September 25, 2014
Mr Juncker has replied by letter to the concerns of the health sector on the transfer of medicines from DG Sanco to DG Enterprise/Internal Market. The letter says that one of the main priorities of the new commission is to create “A Deeper and Fairer Internal Market with a Strengthened Industrial Base” and to that end to establish a new DG for legislation for internal market of products and service (apart from financial services) and including “medicinal products”.
The transfer is therefore part of a wider process to strengthen the European pharmaceutical industry. DG Enterprise will be responsible for strengthening the European pharmaceutical industry AND for medicines, medicines regulation, medicines safety, and the European Medicines Agency.
This is exactly what the health sector opposes.
There is not some large transfer of responsibility for products and services to the new DG Enterprise/Internal Market. Medicines (or “medicinal products,” as the letter describes them) are the ONLY goods for which responsibility is transferred to DG Enterprise.
Food law is a key element of internal market laws but is not transferred to the new super Enterprise DG although that DG is responsible for strengthening the European food industry. Why were medicines singled out for transfer?
(There was a time, as it happens, when DG Enterprise was responsible for much food law but the Prodi Commission transferred that task to a new DG Sanco, so as to separate responsibility for food law from responsibility for promoting the food industry. The second Barosso Commission did the same for medicines.)
General product safety is the responsibility of the new Justice/Consumers DG. This is also an important element in internal market legislation but is not transferred to DG Enterprise. Again, why only medicines?
The letter does say that all proposals for decisions on medicines will be prepared “jointly” (my emphasis) by DG Sanco and DG Enterprise. This may be significant in bureaucratic terms but less so in practical terms. At best, DG Sanco will remain the junior partner , if indeed it can be called a partner at all. With medicines assigned to DG Enterprise in the Commission internal organigramme, DG Sanco will not have the resources to build up the knowledge base, expertise, experience, research data, and ongoing daily interactions with the world of medicines to match those of DG Enterprise.
Remember Glenis Willmott’s experience as rapporteur for the regulation revising the Clinical Trials Directives;
“When I was negotiating the transparency laws for clinical trial results, it was DG Enterprise that wanted to water the rules down”. Now it is DG Enterprise which will responsible for implementing that regulation.
(On a wider level, Commission approval is required for all aspects of the transparency policy of the European Medicines and it is the Commission and not the agency that has the final decision on the authorisation of medicines.)
I can think of one excuse for this letter. When there is not a good reason for a decision, or when you do not want to admit the real reason, the only option is to put forward bad reasons.
Given that medicines are singled out for transfer to DG Enterprise, given that this is exactly and precisely what the industry demanded, given that the decision overturns a reform of only five years duration, and given that DG Enterprise is also responsible for strengthening the European pharmaceutical industry I would say something I don’t think I have ever said before. Unless this decision is reversed, patients and consumers cannot have confidence in the regulation of medicines at EU level. ENDAuthor : Jim Murray