Archives: Pharmaceutical companies

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MHRA grants second scientific opinion as part of the Early Access to Medicines Scheme

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a second positive scientific opinion as part of the Early Access to Medicines Scheme (EAMS).  EAMS is a UK specific scheme that supports earlier access of unlicensed medicines in patients with seriously debilitating or life threatening conditions where there is an unmet medical need. … Continue Reading

European Commission Published Non-Confidential Version of Servier Decision

On 14 July 2015, the European Commission (the “Commission”) published the preliminary non-confidential version of its decision in the Servier case, one year after the decision was issued.  This is the second key Commission decision, after Lundbeck, on reverse payment patent settlement agreements. In Servier, the Commission went further than in Lundbeck and in its … Continue Reading

The Italian Competition Authority launches a sector inquiry in relation to vaccines for human use

On 27 May 2015, the Italian Competition Authority (ICA) issued a decision launching a sector inquiry into the supply of vaccines for human use. The ICA has stated that it has launched the sector inquiry because of: the importance of vaccines in terms of health care costs borne by the Italian National Health Service (over … Continue Reading

German Exemptions from Mandatory Rebates for Pharma Companies Are in Line with EU State Aid Rules

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 … Continue Reading
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