Pharmaceuticals Policy and Law - Volume 13, issue 1-2

Article Type: Other

DOI: 10.3233/PPL-2011-0308

Citation: Pharmaceuticals, Policy and Law, vol. 13, no. 1-2, pp. 1-5, 2011

Authors: Doménech, Gabriel

Article Type: Research Article

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. Show more

DOI: 10.3233/PPL-2011-0309

Citation: Pharmaceuticals, Policy and Law, vol. 13, no. 1-2, pp. 7-27, 2011

Authors: Oehlrich, Marcus

Article Type: Research Article

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. Show more

Keywords: Pharmacoeconomic studies, pharmaceutical industry, health care system, research and development

DOI: 10.3233/PPL-2011-0313

Citation: Pharmaceuticals, Policy and Law, vol. 13, no. 1-2, pp. 29-40, 2011

Authors: Cabezas, M.D. | Piqueras, A.J.

Article Type: Research Article

DOI: 10.3233/PPL-2011-0312

Citation: Pharmaceuticals, Policy and Law, vol. 13, no. 1-2, pp. 41-55, 2011

Authors: Guzmán, José López

Article Type: Research Article

DOI: 10.3233/PPL-2011-0314

Citation: Pharmaceuticals, Policy and Law, vol. 13, no. 1-2, pp. 57-60, 2011

Authors: de la Rosa, Fidel Porcuna

Article Type: Research Article

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. Show more

Keywords: Supplementary protection certificate, basic patent, marketing authorisation, european union, pharmaceuticals, medicinal product, active ingredients, regulation

DOI: 10.3233/PPL-2011-0310

Citation: Pharmaceuticals, Policy and Law, vol. 13, no. 1-2, pp. 61-71, 2011

Authors: Mallol, J.

Article Type: Research Article

DOI: 10.3233/PPL-2011-0311

Citation: Pharmaceuticals, Policy and Law, vol. 13, no. 1-2, pp. 73-77, 2011

Authors: Valverde, José Luis

Article Type: Research Article

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. Show more

DOI: 10.3233/PPL-2011-0315

Citation: Pharmaceuticals, Policy and Law, vol. 13, no. 1-2, pp. 79-90, 2011

Authors: Bauschke, Rafael

Article Type: Research Article

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. Show more

Keywords: European pharmaceutical policy, regulatory quality, effectiveness of regulation

DOI: 10.3233/PPL-2011-0316

Citation: Pharmaceuticals, Policy and Law, vol. 13, no. 1-2, pp. 91-114, 2011