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
✕

EuropaBio: Revision of the EU general pharmaceuticals legislation for a healthier tomorrow

22/12/2021
PRESS RELEASE
Brussels, December 22, 2021 – yesterday, EuropaBio, the European Association for Bioindustries, submitted responses to the open consultation on the revision of the EU general pharmaceuticals legislation, and the targeted survey supporting the revision. Our members highlighted their belief that leveraging the full potential of biotechnology is fundamental to reposition the EU as a global leader in cutting-edge medicine R&D.

“In the context of global challenges and accelerated science, the ambition of the pharmaceutical legislative revision should be to transform the EU’s strong research base into breakthrough innovation to better address the health needs of Europeans and to regain EU’s global leadership as a home for R&D and cutting-edge industry.", says Bernard J. Grimm, Healthcare Biotechnology Director.

To truly capitalise on the potential biotechnology offers, the EU needs a streamlined, flexible and coherent regulatory system. A focus on increasing the attractiveness of the EU as a region to conduct first-launches of new treatments is key. Our members spoke to the need for competitive assessment timelines and iterative scientific advice, in particular for SMEs. To support this, adequate resourcing and funding of EMA is necessary to keep pace with evolving regulatory approaches globally, such as the increased use of RWE.

EuropaBio members seek to make their medicines available to as many patients, and in as many countries, as early as possible. However, a plethora of issues relating to the accessibility of medicines lie outside industry and EU control, such as national pricing and reimbursement policies that depend on Member State health systems’ organisation and administration. We believe improving coordination between EMA and Member States can accelerate patient access to new advances in health innovation at EU level. More effective pricing and reimbursement systems in Member States, that avoid duplication of HTA and payer requirements, would lower administrative burden for SMEs.

For EU life sciences and biotechnology companies to prosper a competitive environment conducive to furthering clinical research needs to be in place. Proper incentivisation of R&D, in addition to upholding necessary intellectual property protections, allows the development of biotechnology and encourages investment and risk-taking for innovation.

The last comprehensive review of the pharmaceutical legislation was tabled almost 20 years ago, since then, healthcare has rapidly advanced thanks to advances in biotechnological R&D. The future of medicine is evolving from traditional one-size-fits-all medical care to personalised medicine tailored to the genomic, molecular, and lifestyle characteristics of individual patients. A future-driven review of the pharmaceutical legislation is needed to bring the next generation of biotechnology medicines to patients across Europe.

EuropaBio: Revision of the EU general pharmaceuticals legislation for a healthier tomorrow


Download
Share
Alexandra Simionca
Alexandra Simionca

Related posts

22/05/2025

Adisseo joins EuropaBio: Feeding Animals Sustainably Around the World


Read more
21/05/2025

Ensuring Biotech Integration in the Single Market


Read more
10/04/2025

EU biotechnology competitiveness for the future; high level dialogue with EVP Séjourné


Read more

Important links

  • Adisseo joins EuropaBio: Feeding Animals Sustainably Around the World
  • Ensuring Biotech Integration in the Single Market

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.