European Generic Medicines Association Calls For Changes In The Regulatory Framework For Generic Med
Europe - Generic Drugs - Feb 05 2010
The European Generic Medicines Association (EGA)'s Vision 2015 calls for changes in the regulatory framework for generic and biosimilar medicines in order to create a globally competitive generic industry, increase patient access to affordable quality medicines and ensure sustainable healthcare in Europe. According to Greg Perry, director general of the EGA, 'Generic medicines are one of the most competitive sectors in Europe, accounting for almost 50% of all the medicines dispensed, bringing combined savings of between EUR25-30bn (US$34-41bn) yearly. And yet numerous hurdles crop up as a result of anti-competitive activities that create unnecessary delays in the development and introduction of new generic medicines.'
| Slow Growth |
| EU Generic Medicines Market |
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| Source: BMI |
Via the Vision 2015, the EGA has called for 5 key changes. This includes the introduction of tax and R&D incentives for generic and biosimilar research and clinical trials in order to encourage innovation within the industry; the elimination of barriers to generic competition by restricting third party intervention in procedures that enable anti-competitive strategies and unjustifiable delays in market authorisation; the implementation of an improved regulatory environment by building on the current success of the European authorisation systems including streamlining the Decentralised Procedure (DCP) and better adaptation of the Centralised Procedure (CP) to generic medicines; increasing information on generic and biosimilar medicines to patients and health care professionals across Europe in order to create a more positive image of the generic medicines sector; and creating a single - more harmonious - market for generic drugs in Europe to facilitate the more efficient and less-costly approval of generic medicines.
BMI welcomes the EGA's focus on creating a regulatory framework that will support the growth of the region's generic medicines market. With regards to the European Union, BMI calculates that the generic drugs sector experienced a 2004-2009 compound annual growth rate (CAGR) of 9.23%, rising from US$25.25bn to US$39.26bn. In 2004, generic medicines accounted for 23.31% of the EU's total drug market and by 2009 comprised 25.81%. We believe that the slow growth in the market share of the low-value generic medicines highlights the need for changes in the regulatory environment as well as the importance of educating consumers about generic medicines. BMI believes the upcoming patent cliff and the resultant patent expiries of a number of the world's top-selling drugs will push growth in the generic medicines market in Europe, though it is vital that changes such as those in the Vison 2015 are realised to assist medicine approvals and consumption.