Commission launches consultation on pharmaceuticals
The European Commission has launched a consultation on the future of pharmaceuticals for human use in Europe, as a part of its programme to improve the regulatory, non-regulatory and research, technology and development framework for pharmaceuticals. In an explanatory note, the Commission highlights three major challenges impacting the pharmaceutical sector in Europe: the globalisation of the sector; the smooth functioning of the internal market; and advances in science and technology. On globalisation, the Commission notes that 'due to structural factors which go beyond the pharmaceutical sector (e.g. labour costs), the centre of gravity for worldwide R&D [research and development] investment in the field is gradually moving to the United States and Asia.' Regarding the internal market, the Commission notes that there are still obstacles to the free movement of medicines. Furthermore, the Commission notes that the safety of medicines is a major internal market issues. 'Recent analysis has demonstrated the existence of multiple and sometimes inefficient requirements as regards pharmacovigilance in the EU,' the Commission writes. 'The challenge is thus to strengthen and rationalise drug safety monitoring, while avoiding unnecessary requirements that would impair patients' access to treatments.' Another trend affecting the pharmaceutical sector is the increasingly proactive role of patients regarding their health, and the Commission notes that patients need better access to quality information. Finally, the Commission identifies advances in sciences and technology such as regenerative medicine, more personalised treatments and the development of nanomedicines, which are all affecting the way medicines are tested and eventually prescribed. Key questions asked by the Commission concern other challenges to the industry, such as what measure could be implemented to ensure the safety of medicines supplied to the EU, how to improve Europe's international competitiveness and how the EU regulatory framework can be applied to emerging technologies.