Improving availability of medicinal products in the EU
By Nand de Herd, former President of ECHAMP (European Coaltion on Homeopatic and Anthroposophic Medicinal Products)
Recent surveys in France, Czech Republic, Spain, Italy, Germany and Belgium, among others, show a growing demand of citizens for CAM healthcare provision, not only in general practice, but also for specialists in hospitals and in pharmacies. This increasingly brings into question the offer from healthcare providers and products.
The European institutions have already taken an interest in topics such as health inequalities and cross border; they are now interested in knowing more about the availability of medicinal products for citizens and prescribers.
In 2007, the Heads of Medicines Agencies (HMA) identified a number of availability concerns which they published in a report Availability of Human Medicinal Products.
More recently, in 2011, the European Parliament published a study Differences in costs of and access to pharmaceutical products in the EU.
Now the European Commission is preparing the launch of a study on the availability of medicinal products for human use in the EU, including non-prescription medicines and also herbal and homeopathic medicines. The European Commission has appointed the London based consultancy ‘Matrix Insight’ to do the background work for this study. The specifications for the study are described in a tender document published by the Executive Agency for Health and Consumers.
The Commission’s expectations are clearly expressed in one sentence of the tender document: Information collected should not be limited to any specific category of medicinal products, but should include information on innovative and generic products, prescription only and over-the-counter, as well as cover different therapeutic areas.’
Furthermore, the tender says that the expected results should give a comprehensive factual analysis of the problem and its roots, and an assessment of existing tools which the Commission can use, if appropriate, as a basis to develop policy options in this area.
It is clear that the conditions for the availability of medicines cannot be linked exclusively to the EU regulatory environment for pharmaceuticals, and that the lack of availability is typically the result of different factors. Economic circumstances, pricing and reimbursement regimes or existing national distribution systems play a major role. However, this report will obviously focus as well on the regulatory aspects related to authorization procedures and their implementation.
It will be the first study by the European Commission on the problems of availability of all medicinal products in the EU as well as on the drivers of these problems. The report should serve as a basis for the Commission to consider possible future policy initiatives.
Untill now ECHAMP is working on a comprehensive report as regards problems of availability of homeopathic and anthroposophic medicinal products in the EU. This report, supported by two independent surveys executed by PricewaterhouseCoopers (PwC), includes a lot of data on demand, regulatory status and availability concerns of these medicinal products. ECHAMP will make this report available as soon as possible to the European Commission and to Matrix Insight.