Welcome to Justin Stindt Consultants. Our consultants are experts in market access activities in the European markets such as Germany, France, UK, Italy, Spain and Switzerland. JSC can also guide you through market access in Portugal, Sweden, Norway, Finland, Denmark, Ireland, Austria, BeNeLux and further EU markets, together with our network of local vendors. Our agency supports pharma, biotech and medtech companies e.g. with Pricing & Reimbursement strategies, advice on Pricing & Reimbursement pathways, Health Technology Appraisal scientific advice discussions, Pricing & Reimbursement dossiers and the organization of Advisory Boards.
Market Access Europe – Essential to access the EU market for pharma, biotech and medtech
Europe encompasses a diverse range of countries and healthcare systems, offering a vast healthcare market with a combined population of over 740 million people. Health spending across European countries varies, with an average healthcare expenditure of around 9.7% of GDP according to the OECD in 2022. However, it is important to note that healthcare expenditure and systems can significantly differ across individual European countries due to various factors such as economic conditions, policy priorities, and population health needs.
While many biotech companies start with a focus on the EU-5 (France, Germany, Italy, Spain and the UK), there are plans to create stronger incentives to address all EU markets
Navigating Pharmaceutical Market Access in Europe: Regulatory, Reimbursement, and Pricing Dynamics
Within Europe, each country has its own regulatory frameworks and reimbursement pathways for pharmaceuticals. Through the centralized procedure, the European Medicines Agency (EMA) evaluates the safety, efficacy, and quality of medicines intended for the European market. The reimbursement of medicines is typically determined by national health authorities or insurance systems. The criteria used by authorities for health technology assessment (HTA) and pricing and reimbursement vary across markets. Price negotiations between companies and reimbursement authorities play a crucial role in establishing pricing and reimbursement agreements. Several EU markets have special regulations for orphan drugs, cell & gene therapies and Advanced Therapy Medicinal Products (ATMPs). Our agency has experience with all these types of products and supports manufacturers with EU Market Access.
Emerging Trends in European Health Technology Assessment: The HTACG and the HTAR Implementation from 2025
Additionally, European collaboration initiatives, such as the Member State Coordination Group on HTA (HTACG), aim to harmonize and facilitate the exchange of HTA information among European countries. EU Regulation on Health Technology Assessment (HTAR) will progressively be implemented from 2025 onwards but the exact process and extent of adoption on a national level remains to be determined. This Coordination Group will conduct Joint Clinical Assessments and Joint Scientific Consultations from 2025 onwards.
With a vast population, diverse healthcare systems, and evolving regulatory frameworks, Europe presents both challenges and prospects for companies seeking market access, collaboration, and successful product launches across multiple countries.
Justin Stindt Consultants is your agency to support you with Market Access in Europe
Justin Stindt Consultants is your consulting firm with experts who have extensive experience in diverse Market Access activities across European countries. Our consultancy has helped many clients by engaging the local authorities (such as the G-BA, NICE, AEMPS, HAS, AIFA) for scientific advice meetings and develop benefit assessment dossiers. Our consultants also support price negotiations. For medical devices and digital health apps, our agency, as service provider, supports dossiers and negotiations.
Contact our consultants today to learn how our agency can tailor our services to meet your unique needs to enable Market Access in European markets.
Learn more about our expertise in the following market access domains
- Pricing & Reimbursement strategies / Pricing strategy
- Strategic advice on Pricing & Reimbursement (pathways)
- Health Technology Appraisal scientific advice discussions
- JSC, EU
- HTA France, FR
- HTA Germany, DE
- HTA United Kingdom (England, Wales, Scotland, Northern Ireland), UK
- Pricing & Reimbursement dossiers
- JCA, EU
- P&R France, FR
- P&R Germany, DE
- P&R Italy, IT
- P&R Spain, ES
- P&R United Kingdom (England, Wales, Scotland, Northern Ireland), UK
- Advisory Boards
Market Access services for Pharma and Biotech in Europe
Case studies for European market
- Support entire French Market Access process
- ATU Feasibility Assessment
- HAS early dialogue meeting
