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PubMed2000

US files WTO complaints against Brazil over requirement for "local working" of patents.

At the end of May 2000, the US (later joined by the European Communities) filed a complaint against Brazil at the World Trade Organization (WTO), alleging Brazil was in violation of its obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement) and the 1994 General Agreement on Tariffs and Trade. Brazilian legislation that came into force in 1997 establishes that, in order to enjoy exclusive patent rights in Brazil, the holder of a patent on an invention must satisfy a "local working" requirement. In other words, the patent holder must "work" the patent in Brazil to enjoy full patent protection. If it fails to do this, the law says it shall be subject to the possibility of the government issuing a compulsory license, allowing someone else to use the invention and pay a royalty fee to the patent holder.

Anti-HIV Agents↗
PubMed2006

Biodiversity, biopiracy and benefits: what allegations of biopiracy tell us about intellectual property.

This paper examines the concept of biopiracy, which initially emerged to challenge various aspects of the regime for intellectual property rights (IPR) in living organisms, as well as related aspects pertaining to the ownership and apportioning of benefits from 'genetic resources' derived from the world's biodiversity. This paper proposes that we take the allegation of biopiracy seriously due to the impact it has as an intervention which indexes a number of different, yet interrelated, problematizations of biodiversity, biotechnology and IPR. Using the neem tree case as an example, it describes activists' use of the term as one that involves a deliberate simplification of science and IPR. Additionally, it argues that in so doing, biopiracy is positioned as a touchstone that mobilizes actors and problems, and ultimately generates 'solutions' to the very challenges it creates. The paper will also encourage a view of biopiracy claims that does not always treat them simply as claims of theft, or as a misallocation of benefits, but rather as claims that are designed to raise broader questions about the IPR system itself. It concludes by advocating that, in order to properly understand how to address biopiracy, we must be prepared to move beyond the current narrow readings to develop a more complete picture of the term's influence in challenging how, and by whom, the decisions about what is natural and what is invented come to be made.

Animals↗
PubMed2000

Impacts of international trade, services and investment treaties on alcohol regulation.

There is an underlying incompatibility between government efforts to minimize the harm associated with alcohol, particularly by regulating its supply, and international commercial treaties that promote the freer flow of goods, services and investment. These treaties have already forced changes to many government measures affecting alcohol availability and control, primarily by constraining the activities of government alcohol monopolies and by altering taxation regimes. The North American Free Trade Agreement and the World Trade Organization agreements open new avenues for challenges against alcohol control measures. Some of these agreements extend beyond trade, border measures and differential taxation and allow challenges that intrude into areas of non-discriminatory domestic regulation affecting market access, intellectual property, investment and services. Effective protection from these agreements for vital public health measures has rarely been obtained, although it is increasingly essential. The WTO "services" agreement, basically unknown to the public, is currently being re-negotiated and poses the gravest new challenge to policies designed to influence patterns of alcohol use and minimize alcohol-related harm. In future, these international agreements will probably affect adversely those alcohol approaches considered to be the most effective or promising. These include: maintaining effective state monopolies, restricting the number and locations of retail outlets, taxing and regulating beverages according to alcohol strength, restricting commercial advertising, and maintaining and enhancing public alcohol education and treatment programs. These effects can, in turn, be expected to increase the availability and access to alcohol, to lower alcohol taxes, and to increase advertising and promotion, resulting in increased alcohol consumption and associated health problems. Until more balanced international rules are developed, the challenge facing alcohol policy researchers is to defend national and local alcohol measures from further erosion. This will require greater coordination with researchers in other affected sectors, intervention with government representatives in health and related areas and the promotion of alternative approaches to current international commercial agreements.

Alcohol Drinking↗
PubMed1988

Self-organizing system obtaining communication ability. Primitive model for language generation.

As one of the synthetic approaches to brain functions, the possibility is discussed that two intellectual robots could make "words" for themselves and come to communicate with each other. Associatron, a model for associative memory with a neural network structure, is used as the memory in the brain, and information from the outer world is accumulated in it. Concepts regarding objects and attributes are extracted from the stored information, where the Associatron properties are utilized. The robots give specific names to the concepts and interchange them with each other. When the robots have the same experience at the same time, they modify their own words according to what the other robot says. As they repeat common experiences, the differences between the words become smaller and smaller, and finally the robots agree on a word for each object. At this stage, the robots can exchange information with their words and each can act accordingly on the word from the other. This study shows that the self-organizing system with the above function can be constructed as a neural network model.

Artificial Intelligence↗
PubMedDate not supplied

The World Trade Organization: implications for health policy.

Agreements negotiated at the World Trade Organization already have important implications for health and health policy. They impact on the ability of governments to regulate trade in the interests of health; on national and international governance and public health standards; and on the future of the precautionary principle. Agreements on trade-related aspects of intellectual property rights and trade in health services could benefit the multi-national health care and pharmaceutical industries, and impact negatively on cost and equity.

Developing Countries↗
PubMedDate not supplied

Patents and access to essential drugs.

This paper provides a brief overview of historical developments in patent law including its recent incorporation into world trade law. The impact of patents on access to essential drugs will be discussed. The relationship between intellectual property rights and the right to health will be considered.

Commerce↗
PubMed2001

Reprivatizing pharmaceutical supplies in Africa.

Perhaps no part of the health system is as imperiled by neoliberal economic reforms as the public drug sector. The national bill for pharmaceuticals can claim one-third of a developing country's annual health budget. This article describes the essential drugs program created by WHO in the 1980s to protect financially reduced ministries of health from the high prices charged by multinational pharmaceutical companies. It describes the backlash from the World Bank and UNICEF, which launched the Bamako Initiative and other community financing schemes and revolving drug plans in which individuals, families or community groups buy drugs above the wholesale purchase price; clinics use the proceeds to maintain drug supplies and subsidize other health services. When this plan failed, the Bank proposed outright privatization of drug purchase and supply, returning power to the multinational suppliers. The article ends with a consideration of patents and the new intellectual property rights as they pertain to pharmaceutical production in Africa.

Africa↗
PubMed2005

Intellectual property rights and the Canadian pharmaceutical marketplace: where do we go from here?

Patent protection for prescription drugs has a long and contentious history in Canada. Bills C-22 and C-91, passed as part of Canada's commitment to various trade deals, first weakened and then abolished compulsory licensing. In order to decide on a future course of action that Canada should take on intellectual property rights (IPRs), it is useful to review downstream effects that resulted from C-22 and C-91. This article examines changes to employment, Canada's balance of trade in pharmaceuticals, investment in research and development, and drug expenditures. The author then reviews the arguments advanced by the pharmaceutical industry in favor of stronger protection for IPRs, the recent complaints made against Canada at the World Trade Organization regarding pharmaceutical IPRs, and the continuing argument about the "evergreening" of patents. Also discussed are the second-draft text agreement of the Free Trade Area of the Americas, which will, if implemented, have significant repercussions for pharmaceutical IPRs in Canada, and some ways in which patents distort the marketplace for drugs. The article concludes with some alternative recommendations on the future of IPRs.

Biomedical Research↗
PubMed2002

The World Health Organization and the Pharmaceutical Industry. Common areas of interest and differing views.

No article published in the scientific press in the last 10 years reviews the various areas of interest common to the World Health Organization (WHO) and the pharmaceutical industry. Despite a vast amount of information in the public domain, the policies expound the views only of the bodies they represent rather than comparing differing views. An understanding of the factors which affect the interaction between these organisations as well as the organisational structures and the actual areas of intersecting interest, may help to find ways for the industry to assist the WHO in its endeavours in developing countries. Modern drug development is performed initially in and for western society, leaving the areas of infectious or tropical diseases with relatively less industry investment than cancer and cardiovascular disorders. Aspects of the development of an ethical drug, regardless of its therapeutic class (selection of drug name, intellectual property rights, drug safety, marketing and pricing, quality assurance and counterfeiting, generic use, emerging drug donations) are influenced to varying degrees by the triad of money, politics and medical need and the perspectives (each defensible) placed thereon by the WHO and industry. Instead of simply defending their positions combining the best of these strategies to optimise drug development for the needs of developing countries appears logical. Similarly, via its philanthropic initiatives, industry will have donated over $US1 billion in drug and research aid in the period 1995 to 2005. These charitable projects should yield useful information for planning and organising future aid efforts. Global warming, only recently given serious governmental consideration, is an area not yet addressed in drug development policy although along with geographical effects, it is likely to have an impact on the epidemiology of diseases e.g. malaria returning to the Mediterranean, worldwide. With changing disease patterns (and particularly if the western world is affected directly), a shift in emphasis on future medical needs and drug development can be anticipated. Furthermore, given the increased modern interest in herbal medicines and the fact that poorer countries rely heavily on traditional medicines, archiving of botanicals under threat would preserve plants for future medicinal testing or use. Coupled with the environmental and poverty issues that the WHO already attempts to address in developing countries, it is timely for both bodies to work towards certain agreed mutual aims. To work effectively, it is realistic that both bodies must benefit and also make concessions in this interactive process.

Developing Countries↗
PubMed1998

Trade Related Aspects of Intellectual Property Rights (TRIPS) and the threat to patients: a plea for doctors to respond internationally.

Many recent international agreements sponsored by bodies such as the World Trade Organisation (WTO), aim to facilitate the global free flow of goods, services and capital, by opening markets under the threat of trade sanctions. Nation States signing such agreements, in particular the Trade Related Aspects of Intellectual Property Rights (TRIPS), agree to suffer a sovereignty deficit in order to enhance their trading prospects. In the resulting reorganization of trade, medicine may be marginalised as merely another industry that must open its regional doors in the interests of global corporate productivity. We make a plea for medical organizations to lobby in appropriate international forums to create "hard" norms that ensure such international trade agreements that adequately respect the demands of fundamental ethical principles of the doctor patient relationship, principles such as medical loyalty and beneficence.

Ethics, Medical↗
PubMed2002

Genomics, health, and society.

On June 27, 2001, the World Health Organization conducted hearings in Geneva for a Special Report on Genomics & Health. Initially intended as a document to address the ethical, legal, and social implications of the gathering genomics resolution (ELSI), the terms of reference of the report were significantly modified to give primary emphasis to a scientific and technological assessment of the implications of genomics for human health. The Citizens' Health Initiative, one of two NGOs invited to make submissions at these consultations, suggested that no less important than the scientific and technical assessment was a perspective which gave due attention to the social context and political economy of scientific/technological development and its deployment. The article below touches upon neglected health priorities of poor countries, intellectual property rights and patents, risk management, insurance and discrimination, and predictive (prenatal) testing, reproductive choice, and eugenics.

Journal Article↗
PubMed2004

Defining minimum standards of practice for incorporating African traditional medicine into HIV/AIDS prevention, care, and support: a regional initiative in eastern and southern Africa.

In many resource-poor settings of Africa, a majority of people living with HIV/AIDS depend on and choose traditional healers for psychosocial counseling and health care. If the current pan-African prevention and care efforts spurred by the HIV pandemic do not actively engage African Traditional Medicine, they will effectively miss 80%, the vast majority of the African people who, according to the World Health Organization, rely on traditional medicine for their primary health care needs. In 2001, the Ugandan nongovernmental organization, Traditional and Modern Health Practitioners Together Against AIDS and Other Diseases, in Kampala, identified the need for a concerted, systematic, and sustained effort at both local and regional levels to support and validate African Traditional Medicine on several fronts. The Eastern & Southern Africa Regional Initiative on Traditional Medicine and AIDS was borne out of this assessment. It convened a regional consultation in May 2003, which produced a series of proposed standards around six main themes related to traditional medicine and HIV/AIDS: the systematic evaluation of traditional remedies; spiritual aspects of healing; HIV prevention and care; processing and packaging of traditional remedies; protection of indigenous knowledge; and intellectual property rights related to traditional health systems. These standards, summarized in this paper, will be incorporated into programs on traditional medicine and HIV/AIDS by various implementers in the region. A number of strategies to test and implement these recommendations are also defined.

Acquired Immunodeficiency Syndrome↗
PubMedDate not supplied

The essential drugs concept is needed now more than ever.

The debate on access to essential medicines, which was live in the late 1970s and 1980s when strong pressure from public health advocates led the pharmaceutical industry to accept the concept, is now back on the international health policy agenda. Currently, the Essential Drugs List (EDL) forms an integral part of national drug policies in 146 countries, guiding the selection of drugs on the basis of public health relevance, efficacy, safety and cost. The essential medicines debate is back on the agenda as part of the access to medicines debate. The Trade Related Aspects on Intellectual Property Rights agreement has caused concern among public health advocates in terms of its impact on access to essential medicines. This article reviews the concept of essential medicines in the light of the changing political context and recommends that the EDL is supported as a crucial public policy tool in all countries.

Advertising↗
PubMed2002

Medical innovation and institutional interdependence: rethinking university-industry connections.

University-industry research collaborations have been key to a continued high degree of technological innovation in medicine. Recently, however, critical questions have been posed about the potential negative aspects of highly productive means of encouraging innovation. Concerns center on blurring roles between academic research and the commercial world and the implications of universities' newfound readiness to benefit financially from their intellectual property. The roles of both parties are often inadequately captured by considering members of university faculties as single-mindedly devoted to the advancement of fundamental knowledge and industrial firms as mere developers of university research. Rather, medical innovation depends on extensive interactions between universities and industry, with knowledge and technology transfer flowing in both directions. These interactions have had important public health and economic benefits. Yet, there is a risk to the university-industry relationship if the cultural and ethical principles of one partner overwhelm those of the other. Therefore, universities and industry need to maximize the upsides of collaboration and minimize the downsides by means of internal organizational change as well as formation of new models of collaboration, such as intellectual partnerships or virtual research organizations. This article reviews the numerous institutional patterns of innovation and draws implications for organizational and public policies.

Biomedical Research↗
PubMed1999

Auto-disable syringes for immunization: issues in technology transfer.

WHO and its partners recommend the use of auto-disable syringes, "bundled" with the supply of vaccines when donor dollars are used, in all mass immunization campaigns, and also strongly advocate their use in routine immunization programmes. Because of the relatively high price of auto-disable syringes, WHO's Technical Network for Logistics in Health recommends that activities be initiated to encourage the transfer of production technology for these syringes as a means of promoting their use and enhancing access to the technology. The present article examines factors influencing technology transfer, including feasibility, corporate interest, cost, quality assurance, intellectual property considerations, and probable time frames for implementation. Technology transfer activities are likely to be complex and difficult, and may not result in lower prices for syringes. Guidelines are offered on technology transfer initiatives for auto-disable syringes to ensure the quality of the product, the reliability of the supply, and the feasibility of the technology transfer activity itself.

Disposable Equipment↗
PubMed2002

Ethical, legal and economic issues raised by the use of human tissue in postgenomic research.

Ethical, legal and economic framework issues concerning human samples, genetic data and bioresources are rapidly evolving. In most cases, international standards have not been defined. National legislations on the use and exploitation of human sample collections differ widely. Legislations relating to intellectual property rights, access to database information for public or private bodies, of national or foreign origin, are similarly diverse. Importation and exportation rules, concerning in particular data protection, biosafety and protection of individual rights, have not always been defined. This article makes a short assessment of the legal, ethical and economic framework in selected EC countries (Germany, France and UK), and compares them with the conditions in the USA. On the basis of the information collected, it is obvious that the use of human cells, tissues and organs in medical research has to be considered as a global, worldwide question. Such use has profound ethical, cultural and economic consequences not only in the country of origin, but also globally. Biotechnology and pharmaceutical companies conducting research with human samples are facing different framework conditions in the area of data protection, policy measures, economic support, exportation, etc., that already influence trade activities and investments of such firms at the international level. Over the 3 last years, a trend towards harmonization can be recognized: the World Health Organization has recognized the problems of postgenomic medical research as a priority. The OECD has created a taskforce on centers for biological resources. Biobanks are a common theme of the French and the German National Ethic Councils. A lack of international harmonization and consistency might not only present a challenge to biotechnology and pharmaceutical companies, but can also endanger the goals the laws and regulations seek to achieve.

Culture Techniques↗
PubMed2005

Harnessing genomics to improve health in the Eastern Mediterranean Region - an executive course in genomics policy.

BACKGROUND: While innovations in medicine, science and technology have resulted in improved health and quality of life for many people, the benefits of modern medicine continue to elude millions of people in many parts of the world. To assess the potential of genomics to address health needs in EMR, the World Health Organization's Eastern Mediterranean Regional Office and the University of Toronto Joint Centre for Bioethics jointly organized a Genomics and Public Health Policy Executive Course, held September 20th-23rd, 2003, in Muscat, Oman. The 4-day course was sponsored by WHO-EMRO with additional support from the Canadian Program in Genomics and Global Health. The overall objective of the course was to collectively explore how to best harness genomics to improve health in the region. This article presents the course findings and recommendations for genomics policy in EMR. METHODS: The course brought together senior representatives from academia, biotechnology companies, regulatory bodies, media, voluntary, and legal organizations to engage in discussion. Topics covered included scientific advances in genomics, followed by innovations in business models, public sector perspectives, ethics, legal issues and national innovation systems. RESULTS: A set of recommendations, summarized below, was formulated for the Regional Office, the Member States and for individuals.* Advocacy for genomics and biotechnology for political leadership;* Networking between member states to share information, expertise, training, and regional cooperation in biotechnology; coordination of national surveys for assessment of health biotechnology innovation systems, science capacity, government policies, legislation and regulations, intellectual property policies, private sector activity;* Creation in each member country of an effective National Body on genomics, biotechnology and health to:- formulate national biotechnology strategies- raise biotechnology awareness- encourage teaching and training of biotechnology- devise integration of biotechnology within national health systems. CONCLUSION: The recommendations provide the basis for a road map for EMR to take steps to harness biotechnology for better and more equitable health. As a result of these recommendations, health ministers from the region, at the 50th Regional Committee Meeting held in October 2003, have urged Member States to establish national bodies of biotechnology to formulate a strategic vision for developing biotechnology in the service of the region's health. These efforts promise to raise the profile of genomics in EMR and increase regional cooperation in this exciting new field.

Editorial↗