The European Commission has launched a “broad public debate” on the future of pharmaceuticals in Europe, and is inviting all stakeholders, and particularly small and medium-sized enterprises (SMEs) in the sector, to contribute.

The Commission says the debate will help in its aims to improve the framework for human-use pharmaceuticals within the European Union in the face of the following new public health, scientific and economic challenges:

– globalisation of the sector and increasing internationalisation of the value chain: globalisation brings both challenges and opportunities, says the Commission, eg, the emergence of worldwide health threats, such as the increasing number of counterfeit medicines or pandemic influenza, while the internationalisation of the value chain and the rise of new players in the global competition provide compelling grounds to intensify international cooperation. Two objectives must be met: better protection of the health of EU citizens, and strengthening of European companies’ competitiveness by removing regulatory and non-regulatory barriers which impede access to foreign markets, and also ensuring fair international competition.

Globalisation also means that, due to structural factors, which go beyond the pharmaceutical sector (eg labour costs), the “centre of gravity” for worldwide R&D investment in the field is gradually moving to the USA and Asia. Europe should strive to regain territory it covered for most of the 20th century, when it was the home of pharmaceutical innovation, says the Commission;

– the smooth functioning of the internal market in a widening EU: member states’ implementation and interpretation of EU legislation still create obstacles to the free movement of medicines, while overburdening requirements also affect competitiveness, especially for SMEs, without always bringing public health benefits. There is scope for better regulation, for example in variations to existing authorisations, and possibly also for clinical trials, says the Commission. Also, different national pricing and reimbursement schemes still coexist, leading to market fragmentation, parallel trade, price disparities and time-to-market delays; because of administrative requirements and poor economic rewards, medicines are not even made available in certain countries. The lack of transparency and harmonisation with regard to pricing, reimbursement and relative effectiveness remains a challenge, it emphasises.

Moreover, the safety of medicines remains a major EU internal market issue, with the continued existence of multiple and sometimes inefficient pharmacovigilance requirements. The challenge is thus to strengthen and rationalise drug safety monitoring, while avoiding unnecessary requirements that impair patients’ access to treatments, it says.

The Commission’s services are also analysing the patient safety aspects of medicines in the distribution chain, including those related to parallel trade and counterfeiting, it says, while another trend shaping the sector is the increasingly proactive role of patients, who require better access to quality information. However, the information provided currently varies between member states, and media such as the Internet may not always provide reliable data. At present, the information which the industry has on its medicines cannot always be made available to patients , it comments; and

– emerging advances in science and technology, in particular regenerative medicine, personalised treatments and nanomedicines. These developments are already affecting EU companies’ business strategies, industry structure - with the creation of highly innovative SMEs - the design of clinical trials and the way medicines are prescribed. These elements have to be translated gradually into the EU pharmaceutical framework of the 21st century, says the Commission.

It is inviting contributions to the debate from all stakeholders dealing with human-use medicines, for example patient organisations, member states authorities, international bodies, industry associations and individual companies (innovative, generic and self-medication sectors), and healthcare professionals, including those who are not established within the EU. Comments from SMEs in the pharmaceutical sector are especially sought.

Contributions should be sent by e-mail to nicolas.rossignol@ec.europa.eu before October 12, 2007. They will be made publicly available on the Commission’s Pharmaceuticals website once the consultation period is over, unless a specific request for confidentiality is made.

Following the public debate, says the Commission, it intends to address a Communication to the Council of the European Union and to the European Parliament on the future of the EU single market in human-use pharmaceuticals, outlining its vision and strategy for the sector, as well as concrete action items. The Communication will build on this consultation and will outline how its outcome was taken into account.