Perspectives on Innovation Incentives on the EU Pharmaceutical Sector with Focus on EMA and Parallel Trade

The advances made in developing new medicinal products has resulted in that many illnesses and diseases typically leading to death are now treatable. As a result, life-expectancy and life quality has continuously increased in the EU. These should be good news for patients, but the problem is that not everyone can access these new medicines. Multiple barriers to access medicines have been identified and support for a more innovation friendly environment has been expressed. The thesis examines the incentives for Originator Pharmaceutical Companies’ to innovate new medicinal products in the light of parallel trade and European Medicine Agency’s (“EMA”) access to documents policy. The topic is important because the society relies on innovation made by these pharmaceutical companies, and therefore it is important to ensure that their incentives to engage in R&D are optimal. The market however does not by itself provide sufficient incentives for companies to innovate to a socially desirable extent. The regulator can respond to under-investment by introducing regulation that supports the emergence of innovations. Patents have traditionally been used by the regulator for this purpose, because they provide the innovator an exclusivity period, which enables the innovator to recoup the investments made in R&D. Medicinal products enjoy legal protection through patents, but as parallel trade of medicinal products is a legitimate business conduct in the EU due to the principle of regional exhaustion, Originator Pharmaceutical Companies claim that their incentives to innovate are reduced due to parallel trade. It can therefore be questioned whether patents are an appropriate tool to use on the pharmaceutical sector to support innovations? To further promote the emergence of innovations on the pharmaceutical sector, another mechanism was presented by the EMA, which is the main EU agency to provide scientific evaluation, supervision and safety monitoring on medicinal products developed by pharmaceutical companies that are sold in the EU. Because the provisions governing a medicinal product’s marketing authorisation procedure oblige companies to submit several documents to EMA, the agency holds great volumes of information in regard to data submitted by Originator Pharmaceutical Companies. Regulation 1049/2001 provides that any citizen of the Union has the right to access EU institutions’ documents and EMA’s internal “access to documents”-policy is based on the said regulation. According to the provisions in the regulation, access shall be refused if disclosure would undermine the protection of commercial interests, unless there exists an overriding public interest to disclose the documents. Such overriding public interest has in CJEU case law been interpreted to mean disclosure for the sake of democratic decision making process. In 2015, EMA widened the scope of its “access to documents”-policy to cover also documents relating to clinical data. Besides enabling public scrutiny to its decisions, the objective was also to enable the application of new knowledge in future research. It is however far from clear whether EMA de facto can base the new policy on Regulation 1049/2001 and disclose documents to promote scientific advancement, as Regulation 1049/2001 is traditionally interpreted to support disclosure and openness for enhanced transparency for the democratic decision making process. It is therefore reasonable to examine whether documents can be disclosed in the meaning of Regulation 1049/2001 to promote scientific advancement.

Grantor dc:publisher

Helsingin yliopisto

Year dc:date.issued

2018

Author dc:creator

• Malmi, Jade

Contributors dc:contributor

• Helsingin yliopisto, Oikeustieteellinen tiedekunta
• University of Helsinki, Faculty of Law
• Helsingfors universitet, Juridiska fakulteten

Language dc:language.iso

eng

Identifier URI

URN:NBN:fi:hulib-201802191280

OAI identifier oai:identifier

oai:helda.helsinki.fi:10138/232858