LOGOLOGOLOGOLOGO
  • About us
    • What we do
    • Who we are
      • Governance
      • Staff
      • Vacancies
  • Members
    • EuropaBio Members
    • About Membership
  • How we work
    • Healthcare Biotechnology Council
      • Patient BioForum
      • Study – Impact of the EU’s General Pharmaceutical Legislation
    • Industrial Biotechnology Council
      • EFIB
      • Microorganisms
    • National Associations Council
    • SME Platform
    • Biomanufacturing Platform
      • Biotechnology in our Lives
  • Activities
    • 25 Years of Innovation
    • The EU Biotech Act
    • European Biotech Week
    • EU Projects
      • PRIMED Project
      • APROVALS Project
  • News & Events
    • News
    • Events
  • Library
Become a member
✕

Joint Pharmaceutical Industry Statement on the Commission’s Proposal for a Regulation on Health Technology Assessment (HTA)

28/06/2018
POSITION PAPER

Joint Pharmaceutical Industry Statement on the Commission’s Proposal for a Regulation on Health Technology Assessment (HTA)

The pharmaceutical industry represented by AESGP, EFPIA, EUCOPE, EuropaBio, Medicines for Europe and PPTA – henceforth referred to as ‘the pharmaceutical industry’ – generally welcomes the European Commission (EC)’s Proposal for a Regulation on HTA. We understand the scope of the joint clinical assessments foreseen in the proposal is limited to medicinal products subject to the centralised marketing authorisation, and exempting generic, biosimilar and non-prescription medicines.

We believe that EU cooperation on joint clinical assessments and joint scientific consultations has the potential to contribute to expedite patients’ access to medicines in Europe. It is a unique opportunity for greater alignment on clinical evidence generation requirements, ensuring consistency, transparency and synergies in clinical assessments by Member States and evidence that is relevant for Europe. It can also reduce the burden faced by companies, which is particularly important for the competitiveness of small-scale biopharmaceutical companies active in Europe.

For the future system to work, we agree it is crucial that the joint clinical assessment replaces the equivalent step in the national HTA process. However as experienced in EUnetHTA, in a purely voluntary framework joint clinical assessment reports are not sufficiently used at the Member State level. The pharmaceutical industry therefore strongly supports the requirement to apply and not repeat joint clinical assessment reports at the national level (article 8). Member States should of course continue to be solely responsible for drawing conclusions on the value of the health technologies concerned as part of national appraisal processes and should retain full competence when it comes to national pricing and reimbursement decision-making.

We believe that strengthening the process and methodology framework within the main body of the Regulation can contribute to a balanced debate on the merits of the Commission Proposal on HTA. In particular, a scoping meeting between the health technology developer and the assessors, the outcomes of which would be endorsed by the Coordination Group, would ensure that all Member States’ requirements are appropriately reflected in the assessment, and hence avoid controversies downstream. Such scoping would also contribute to the timely availability of reports at marketing authorisation in order to avoid any delays in national decision-making. It also needs to be clarified that methodologies that will support joint clinical assessment will build on existing EUnetHTA methods, be up to date with scientific development and be regularly reviewed; methodologies and evidence also need to be sufficiently flexible in order to ensure a level playing field for different types of medicines, including medicines for rare diseases that have limitations resulting in unavoidable evidential uncertainty.

We look forward to a constructive dialogue with all stakeholders, including patients, healthcare providers and representatives from Member States and EU institutions to ensure that the Commission Proposal achieves our shared goal of improving the availability of innovative treatments and therapies for patients across Europe.

Download the file below to read the full statement.

Joint Statement on the Proposal for a Regulation on HTA


Download
2018_06_H_PP_Joint-industry-statement-HTADownload
Share
Alexandra Simionca
Alexandra Simionca

Related posts

07/07/2025

EuropaBio Position on the Critical Medicines Act


Read more
03/07/2025

Life Sciences Strategy Embraces Biotech for Global Impact


Read more
26/06/2025

Health Biomanufacturing: Feedstock for Preparedness and Resilience


Read more

Important links

  • EuropaBio Position on the Critical Medicines Act
  • Life Sciences Strategy Embraces Biotech for Global Impact

Categories in our Newsroom

EBIO-white

EuropaBio represents corporate and associate members across sectors, plus national and regional biotechnology associations which, in turn, represent over 5000 biotech companies, 4600 out of them are SMEs.

Contact us

Extra links

Members
Staff
Privacy policy
Legal & cookies
Events
Newsroom

Become a member

Media pack

© 2025 Europabio. All Rights Reserved. Designed by EYAS
Become a member

Algal Omega 3

Algal Omega-3 is an innovative feed product for aquaculture. It reduces the impact on climate change by 30-40% compared to fish oil and saves 60 tons of wild fish for every ton of Algal Omega-3 used.

Cheese

Cheese is a vegetarian product thanks to biotechnology. Biotechnology is also essential to produce lactose- or cholesterol-free cheese, as well as alternative proteins.

Clothes

Clothes made from alternative fibres produced by microorganisms can be 8x stronger than steel, 100% recyclable, biodegradable and replace fossil-fuel based or resource-intensive textiles.

Vitamin B2

The biomanufacturing of Vitamin B2 led to the reduction of 75% of fossil raw materials and 50% operating costs, compared to the chemical process. Vitamin B2 is used in the food, feed or healthcare sectors.

Detergents

Enzymes and biosurfactancts are alternative ingredients that improve the performance of detergents, while leading to water and energy savings and reductions in CO2 emissions and water toxicity.

Insulin

Insulin is one of the most widely known biopharmaceutical. Biotechnology revolutionised its manufacturing process and led to the development of new types of insulin through r-DNA technology.