Archives: Healthcare system

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NHS England Publishes Draft Commercial Framework for Medicines

NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be finalized later … Continue Reading

European Data Protection Board releases Guidance on Intersection of the GDPR and the Clinical Trials Regulation

The European Data Protection Board (“Board”) released an opinion on January 23, 2019, on the intersection between the EU General Data Protection Regulation (“GDPR”) and the Clinical Trials Regulation (“CTR”).  The opinion considers a Q&A on this topic prepared by the European Commission’s Directorate General for Health.  The Directorate General decided to create this Q&A … Continue Reading

Exploring the EU Horizon for Pharma

The EU pharmaceutical industry landscape is in significant flux. There are many pressures to provide new therapies and to make them available more early and for as many qualifying patients as possible. In that context, the industry model and the role of exclusivity rights as a tool to stimulate innovation are being discussed. At the … 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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