Position papers 2016
Big data – the analysis of large quantities of data – has become a top issue in the healthcare sector. The sector association of the biotechnology industry, the Biotechnologie-Industrie-Organisation Deutschland (BIO Deutschland), therefore welcomes the fact that German lawmakers, through the Law for Secure Digital Communication and Applications in Healthcare (e-Health Law), aim to seize the opportunities that the digital age offers the healthcare sector.
In late July, the Federal Ministry of Health (BMG) submitted a draft bill aimed at improving the supply of medicinal products in the statutory health insurance funds (AM-VSG). BIO Deutschland has drafted a position paper focused on this legislation and also made clear at a BMG hearing in August that introducing a turnover ceiling in the first year after approval would hinder the development of innovative therapies.
The Federal Ministry of Health (BMG) held discussions with experts on the rules contained in theministerial draft bill on the Fourth Act Amending the Regulations on Medicinal Products and Other Regulations (Medicinal Products Act Amendment) that pertain to the implementation of the EU regulation governing the conducting and supervision of clinical trials in Europe. It became clear during the hearing that the changes should go into effect as early as this summer.