Market Access
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EMA/HTA parallel consultation platform
On 30 June 2017 the EMA and EUnetHTA launched the new EMA/HTA parallel consultation platform. The new guidance replaces the former draft best practice guide as of publication date and has been developed from the experience gained with the SEED…
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EMA publishes report on parallel Scientific Advice
EMA published a report on the pilot on its parallel regulatory-health technology assessment scientific advice with a Best Practice Guide. Background: Since 2010, the EMA has initiated a pilot project of parallel HTA-regulatory scientific advice,…
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Fast-track drug approval for unmet medical needs in Europe
The European Medicines Agency (EMA) has revised its guidelines on the implementation of accelerated assessment and conditional marketing authorisation, two key tools in the European legislation to accelerate patients’ access to medicines that address unmet…
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Latest EMA-HTA meeting minutes
The EMA has published the minutes of its face-to-face meeting with the EUnetHTA (European Network for Health Technology Assessment) which was held on 8 May 2015. There were in-depth discussions on various items during this…
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Monitoring of Patent Settlements in Europe
Patent settlement agreements are commercial agreements to settle patent-related disputes, e.g. questions of patent infringement or patent validity. They are concluded in the context of patent disputes, opposition procedures or litigation where no final…
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Orphan Drugs and Ultra-orphan, NICE tries to find a balance.
Earlier this month the UK Bio-Industry Association published a report detailing their recommendations for the new ultra-orphan medicines evaluation framework for ultra-orphan drugs currently being developed by the UK’s Nation Institute for Health and Care…
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Changing the rules of the game. EMA and EUnetHTA’s new 3 year plan.
The collaboration between regulatory and technology assessment bodies has the potential to change the approach to product development and approval in Europe. This collaboration, that was started in 2008, is likely to have an impact on stakeholders in…
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On Access to Medicines…from WHO
Expenditure on medicines accounts for a major proportion of health costs in developing countries. This means that access to treatment is heavily dependent on the availability of affordable medicines. Although trade in medicines is…
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Pay-for-delay settlements under scrutiny
Drug manufacturers urged to reconsider patent dispute strategies in response to ground-breaking EU and US rulings. On 19 June the EC published its first decision on “pay for delay” settlements, levying fines of €93 million on…
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Marketing in more complex healthcare systems
By Simon Ruini, London Marketing strategies have evolved as a result of more complex healthcare systems. Payer’s restrictions, value based pricing, increased safety surveillance and ongoing regulatory support mandates a bird’s eye view strategy as…