To evaluate European law-making and to reduce restrictive rules to the necessary minimum are the objectives of the initiative ‘Better Regulation’ which has been adopted by the European Commission. Better Regulation means: less quantity, more quality – achieved by more transparent decision-making processes and improved impact assessment.
The European Commission intends to evaluate existing law in terms of its up-to-dateness and efficacy by the ‘Regulatory Fitness and Performance Programme’ (REFIT). In order to increase transparency and quality in future European law-making processes, the Better Regulation initiative places special focus on the impact assessment by the European Commission as well as consultation processes with stakeholders, i.e. relevant players of the society and economy.
Increased quality and acceptance by involvement of stakeholders
Systematic involvement of stakeholders ensures that the broad expertise of all concerned players is taken into account. Furthermore, it leads to smoother implementation and a higher degree of acceptance. The more detailed the input from stakeholders, the more tailored the impact assessment of law-making initiatives. Active involvement of stakeholders in the decision-making process may contribute to higher quality of results, reduced costs and reduced workload on the European Commission. Therefore, the Better Regulation initiative belongs to the priorities of the European Commission.
Reduce burden on small and medium-sized pharmaceutical manufacturers
Small and medium-sized enterprises suffer particularly from the consequences of legislative over- and misregulation. They normally have the least resources to cope with regulatory requirements. Hence, these companies may benefit to a great extent from the efforts of the European Commission.
As the pharmaceutical sector is strongly regulated, better law-making in this area could especially produce returns for this industry. Consequently, the trend of imposing more and more regulatory requirements on pharmaceutical manufacturers in recent years could be halted. European legislation should focus on the necessary protection of patients and consumers and ensure that no further hurdles emerge which might jeopardize the access of patients to medicines. Together with its European umbrella association AESGP (‘Association of the European Self-Medication Industry’), BAH will continue to argue for well-balanced and efficient European legislation.