Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Brexit: Possible regulatory impacts on the pharmaceutical industry and marketing authorisation holders in Europe ***

Anna Wehage (Abschlußjahr: 2017)

Summary
Language: English
On 29 March 2017, the United Kingdom (UK) decided to leave the European Union (EU), and the UK government triggered Article 50 of the Treaty on the EU, officially starting the two-year period of negotiation before the UK exits the EU. It must be assumed that the process, known as ‘Brexit’, will lead to profound changes to the broadly harmonised field of medicinal products. This highlights an urgent need for guidance regarding different concerned regulatory topics. The primary goal in the uncertain environment of Brexit is to avoid a delay in drug approvals.
To decide on a strategy regarding Brexit, without prejudice to the outcome of the withdrawal negotiations, this thesis is principally focused on the assumption that the UK will become a third country as of 30 March 2019, when it ceases its membership in the European single market and acquires full control of its own law-making. The thesis aims to give an overview of various regulatory aspects to be considered when making a strategic decision on the consequences of Brexit. In order make a proposal for possible solutions, it presents regulatory collaboration models and their potential to be a template for future co-operation of regulatory bodies with the MHRA. The approach to creating a guideline close the CADREAC procedure reflects the experiences that have been made in this voluntary procedure with respect to EU enlargement. A simple European approach for a guideline can hence minimise the complexity of the process and is a basis and incentive for further discussion.
As a result, the analysis of the different fields demonstrates a lack of regulatory guidance. Regulatory initiatives in the EU are urgently needed to overcome the issue of inadequate information for guidance on Brexit. With a view to the tasks of marketing authorisation holders, the outcome is that they will need to consider carefully how they will manage their products. In conclusion, the present thesis can be used to support a regulatory affairs manager in answering upcoming questions and furthermore gives advice how to develop a strategy on Brexit considering and focusing on the companies’ interests. This shall enable the regulatory affairs departments in Europe to provide an adequate evaluation that is necessary for strategic decisions of the company.
Pages: 79