Pharmaceuticals Policy and Law - Volume 11, 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 rights and well-being of children involved in clinical research in Europe should be assured by the respect of ethical considerations and legal rules. Specific provisions are included in the Directive 2001/20/EC (CT-Dir) aimed at providing a homogeneous ethical and legal context to perform clinical trials in Europe. The TEDDY Network of Excellence carried out a "Survey on the ethical and legal frameworks existing in Europe for paediatric clinical trials" to examine the measures…enforced by Member States to implement the CT-Dir and other relevant ethical norms. The results showed that many differences exist in the protection of children enrolled in clinical trials. Such differences are especially due to a non-coordinated implementation of the Directive's Article 4 and a lack of public awareness on ethical issues in this field. The recently approved 'Ethical considerations for clinical trials on medicinal products conducted with the paediatric population' should speed up the implementation of an 'ad hoc set of ethical rules' and increase the level of minors' protection. Nevertheless, in lack of 'binding rules', a coordination at European level is still needed. Public initiatives aiming at promoting in-depth debates have to be supported in order to encourage this process of coordination.
Keywords: TEDDY, ethics, paediatrics, clinical trials, informed consent, children assent
Abstract: The mission statement of the TEDDY project is to promote the research on the safe and effective use of drugs in children and to expand and integrate the knowledge and to build research capacity in the drug development for children. One of the activities of WP1 – pharmacoepidemiology was to study the frequency and type of ADR reporting in children. For this analysis, we used data from the Uppsala Monitoring Centre (WHO collaborating Centre for…International Drug Monitoring). All reports on ADRs in children (< 18 years), sent to the monitoring centre between 2000 and 2004 were analysed. This report contains the first results on the ADR reporting in children. Within this report, we mainly focus on the occurrence of ADRs with a fatal outcome. In further analysis, we will further explore the association between causal related deaths and the use of specific drugs.
Keywords: TEDDY, ADRs report, pharmacoepidemiology, children, WHO
Abstract: The European Medicines Agency has expressed 50 positive opinions recommending the granting of a marketing authorisation for an orphan medicinal product since the Regulation on orphan medicinal products (OMPs) entered into force in 2000. However, OMPs authorised at EU level are not always available at Member States (MS) level. We developed and distributed a questionnaire to collect information on the availability of 20 OMPs authorised before October 2006. The questionnaire included questions on the date of…national market availability; the possibility of pre-marketing access programme; the distribution channel, the availability of a reimbursement policy. Twelve MS provided information: Austria, Belgium, Czech Republic, Denmark, Estonia, Finland, Hungary, Ireland, Italy, Latvia, Slovakia and UK. Results demonstrate that the availability of OMPs varies greatly among the 12 MS considered and market availability delays are highly variable. OMPs are often expensive drugs and the different MS reimbursement policies are hindering access to OMPs. Data show that since 2000 the number of OMPs has increased however issues including costs and reimbursement policies at MS level represent major barriers to real OMPs accessibility. This is a critical situation that deserves attention because of the evident inequalities that do exist with regards to OMPs accessibility among MS.