Healthy Skepticism Library item: 11489

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: media release

Towards Centralised and Transparent Marketing Authorisations for all Medicines
The Medicines in Europe Forum/The International Society of Drug Bulletins 2007 Sep 7

Full text: This is the Medicines in Europe Forum and ISDB Contribution to the public consultation organised by EU Commission Enterprise Directorate on national marketing authorisation variations (September 2007) (1), following a preliminary proposal (October 2006) (2). ● We welcome the European Commission’s initiative aimed at clarifying the legislative framework for marketing authorisation variations within the European Union. But further harmonization of marketing authorisation procedures is needed, and these procedures must also be made more transparent in order to ensure that they guarantee both patients’ best interests and fairness for competing drug companies. Marketing authorisation procedures in the European Union are so heterogeneous that it is difficult, and sometimes impossible, for European citizens (particularly healthcare professionals and patient organizations) to understand what is going on. Too many types of easier and faster authorisations. Drugs that circulate within the EU can be authorised through the centralised procedure, or a national procedure, or the mutual recognition (decentralised) procedure following national authorisation. Easier and faster authorisations have accumulated over the years, making this general framework even more complex. They include accelerated procedures, marketing authorisation granted in exceptional circumstances, conditional, simplified authorisation, paediatric authorisation, and orphan drug status. National characteristics such as authorisation for temporary use and approval for “temporary therapeutic protocols” in some Member States, are also largely exploited by drug companies seeking faster market access for their products. The heterogeneity of national marketing authorisation conditions (despite harmonized rules), especially for marketing authorisations variations – the subject of this consultation – generates conflicts that have to be resolved through referral procedures. And even when an agreement is reached the decisions are slow to be enacted. The situation is therefore highly confusing, to the point where it can even be difficult to identify the different indications in which a particular drug is approved depending on the European countries. Still too opaque. Secrecy still pervades marketing authorisation at all levels of the system. Decisions taken by drug regulatory agencies are not systematically upheld by readily accessible assessment reports. EMEA does post European Public Assessment Reports (EPAR) online, but their quality has always been highly variable (even though it is improving), and EPARs for extensions of indications are sometimes released several months after the fact (3,4). National agencies do not publish all their assessment reports (NPAR), and when they do they rarely translate them, even into English. European citizens often have no reliable way of knowing whether a company fulfils the undertakings it make in exchange for a non-standard marketing authorisation procedure (5). Instead they have to keep an eye on medical journals for the results of post-market studies, cohort follow-up studies, etc. And when it comes to adverse effects, secrecy is still the rule in 2007, as we pointed out, once again, during the consultation on the European pharmacovigilance system (6). Towards a transparent and centralised procedure for all. Harmonization of administrative requirements and criteria for extensions of national marketing authorisations would be a step in the right direction. This would avoid unnecessary complications for applicants, healthcare professionals and patients, and might also reduce the need for referral. However, further reform is needed to create a system that is fair and understandable for all stakeholders, that promotes appropriate drug use, and that bolsters the credibility of the European regulatory system. Throughout the adoption procedure for Directive 2004/27/EC (modifying Directive 2001/83/EC), the Medicines in Europe Forum pleaded for true harmonization, most notably through a broadening of the centralised procedure’s field of application; gradual but nonetheless rapid suppression of the national procedure and of the mutual recognition procedure; optimization of expertise and resources, with Member State expertise being reallocated to the centralised procedure; and strict assessment (and 5-year reassessment) of marketing applications based on common and clinically relevant criteria (7). Post-market follow-up data collected in each Member State, and especially pharmacovigilance data, should be gathered, analysed and serve as the basis for valid decisions applicable throughout the European Union. This plea in favour of the centralised procedure was heard by the European Parliament: as of 20 May 2008, the centralised procedure will be obligatory for 7 categories of drugs, namely those indicated in AIDS, cancer, neurodegenerative disorders, diabetes, rare diseases, autoimmune diseases, and viral infections (8). But there was also strong lobbying in favour of the mutual recognition procedure, which is judged more “flexible” by drug companies and more directly lucrative for those regulatory agencies that are most often chosen as the “reference Member State” (9). As a result, the mutual recognition procedure and the decentralised procedure are still widely used, and it is a source of confusion and sterile competition between national agencies. And, while there are some steps towards greater transparency, it still remains highly secretive in 2007. Whatever legislative and regulatory measures are taken in order to harmonize variations of national marketing authorisations, the Medicines in Europe Forum calls for real efforts to ensure full harmonization of the European system for approving new drugs and indications, and for existing transparency requirements be respected in practice. The quality and safety of medicinal products requires a certain incompressible level of administrative constraints to be imposed on manufacturers; any attempt to go beyond this limit in the EU would jeopardize citizens’ health. The use of the mutual recognition or decentralised procedure, currently predominant, is prejudicial to the global efficiency of the EU medicines market and undermines the safety of European citizens. A harmonized system, which creates a level playing field for competing companies and offers EU citizens concrete guarantees of safety, is the only option for a world-class system.

Contacts: – Maria Font, ISDB President maria.font@ulss20.verona.it – Florence Vandevelde, MiEF Coordinator coordinationMiEF@gmail.com

References
1- European Commission – Enterprise and Industry Directorate General “Better regulation of pharmaceuticals: towards a simpler, clearer and more flexible framework on variations” Public Consultation ; 10 July 2007. Site internet
http://ec.europa.eu/enterprise/pharmaceuticals/varreg/variations_issue_paper_20061020.pdf: 12 pages.
2- European Commission – Enterprise and Industry Directorate General “Better regulation of pharmaceuticals: towards a simpler, clearer and more flexible framework on variations” Issue paper ; 20 October 2006. Site internet
http://ec.europa.eu/enterprise/pharmaceuticals/varreg/variations_issue_paper_20061020.pdf: 16 pages.
3- Abbasi K and Herxheimer A “The European Medicines Evaluation Agency : open to criticism” BMJ 1998 ; 317 : 898.
4- ISDB European Group “European Medicines Evaluation Agency” ISDB Newsletter 2001; 15 (1): 11-13.
5- Prescrire Editorial Staff “Post-market studies: broken promises” Prescrire Int 2007; 16 (89): 123.
6- Prescrire Editorial Staff “La revue Prescrire Contribution to Consultation on Pharmacovigilance in the EU” Prescrire Int 2006; 15 (84): 149-153.
7- Prescrire Rédaction “Pour une réglementation qui réponde aux besoins élémentaires de santé publique” Rev Prescrire 2002 ; 22 (230) : 544.
8- “ Regulation (EC) N° 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency “ Official Journal of the European Union 30 April 2004: L 136/1 – L 136/33.
9- Prescrire Rédaction “Les dangers de la procédure d’AMM par reconnaissance mutuelle” Rev Prescrire 2002; 22 (230): 54