Pharmaceuticals Policy and Law - Volume 13, issue 1-2
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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: The European Parliament and the Council of the European Union have recently adopted Regulation (EU) No 1235/2010^1 and Directive 2010/84/EU^2 concerning the pharmacovigilance of medicinal products for human use. These and other European institutions have been laying down rules on the subject for decades, but this is the first time they have enacted legislation specifically and (almost) exclusively regulating pharmacovigilance. This paper analyzes the context, causes, objectives, key…points and challenges of the new legislation.
Abstract: An increasing number of European countries use pharmacoeconomic evaluations of innovative medicines in their pricing and reimbursement decisions, e.g. France, the Netherlands, Belgium, U.K., Sweden and Germany. These studies may be conducted by using different techniques from varying viewpoints. However, they do not take into account the wider effects of cost cutting measures upon the availability of medical alternatives and further pharmaceutical research. Firstly, it is not known in advance whether an…innovative substance will be a blockbuster or a me-too drug. Moreover, due to different side effects, it is necessary to have more than one drug for specific indications. Secondly, health care policy is inseparable from economic policy in shaping the industry structure of the pharmaceutical industry. Lower spending for drugs may lead to less research in certain indications. Furthermore, lower spending for drugs which have been invented and developed within Europe may result in deprivation of pharmaceutical and medical know-how, for example, for conducting clinical studies. It is, thus, necessary to also include these effects in pharmacoeconomic evaluations.
Keywords: Pharmacoeconomic studies, pharmaceutical industry, health care system, research and development
Abstract: The interplay of the exclusive right conferred by patents to innovative pharmaceutical products and the regulatory rules for their marketing approval seemed to be solved 1993 with the creation of the Supplementary Protection Certificate, which allowed patent owners to extend on a timely basis their exclusive rights upon expiration of the patent, thus mitigating, at least partially, the negative effects of lengthy administrative marketing approvals. The development of this new IP right through the years has…revealed deficiencies in the system and resulted in a rich body of European case law, notably as to what constitutes a 'basic patent', 'marketing authorisation' or 'product', which provide key concepts for the requirements of the Supplementary Protection Certificate. The successive amendments of the Regulation concerning the Supplementary Protection Certificate for Medicinal Products include the extension of the original duration of this right upon new requirements concerning the inclusion of paediatric plans in the marketing authorisation which form the basis of a SPC application.
Keywords: Supplementary protection certificate, basic patent, marketing authorisation, european union, pharmaceuticals, medicinal product, active ingredients, regulation
Abstract: The conclusions of The House of Commons Science and Technology Committee report examining the policy on homeopathy, it is a careful and thoughtful analysis. It is the best example of the responsibility of the Parliaments for protects the health right of the patients. His proposals will be valid for all the countries and will be global principle for regulation. It is unacceptable for the National Health Authorities to license placebo products conferring upon them…some of the status of medicines. Even if medical claims on labels are prohibited, the official licensing itself lends direct credibility to a product. Licensing paves the way for retail in pharmacies and consequently the patient's view of the credibility of homeopathy may be further enhanced. The Governments runs the risk of endorsing homeopathy as an efficacious system of medicine. It is time to break this chain. Homeopathy should not be funded and the Agencies of Medicaments should stop licensing homeopathic products. Not changes the actual situation will lose the credibility of the Health Institutions. It is one more political inconsistency.
Abstract: After more then four decades, the regulation of pharmaceuticals still is an evolving and much discussed topic within Europe from a political and economic perspective. Even though the benefits of regulatory harmonization remain uncontested, the constant review and evaluation of the sector may raise public concerns regarding regulatory performance. If regulatory 0experts still see the need for improving existing regulatory provisions, there is reason to believe that the current system does not live up to its…expectations. An assessment of regulatory effectiveness, depicting the degree of goal attainment, provides a systematic answer to such questions. Drawing on the regulatory framework, the governance and the outcomes of the regulatory process the development of regulatory effectiveness since the beginnings of European regulation in the sector is discussed. While a continuous improvement from the perspective of effectiveness is traceable throughout time, some issues impeding the performance of the regulatory regime remain. Even though the pharmaceutical package may help to mitigate some of the identified problems, additional efforts will be necessary to finally strengthen the effectiveness of European pharmaceutical regulation and public health.
Keywords: European pharmaceutical policy, regulatory quality, effectiveness of regulation