The European Commission (the Commission) confirmed on 27 March 2015 that a German scheme exempting pharmaceutical companies from mandatory rebates is in line with EU State aid rules. The Commission concluded that the scheme facilitated price freezes on certain medicines, which in turn allows the costs of the public health system to be kept under control.

Council Directive 89/105/EEC allows Member States to introduce price freezes on pharmaceutical products. Article 4(2) of the Directive states that derogations from price freezes can be justified for “particular reasons”. Based on these provisions, Germany introduced a mandatory manufacturer’s rebate of 16% on certain prescription medicines sold to public sickness funds and private health insurers between 1 August 2010 and 31 December 2013. Also, under the Article 4(2) exemption, Germany set up a system of derogations for companies whose financial viability would be threatened by the rebate.
Continue Reading German Exemptions from Mandatory Rebates for Pharma Companies Are in Line with EU State Aid Rules

On 4 February 2015, the German Ministry of Justice published a new draft law specifically aimed to combat corruption in the healthcare sector. Key element of the draft legislation will be a newly defined criminal offence that will be inserted as a new Section 299a of the German Criminal Code (StGB). This new criminal offence sanctions active and passive bribery of a wide range of healthcare professionals – not only of medical doctors.

The envisioned new § 299a StGB would significantly sharpen the German anti-corruption laws as far as interactions between life sciences companies with medical doctors and other healthcare professionals are concerned. The criminal culpability would apply to both the healthcare professional that accepts a bribe and the company representative that pays a bribe.
Continue Reading Germany Headed to Stricter Criminal Laws Against “Corruption In The Healthcare Sector”