EA in the EU 21 Nov 2022

EA in the EU

Most EU member states have special programmes which facilitate early patient access to new medicines through a national authority. These early access programmes are known by different names in different countries — CUP’s or Compassionate Use Programmes, Special Access Programmes and NPP’s or Named Patient Programmes — all terms which vary geographically and are often used interchangeably. Whatever name they come under, however, they all mean one thing — they make compassionate use medicines available to a patient prior to authorisation and commercial launch in their country.

Most importantly, they mean hope for patients who have serious, specialised needs who may have felt they were in a hopeless situation.

Europe currently has in the region of over 100 early and managed access, compassionate use and named patient programmes running across the continent — not an easy task in any instance due to the multi-layered regulatory frameworks laid down by the EMA and those specific to each country.

There is no one-size fits all system in the EU — individual states may differ greatly from each other and some countries have more barriers in place to EAP’s than others. Most countries have EAP’s in place, but only a few have programmes allowing cohorts of patients rather than individuals benefit from early access. It’s necessary across the block for stakeholders such as health professionals, patients and their representative organisations, pharmaceutical companies and policy makers to keep abreast of legislation and be informed of processes that facilitate or give access to innovative medicines early.

Across the EU, some CUP’s are free and some have costs. Charging for a medical product in a compassionate use setting is prohibited in some countries — in fact, the producing company may need to pay running and approval costs. In others, it’s left at the discretion of the pharmaceutical company whether or not to charge and in others it can be split between company and patient.

France currently has the fewest barriers. The Pioneer in Europe for EAP’s, and the only country where systematic review and funding of EAP’s exists through the ATU system which is social security-funded and covers both NPP’s and CPU’s.

At the other end of the scale however are countries such as Greece and Portugal which don’t have the infrastructure in place to support EAP’s making the barriers to implementation much higher.

Implementing early access programmes has multifold benefits to both patients and pharmaceutical companies. They give patients the chance for treatment that they might not otherwise have been able to access, and they increase the research opportunities for pharma companies, furnishing them with valuable information and helping to speed and smooth the path of new medicines to market.

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