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The Implications Of The New EU HTA Regulation For Companies

Joint Clinical Assessments Will Become A Key Part Of The New Environment

 
• By Alexander Natz

Legal and industry expert Alexander Natz sets out key questions and answers to help companies prepare for new EU regulations on health technology assessments, one of the biggest developments to affect the pharmaceutical industry in over a decade.

Increased cooperation on HTA across the EU aims to help patients, payers and business • Source: Alamy

Regulation (EU) 2021/2282 on health technology assessment (HTA) is now in force and will bring important and wide-reaching changes that pharmaceutical companies need to understand.

About the Author

Alexander Natz is secretary general of the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), a European trade body representing small to medium-sized innovative pharma, biotech and medical technology companies

Arguably the most important implication of the regulation is the introduction of EU-level joint clinical assessments (JCAs) that will start to become applicable in a few years’ time. These joint assessments are essentially relative effectiveness assessments that will be conducted by designated national HTA experts at the EU level

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