On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
New German Law Proposed Regarding Anti-Corruption in the Healthcare Sector
Current anti-corruption provisions in the German Criminal Code prohibit corruptive agreements with respect to granting an undue benefit or offering a bribe to public officials and to employed HCPs, but have gaps with regard to other HCPs. For example, they do not cover activities involving the principal of a commercial practice or business (e.g., a self-resident physician or a pharmacist) or other HCPs who are not public officials and/or not employees. This could lead to inconsistent results; for example, granting an undue benefit to an employee of a HCP in private practice may be prohibited, but not doing so with regard to the HCP himself/herself. Although other German laws, such as the German Health Care Advertising Act (Heilmittelwerbegesetz – "HWG"), may prohibit such activities, the criminal laws do not.
If the draft law is adopted, pharmaceutical and medical device companies will face greater risk in their interactions with HCPs who are self-employed or work at privately held or funded hospitals, or other medical personnel (e.g., some nurses and pharmacists) who are involved in providing public health care. For detailed information on the proposed legislation, as well as updates on revisions that may arise during the legislative process, please contact the Hogan Lovells attorney with whom you work.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017