The EU has decided to launch a consultation programme intended to make the European pharmaceutical industry more competitive.
The Commission believes that implementation and interpretation of Community legislation by Member States is creating barriers to the free movement of medicines, and reducing competitiveness, especially of small and medium-sized enterprises, without always bringing public health benefits. There is also scope for better regulation, says the Commission.
Across the EU there are different national pricing and reimbursement schemes, leading to market fragmentation, parallel trade, disparities in prices and time-to-market delays. In certain countries, companies are deterred from putting drugs on the market because of excessive regulation or low pricing. There is a lack of transparency and harmonisation with regard to pricing, reimbursement and relative effectiveness remains a challenge.
Recent cases in which drugs have had to be withdrawn because of the emergence of harmful side effects, and the disastrous TGN1412 clinical trial in the UK, demonstrate that the safety of medicines remains a major EU internal market issue.
The existence of multiple and sometimes inefficient pharmacovigilance requirements in the EU needs to be addressed. The challenge is to strengthen and rationalise drug safety monitoring, while avoiding unnecessary requirements that would impair patients’ access to treatments.
The Commission also wants to investigate safety issues around parallel trade and counterfeiting of medicines.
Another trend shaping the EU pharmaceutical sector is the increasingly proactive role of patients. The Commission says that patients require better access to quality information. Currently, drug companies are barred from making such information available.
Finally, new technologies, therapies and medicines are emerging. This includes in particular regenerative medicine, more personalised treatments, and the development of nanomedicines.
These developments are already affecting the business strategy of EU companies, the industry structure, with the formation of small, specialist start-ups, the design of clinical trials, and the way medicines are prescribed.
Against this background, the Commission has launched a broad public debate on the future of pharmaceuticals in Europe, to get stakeholders’ views on the key challenges of the sector and how to tackle them.
Contributions are invited from all stakeholders dealing with medicines for human use. This includes patients’ organisations, Member States authorities, international bodies, industry associations and individual companies, healthcare professionals, or any other person or legal entity interested in this field. Stakeholders who are not established within the EU are equally invited to comment. Comments from SMEs are especially welcome.
Contributions should be sent by e-mail to [email protected] before 12 October.