Pharmaceuticals Policy and Law - Volume 16, issue 3-4
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The new international review,
Pharmaceuticals Policy and Law, appears with the aim of studying and evaluating the
legal status of medicinal products in the European Union, and its implications in other markets such as the USA and Japan, without neglecting the specific problems of developing countries.
Pharmaceuticals Policy and Law intends to participate in the process of world convergence of pharmaceutical legislation helped by a network of academic centers specializing in pharmaceutical law, without omitting a scientific, economic and social approach to medicinal products.
The specificity of medicinal products conditions their legal status. Legislation regulating other goods cannot be applied to them. To begin with, they are the result of scientific and technical innovation. Research policies determine their progress. The pharmaceutical industry is, by nature, multinational. But, next to these global trends, different traditions still remain at a national level. Within the EU, barriers to free trade in medicinal products still remain despite more than thirty years of harmonisation. The social dimension of medicinal products is complex and very significant in the preoccupations of our societies. Patenting is essential but not sufficient. The life-cycle of medicinal products is protected by professional responsibility, required in the general concept of health safety. It is important to remember their ethical dimension, including research and innovation in new fields such as genetic manipulation and biotechnology, which requires social consent to preserve human dignity and fundamental rights.
Abstract: Latin America is a diverse, multi-coloured and dynamic region; boast the highest life expectancy among developing regions. In Latin America persistent social exclusion and inequities in wealth distribution and in access and use of services are reflected in health outcomes. With its population reaching 600 million people in 2011, Latin American pharmaceutical sales were at $62.9 billion. LA's pharmaceutical market represents approximately 25% of global pharmaceutical sales. As a developing market, Latin America is quite…complicated and diverse in terms of regulatory, reimbursement, market, demographic, and political characteristics. The harmonization of pharmaceutical regulation has been initiated in conjunction with the creation of regional free trade zones. Five main free trade zones are developing: North American Free Trade Agreement (NAFTA); MERCOSUR; Central America; Andean Area; and The Caribbean Community. Regulatory frameworks overall have improved as a result of free trade and intellectual property agreements. Regulatory enforcement bodies, quality investigators, proactive Good Clinical Practice (GCP) and policy development, have been cited as contributing to Latin America's explosive growth. Latin American countries are currently moving policies to support productive development and innovation. The local biotechnology industry is developing rapidly.
Keywords: Latin America, health care, pharmaceuticals, free trade, pharmaceuticals law, health policy
Abstract: The greatest challenges for pharmaceutical policies in Latin American countries are related to the objective of promoting access for their populations. Around two thirds of the spending on medicine in the region is financed by household incomes, with a strong regressive effect on their financing. For these reasons, the economic regulation tools for controlling spending and prices of medicines take on singular importance. The present article examines a set of measures implemented by the countries in…the region for the economic regulation of medicines centred on ensuring access to them, emphasizing those intended to control the prices of the pharmaceutical products and those oriented to moderating the spending on medicines in the health systems.
Keywords: Public policies, Latin America, access, medicines, medicine prices
Abstract: In the XIX and XX centuries, Latin American countries have experienced several changes on politics and economics, facing problems related to progress and growth, technological development, demographic transition, and the environment. In the 2010s this region presents a high level of health demands, which causes financial difficulties, especially in expenditures with medicines. In this scenario have emerged policies to regulate and harmonize the register of generic and similar products based on in vitro and in…vivo assays that support therapeutical equivalence and interchangeability, but heterogeneity is still observed, especially in terms of the assessment criteria and time from application until marketing authorization. Data obtained from the pharmaceutical market predict that this segment could reach USD 1,200 billion by 2016, mainly from market expansion in the leading emerging countries and from generics. The aim of this article is to present and discuss relevant aspects on bioequivalence, and biowaivers criteria, highlighting the different approaches adopted by the regional regulatory authorities in Latin America.
Keywords: Generic drugs, similar products, pharmaceutical regulation, bioequivalence, biowaivers, Latin American countries
Abstract: The pharmaceutical patent is the main figure use of Industrial Property; annually thousand of patents are applied in the world in order to protect pharmaceuticals. Of these just a few are new molecules; another part is variants as compositions, process of existing products, manufacturing process, or new indications. A patent gives public access to information, regarding new technologies for the purpose of stimulate innovation and contribute to economic growth, but in Latin America the…pharmaceutical patents have an incipient development. The purpose of this document is to provide a map of pharmaceutical patents and glimpse the situation in matter of patents in each country of Latin America since a practical way.
Keywords: México, Latin America, idea property, intellectual property, globalization, pharmaceutical companies, and patent
Abstract: Pharma R&D and the practical application of its results is challenging researchers, developers, professionals and policy makers in Latin America (LA) within the dramatic changes imposed by the world economic crisis. Five generations of R&D are widely recognized up to present time of Knowledge Management but LA countries are between the 2nd and 3rd generations. Non-wealthy countries cannot afford the Fifth Generation because the lack of managerial experience and both financial and human resources, and…the phenomenon that most of the present knowledge in advanced technologies are private-owned due to intellectual property rights, mainly in highly developed countries as USA, Japan and West Europe countries. However, a possibility exists for those LA countries in terms of the Second and Third Generations of R&D, where several key factors must be considered within the pharma sector. This work focuses on factors influencing Pharma R&D in LA like funding (in terms of GDP percentage), protective environment of national pharma sector, human resources, technological dependence from abroad, and managerial capacity in terms of the existence of R&D Strategic Planning and Project Portfolio as a way to set an innovative policy. Challenges and opportunities for the Pharma R&D in LA are discussed within the frame of the health sector.
Abstract: Herbal drugs for the prevention and treatment of various health disorders has been in practice a long time around the world. Generally the risk associated with herbal medicines is low, but some reports on serious reactions have been indicating the need of regulation and standards for these products. In this context, in the last five years, Brazilian Health Surveillance Agency (Anvisa) has been reframing some rules related to herbal medicines to assure quality, safety and efficacy…of these products. Therefore, the aim of this review is to present a historical set of legislation in order to understanding the currently context of legal rules regarding herbal medicines, showing the progress of herbal medicine regulation in Brazil.
Keywords: Herbal medicine, regulation, herbal drug harmonization, quality control
Abstract: The aim of this article is to characterize the procedure of judicialization to request drugs in a health plan for public employees in the Province of Santa Fe, corresponding to the south area, which coexists with other two subareas, public and private. These administrative and/or judicial procedures add to the idea that the "judicialization of health" obtains provision of drugs which are not considered by the health system. This research employs a qualitative methodology with analysis…of the content of drugs claims which were filed in appeals for protection by members. The sample includes 43 claims, and it was taken from a total of 209 claims for protection filed at the health plan's Legal Department during 2007–2013. Most of the claims for protection are related to high cost drugs. In most of the cases, the plaintiff obtains what they claim. As regards arguments in favor of the plaintiffs, some statements endorse forensic experts' reports, others highlight the need and urgency of having the requested drug available, and still others present the drug as orphan, unique or novel. In those cases which were favorable to the health plan, similar reasons were observed between the expert witnesses and the defendant party.
Keywords: Judicialization of health, drugs claims, medicalization, high cost drugs
Abstract: Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. Legal requirements for pharmacovigilance in some Latin American countries (Argentina, Brazil, Chile, Paraguay and Uruguay) were reviewed. Disparities in the legal framework among the countries are observed being those for marketing authorization holders one of the most evident. The active rol of the universities and drug information centers for/of pharmacovilance seems to be a positive common point.…Legal requirements regarding pharmacovigilance of biosimilar medicines, is still a point to be developed.
Keywords: Drug information services, product surveillance, postmarketing, pharmaceutical industry, public health
Abstract: The community pharmacy is an excellent place to identify those with undiagnosed diseases and refer them to their health professionals for treatment and continuing care. However the process of implementation of campaigns and activities to this end in community pharmacy has been slow and implemented by a pharmaceutical minority. It is crucial understand what are the barriers to participation, in order to design enabling actions to achieve greater adherence of pharmacists in these activities. In…order to identify and analyze the elements that hinder the dissemination, implementation and sustainability of pharmaceutical services aimed at the promotion and prevention, in the Argentine community pharmacies, a participatory diagnosis workshop was designed. Although pharmacists stressed that the absence of such professional activities entails a deterioration of pharmacists' image recognition in society, they expressed lack of constancy, economic incentive, specific training in the subject, time and physical space as own barriers to implementation thereof. Pharmacists think that these limitations are generally not taken into account when designing or planning campaigns. The university, must encourage interaction and involvement of different actors (patients, caregivers, family, health professionals) in order to engage them in solving the issues together and that they design activities according to local characteristics, to create actions and benefits that can be sustained in the long term.
Keywords: Community pharmacy services, health promotion, early diagnosis