in their use of power, the rights and guarantees of the people. The Federal Constitution currently in force in Brazil was established in 1988. The right to life, health, and the right to property are foreseen in the Brazilian Constitution, which also contains the solution to cases regarding conflict of interests. For example, this conflict may be a result of tension between the right to patent protection (a result of the right to property) and the right to access to medicines, which considers the right to health. Property and free exploration of economic activities may and should suffer restrictions to answer to social functions, such as guaranteeing proper living conditions and people’s health.
• Doha Declaration
The Doha Declaration on the TRIPS Agreement and Public Health affirms that public health is the priority in relation to trade interests and patents. It was signed in 2001 during the Fourth WTO Ministerial Conference in Qatar, in the city of Doha. The Declaration was important to reinforce the safeguard provisions foreseen in TRIPS, emphasizing each country’s right to decide which situations would be correctly d as ‘national emergencies’ or ‘circumstances of extreme urgency’, highlighting the legal use of compulsory licenses.
• Universal Declaration of Human Rights
The Universal Declaration of Human Rights, made known in 1948 by the United Nations (UN), is an international benchmark in human rights. It is the base of two important treaties: the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights, both approved by UN’s General Assembly in 1996. Both treaties are recognized in Brazil since 1992, when ratified by the Congress and the President.
The General Agreement on Tariffs and Trade (GATT) was established at the end of the Second World War and, together with the International Monetary Fund (IMF) and the World Bank, formed a regulatory system for world economy until the creation of the WTO. International negotiation rounds marked GATT’s functioning and the last one, the Uruguay Round, was the birthplace of the institution which would later substitute it — the World Trade Organization (WTO).
• Brazilian Patent Law (n.9274/96)
Law n.9279, in force as of May 14th, 1996, is the Brazilian law which establishes the rights and duties related to industrial property: invention, utility model — protected by patents, and industrial design and brand, whose protection depends on a different procedure. It was elaborated based on the TRIPS Agreement and approved nearly ten years before the end of the transition period granted to developing countries for their adaptation to the Agreement’s rules.
• August 30th, 2003, Resolution
The resolution controls a Doha Declaration mechanism and represents an amendment to the TRIPS Agreement. It allows countries which do not have the capacity to produce medicines to use the compulsory license to import generic versions of medicines. However, there are several rules to be followed when using the license: the importing country must demonstrate lack of capacity and formalize its need for the medicine, informing the quantity needed; and the exporting country must also grant compulsory licenses and send only the amount to fulfill the necessities of the demanding country.
• Free Trade Agreements (FTAs)
These are bilateral or regional agreements with the objective of decreasing of bringing to an end any commercial barriers between signing countries. Many times, these agreements may be prejudicial to poorer countries when including, for example, TRIPS-Plus provisions.
• TRIPS-Plus provisions
This is how the mechanisms, present in national legislations or in free trade agreements, which intensify TRIPS’ restrictive character, since it strengthens the patent holders’ rights when, for example, extending the patent term or preventing or hampering the use of the TRIPS flexibilities.
2. Technical terms
• Neglected diseases
Neglected diseases are categorized as such for not attracting big pharmaceutical companies in regards to research and development of medicines. Without the proper medicines to treat effectively, they are responsible for millions of cases involving illness and death worldwide, especially affecting poorer populations. These are some of the called neglected diseases: chloroquine-resistant malaria, visceral leishmaniasis (Calazar), lymphatic filarisis, human African trypanosomiasis, Chagas disease, schistosomiasis and tuberculosis.
• Bolar Exception
The instrument called Bolar Exception is a permission for others, not the patent holder, to explore the patented product to perform necessary tests in order to be obtain the the market authorization by the Drug Regulatory Authority. With this mechanism, you no longer have to wait until the end of the patent term to initiate research and registration processes of a generic version of a medicine. In Brazil, the Bolar Exception is foreseen by Law n.9279/96.
• Active Pharmaceutical Ingredient (API)
Part of the medicine which guarantees its therapeutic effect.
• Parallel importation
Parallel importation is a mechanism which allows the importation of a patented medicine at a more affordable price than found in the country. Instead of procuring it from a local representative of the patent holder, the deal is made with the company or an authorized part in another country where the same product is sold at a lower price.
• Compulsory license
The compulsory license, commonly called as “patent breaking”, temporarily withdraws the patent holder’s monopoly. It may only be determined by State and allows that private or public laboratories, with production capacity, to manufacture the patented product for an established period of time. National legislations must foresee the specific requirements in issuing a compulsory license.
The Brazilian Patent Law authorizes the issuing of a compulsory license in several situations, stressing licenses referent to abuse of rights, abuse of economic power, and in possibilities of national or public interest.
The patent holder may be obliged to collaborate in the technology transference for the manufacture of the product, therefore teaching all steps required for its production — regardless of previous publication of all information regarding the production of the medicine when the patent application was filed. Even during the compulsory license period, the patent holder’ rewards are guaranteed.
• Generic medicine
The generic version of a medicine is equivalent to the patented medicine (reference product), but is produced by others which are not the patent holders. It contains the same active ingredient — in the same dosage and pharmaceutical formula — and is administered in the same way with identical indications of use. And, most importantly: it is as safe and effective as the reference medicine, and generally is available at more affordable prices.
Patents are titles granted by State which guarantee their holders the exclusive exploration of their creations (inventions and utility model) during a specific period of time, which may not be less than 20 years, according to the TRIPS Agreement.
• Second use patents
Second use patents are those granted for products which, initially created for a specific illness, are later discovered as useful for other sicknesses. For example, a medicine developed and used for the treatment of cancer later begins to be used effectively for HV/AIDS. The TRIPS Agreement does not oblige granting patents for second use, as is also established by the Brazilian legislation.
• Pipeline patents
Many national legislations did not allow patents for some technological fields, such as medicines or food products. With the TRIPS Agreement, granting patents for all fields became an obligation. Brazil incorporated pipeline patents with Law n.9279/96. Also called revalidation patents, pipeline patents allowed that patents granted in other countries were validated in Brazil without the analysis of the patentability requirements, for as long as the patent term in the country of origin. In Brazil, many medicines were patented through this mechanism.
Acronym for Research and Development.
• Intellectual Property
Intellectual property rights are exclusivity rights granted to companies or people for their creations, obtained through their intellectual activity and talent. The creations consider industrial property and literary and artistic property (copyrights).
• Industrial Property
The industrial property rights are those related to industrial or commercial activities which regard inventions, brands, industrial design, utility model, geographical indications, topographic integrated circuits, and vegetable sources.
• Bioequivalence testing
This test is performed with generic versions of medicines to attest its identical therapeutic effect on the human organism when compared to the medicine of reference.
• Experimental use
It is an authorization granted for a patented product to be used in scientific research and investigation. It is a way to promote the technological development of a country, one of the principles foreseen by TRIPS, since it allows the use of information and knowledge regarding the medicine, made available by the patent holder when filing a request.
3. Organisms and official institutions
• ANVISA — National Health Surveillance Agency
The National Health Surveillance Agency was created by Law n.9782, issued on January 26th, 1999. It is an autarchy under a special regimen, in other words, a regulatory agency characterized by its administrative independency. A Collegiate Directory of five members is responsible for ANVISA’s management. The Agency’s institutional objective is to promote the protection of the population’s health through sanitary control of the production and trade of products and services which are subject to sanitary vigilance, including related environments, processes, products and technologies. The Agency also controls docks, airports and national borders, and the dialogue with the Foreign Affairs Ministry and foreign institutions in regards to international topics related to sanitary vigilance. In regards to medicines, the organ holds the responsibility of authorizing and registering all medicines in the country. Plus, since 2001, it is also responsible for the prior consent for medicine patent applications, which proves to be a way to halter patent granting for medicines which do not fulfill the proper requirements.
The Technology Institute in Pharmaceutical Products, Farmanguinhos, is a public laboratory under Fiocruz. It is a national reference center in research, technology and medicine production.
• Food and Drug Administration (FDA)
North American agency, under the Health and Human Services Department, responsible for the regulation of food products, cosmetics, medicines and medical devices, among others. It corresponds to ANVISA’s role in Brazil, respecting their particularities and differences.
The Oswaldo Cruz Foundation is a public institute under the Ministry of Health which, besides researching in scientific fields, develops medicines and vaccines, offers specialized training, implements social programs, among other activities.
• National Institute of Industrial Property (INPI)
The National Institute of Industrial Property is the organ, under the Development, Industry and Foreign Trade Ministry, which controls the country’s norms on industrial property, held responsible for technology transfer contracts and for brand and patent granting.
To grant and file for patents, INPI has to make sure that the application is really an invention — if it fulfills the requirements regarding novelty, inventive active and industrial application. INPI is held responsible for rejecting any artifices used by pharmaceutical companies to further extend their monopoly.
• World Trade Organization (WTO)
The World Trade Organization was established in 1995, as a result of the Uruguay Round which had come to an end in 1994, and is the successor of GATT. Its function is to monitor the commercial agreements established by their member States. Its establishment occurs in a context of a single worldwide market, with rules for the homogenization of national laws regarding international trade and the management of trade-related disputes between countries. Currently, there are 148 countries which take part in the organ, including Brazil. Many call the organization a “GATT with claws” since, not in the same manner as other international organs, it may punish the countries which violate WTO’s settlements.
• World Intellectual Property Organization (WIPO)
The World Intellectual Property Organization is the special UN agency on intellectual property. It has 184 member States and was established in 1967. It holds the responsibility to administer the Paris Convention and other international treaties, with the exception of the TRIPS Agreement, which is managed within the WTO.
• World Health Organization (WHO)
The World health Organization is the special UN agency on health issues. It was established in 1948 and currently holds 193 member States. Its supreme decision-making body is the World Health Assembly (WHA).
• Pan-American Health Organization (PAHO)
The Pan-American Health Organization is a regional representative of the WHO in the Americas.
• United Nations Development Program (UNDP)
The United Nations Development Program is a UN organism which has as its purpose promoting development and eliminating poverty. UNDP elaborates the Human Development Index (HDI) and coordinates the activities of other agencies, funds and UN programs.
It also propagates the Millennium Development Goals: a set of eight objectives, 18 goals and 48 indicators of worldwide development to be reached by the year of 2015. Among them is the objective of fighting HIV/AIDS, malaria and other diseases.
• National STDs and AIDS Program
The organ under the Ministry of Health with the responsibility of coordinating the national policy in fighting AIDS in the stages of prevention, diagnosis, treatment and in reducing the stigma and prejudice, aiming to reduce the HIV/AIDS incidence and improving the life quality of people living with HIV/AIDS. Through pacts with federal, state and municipal governments, the organ is responsible for the purchase and distribution of antiretrovirals to the public health system.
• Unified Health System (SUS, acronym in Portuguese)
The Unified Health System, instituted by the 1988 Federal Constitution, guarantees all Brazilians access to services necessary for the prevention and recovery of health, which includes access to medicines. There is no need to pay for them directly, since the health services are to be financed by the taxes paid by the population. According to legislation, all people have the right to receive from SUS the medicines they need.
UN’s special program, uniting 10 of its agencies, responsible for the coordination of an integrated approach to fight AIDS in at global level.
United Nations Educational, Scientific and Cultural Organization
United Nations Children’s Fund
• United States Patent and Trademark Office (USPTO)
American agency under the Trade Department, responsible for issuing patents.
4. Organisms and non-governmental institutions
• Brazilian Interdisciplinary AIDS Association (ABIA, acronym in Portuguese)
The Brazilian Interdisciplinary AIDS Association was founded in 1986 as a solidarity network in the fight against AIDS, integrated by professionals of several political sectors and social movements, among them was the sociologist Herbert de Souza.
Brazilian Pharmaceutical Chemistry Industries Association unites several companies from the national pharmaceutical sector.
Brazilian Intellectual Property Association unites companies, advocacy offices and specialists in order to formulate researches on intellectual property, besides promoting seminars and events on the issue.
• AIDS News Agency
Is the Brazilian news agency specializing in covering AIDS-related issues in the country and worldwide.
• Consumer Project on Technology (CPTech)
With its headquarters in Washington, the organization works mainly with topics related to policies regarding production and access to knowledge, such as medical inventions and cultural pieces. It has an extensive collection on policies regarding medicine patents.
• Drugs for Neglected Diseases Initiative (DNDi)
An initiative taken by several organizations to fight the so-called “neglected diseases” — diseases which millions around the world, but do not have adequate treatment since there are not commercially interesting. Among its members are Fiocruz, Pasteur Institute and the Doctors without Borders (Médecins sans Frontièrs).
The Brazilian Federation of the Pharmaceutical Industry unites unions and associations of the national pharmaceutical industry.
• Global Forum Health
Forum which has as its goal the development of health-related studies, and intervention and international policy-making regarding a more equitable approach to research and development of tools which answer to current neglected matters.
• Brazilian Intellectual Property Institute (IBPI, acronym in Portuguese)
The Brazilian Intellectual Property Institute has as its purpose studying and disseminating the intellectual property topic.
• Doctors without Borders (Médecins sans Frontiérs, or MSF)
MSF is a humanitarian aid organization formed by doctors who assist populations affected by catastrophes, epidemics, conflicts and social exclusion. It has an important access to essential medicines campaign.
Oxfam, short for Oxford Committee for Famine Relief, is a humanitarian aid organization created after World War II. It acts in an international level in several areas, such as health, education, trade, and the environment. It has specific campaigns for fighting AIDS and guaranteeing access to medicines.
• Cultura Livre Project (“Free Culture”)
Project created by the Technology and Society Center in partnership with the Getúlio Vargas Foundation and the Link Centre from South Africa. Its intention is to create a dialog among the southern hemisphere countries about culture, media, and intellectual property.
• Access to Knowledge Project (A2K)
The site has a weblog and intends to disseminate content on the need for international policies for access to knowledge and technology.
• Public Patent Foundation (PUBPAT)
American foundation which has as its goal to represent the public interest when facing the hazards brought by the patent system, especially those related to unmerited patent protection.
• Brazilian Network for the Integration of Peoples (Rebrip, acronym in Portuguese)
The Brazilian Network for the Integration of Peoples, formed by about 40 civil society bodies (NGOs, social movements, unions, etc.), has as one of its main goals articulately confronting the free trade agreements, the bilateral trade agreements and the WTO. Rebrip organized itself through working groups, one of them dedicated to intellectual property with great emphasis in medicines - the Working Group on Intellectual Property (GTPI, acronym in Portuguese).
The Pharmaceutical Industry Union is a union from São Paulo which unites several companies of the regional pharmaceutical sector.