The economics of new product launches and access to pharmaceutical products in the EU: A perspective on the EC’s proposed reform of the EU pharmaceutical legislation

One goal of the European Commission's proposed reform to existing regulations is to increase patient access to innovative medicines across the European Union. We describe the economic impact of this policy change. Because of the incentives created by other policies, particularly external reference pricing and parallel trade, these reforms may have an adverse impact on competition in the pharmaceutical sector and reduce the attractiveness of Europe as an incubator for pharmaceutical innovation. Changes to bargaining power are likely to favour large, established firms. These reforms also increase the uncertainty of the length of market exclusivity, potentially undermining innovation incentives.