Market Access consultancy for EU, UK & Switzerland

To place a medicinal product on the EU market, the product must obtain a marketing authorisation. For centrally authorised products, this is done via European Medicines Agency (EMA). There are also national or decentralised procedures handled by each Member State’s national competent authority.

Even with authorisation, getting access to patients typically requires  pricing and reimbursement strategies at national level – authorisation alone does not guarantee that the drug will be reimbursed or used.

An expert can guide you through the choice of authorisation route (centralised vs national), prepare the dossier, and help anticipate national reimbursement requirements – thus increasing the likelihood of both approval and commercial access.

While authorisation is handled by EMA or national competent authorities, pricing and reimbursement decisions are made at national (or sometimes regional) level. Decisions are based on health-technology assessment (HTA), national pricing rules, and reimbursement policies, which vary per country.

A consultant with market access expertise can map relevant authorities across EU markets, identify submission requirements and deadlines, and tailor the reimbursement strategy to each country’s regulatory and payer framework.

HTA and reimbursement dossiers are typically required after regulatory approval to secure payer coverage. They evaluate therapeutic value, cost-effectiveness, budget impact, and comparative effectiveness. Many EU countries require such assessments before listing the product for reimbursement.

Without favourable HTA outcomes, even approved products may remain off-market from a practical patient access perspective, or face restricted uptake.

An experienced consultant can design and compile HTA submissions, help generate clinical and economic evidence (or real-world evidence), and present a value proposition aligned with payer expectations – thereby improving opportunities for successful reimbursement.

Though regulatory authorisation (e.g., via EMA) can cover the whole EU, pricing, reimbursement, and health system organization remain national competencies. Member States differ widely in regulation, budget constraints, payer requirements, willingness to pay, and speed of decision-making.

Additionally, pricing strategies (e.g., reference pricing, compulsory price reductions when generics/biosimilars enter) vary significantly by country, affecting a company’s commercial viability differently across markets.

Consultants can perform comparative market access analysis across EU countries, recommend optimal launch sequencing, propose tailored pricing strategies, and forecast commercial viability – helping sponsors prioritise markets and tailor their approach.