Generic Medicines (generic + medicine)

Distribution by Scientific Domains


Selected Abstracts


TRIPS-Plus Implications for Access to Medicines in Developing Countries: Lessons from Jordan,United States Free Trade Agreement

THE JOURNAL OF WORLD INTELLECTUAL PROPERTY, Issue 6 2007
Hamed El-Said
Since the establishment of the World Trade Organization (WTO) in 1995 and implementation of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) as a result, the United States (US) sought to impose still higher levels of intellectual property rights on developing countries, a phenomenon that is commonly known today as TRIPS-Plus. The Jordan,US FTA, signed in 2001, contains several TRIPS-Plus rules that restrict the poor's access to medicines, and is today touted by US officials and the US Trade Representative (USTR) as a success, and providing a wide range of benefits. These benefits not only include a higher growth rate, but also more specific benefits to the pharmaceutical sector in particular, such as an improved ability to develop generic medicine and engage in new innovative research, as well as increasing the presence of and collaboration with multinational drug makers. This article analyzes in detail the TRIPS-Plus provisions of the Jordan,US FTA. It challenges the claims that the FTA brings general and specific benefits to developing countries, and provides fresh evidence which strongly suggests that benefits from the Jordan,US FTA have been largely exaggerated while the costs underestimated. [source]


TRIPs and Public Health: The Doha Declaration and Africa

DEVELOPMENT POLICY REVIEW, Issue 1 2007
Stine Jessen Haakonsson
The Doha Declaration on the TRIPs Agreement and Public Health (2001), aimed at improving access to medicines, especially for HIV/AIDS, malaria and tuberculosis in developing and least developed countries, has not yet been used for compulsory licences to import generic medicines or for expanding production for export to poor countries. By analysing HIV/AIDS treatment in Uganda, this article discusses the variety of TRIPs-related channels for ensuring drugs for domestic treatment, and argues that emphasising the restrictive nature of TRIPs provisions fails to grasp the scale of the obstacles involved. Lack of domestic resources leaves African countries dependent on donor financing, which in turn constrains their ability to exploit international trade provisions. [source]


Consumers' views on generic medicines: A review of the literature

INTERNATIONAL JOURNAL OF PHARMACY PRACTICE, Issue 2 2009
Mohamed A. A. Hassali
Abstract Objectives To review the literature on consumers' knowledge, attitudes and opinions of the use of generic medicines. Method A narrative review of studies conducted from 1970 to 2008 on consumers' perceptions and views towards generic medicines was performed. An extensive literature search was undertaken using indexing services available at the authors' institution library. The following keywords were used for the search: brand, generic, multisource, medications, medicines, drugs, pharmaceuticals and consumers, customers, and patients. Electronic databases searched were Medline, Inside Web, ISI Web of Knowledge, Science Direct, Springer Link, JSTOR, Proquest, Ebsco Host and Google Scholar. These electronic databases were searched for full text papers published in English from 1970 to October 2008. Key findings Twenty studies were identified. Eleven were from the USA, four were from Europe, two were from Canada and one each was from Australia, Brazil and Malaysia. In general, consumers showed mixed reactions towards the use of generic medicines. This was evident from the divergence of views observed by country development level, consumers' socioeconomic characteristics, drug product characteristics, pharmaceutical reimbursement system, policy environment, contact with health care professionals, past experience with medications, and knowledge of the seriousness of a medical condition. Conclusions Patient confidence and knowledge pertaining to generic medicines use have increased over the past four decades, especially in developed countries. Mass educational efforts, financial incentives, and greater communication among patients and health care professionals were seen as major drivers to the uptake of generic medicines among consumers. [source]


Biosimilars: pharmacovigilance and risk management,

PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 7 2010
Leyre Zuņiga Ph.D.
Abstract Biosimilars cannot be authorised based on the same requirements that apply to generic medicines. Despite the fact that the biosimilar and reference drug can show similar efficacy, the biosimilar may exhibit different safety profile in terms of nature, seriousness or incidence of adverse reactions. However, the data from pre-authorisation clinical studies normally are insufficient to identify all potential differences. Therefore, clinical safety of similar biological medicinal products must be monitored closely on an ongoing basis during the post-approval phase including continued risk,benefit assessment. The biosimilar applicant must provide the European Medicines Agency (EMEA) with a risk management plan (EU-RMP) and pharmacovigilance programme with its application, including a description of the potential safety issues associated with the similar biological medicinal product that may be a result of differences in the manufacturing process from the reference biologic. The most critical safety concern relating to biopharmaceuticals (including biosimilars) is immunogenicity. Risk management applies scientifically based methodologies to identify, assess, communicate and minimise risk throughout a drug's life cycle so as to establish and maintain a favourable benefit,risk profile in patients. The risk management plan for biosimilars should focus on heightens the pharmacovigilance measures, identify immunogenicity risk and implement special post-marketing surveillance. Although International Nonproprietary Names (INNs) served as a useful tool in worldwide pharmacovigilance, for biologicals they should not be relied upon as the only means of product identification. Biologicals should always be commercialised with a brand name or the INN plus the manufacturer's name. Copyright Š 2010 John Wiley & Sons, Ltd. [source]