The granting of the community marketing authorisation (MA) does not mean a medicinal product is simultaneously available throughout all the European countries. In fact, following the MA granting, some aspects like the Price and Reimbursement (P&R) and other mandatory country-specific activities should be accounted for before placing the product on the market.

However, for medicinal products without a valid therapeutic alternative, Member States can nationally define procedures to access them in advance.

In Italy, the options to access a medicinal product before the MA, are the following:

• Named Patient request for importation from a country where the medicinal product has already a MA
  The concerned clinician must fill in a request for importation (“Nulla Osta”). The packs imported shall not exceed the amount necessary for the treatment of 90 days. The medicinal product is paid by the hospital; only if it is requested for hospital use it can be reimbursed by the NHS.
• Request for inclusion in the list of drugs fully reimbursed by the National Health System (NHS)
  The medicinal products can be included in the 648/96 list on the proposal of the Technical Scientific Committee (CTS) of the Italian Medicines Agency (AIFA), associations of patients, scientific societies, universities or public/private hospitals. Specific eligibility criteria need to be met. The medicinal products included in the list are fully reimbursed by the NHS and all patients eligible for treatment can access the treatment.
• Named Patient request for access to the AIFA 5% fund
  A funding request on a named patient basis should be submitted by the Concerned Region on behalf of the Centre of Reference or directly by the Centre. Specific eligibility criteria need to be met. Generally, this is the preferred option when the number of patients eligible for the treatment  is very low. The treatment costs are reimbursed by AIFA.
• Compassionate use
  The named patient requests for compassionate use should be submitted by the physician to the concerned Ethics Committee and notified in parallel to AIFA. Specific eligibility criteria need to be met. Such requests are evaluated during routine EC meetings unless urgency is highlighted. In this context the drug must be provided free of charge by the company.

The applicability of the available options has to be evaluated on a case-by-case basis.

The European Commission has officially completed the EU Health Technology Assessment (HTA) framework by publishing the final implementing act that defines how Joint Clinical Assessments (JCAs) will be conducted for medical devices and in vitro diagnostics (IVDs) under Regulation (EU) 2021/2282.

Published on 17 October 2025, this is the sixth and last implementing act required for the full application of the HTA Regulation, which became effective on 12 January 2025. The implementing act enters into force on 9 November 2025, marking a major milestone in building a unified, transparent European HTA system.

Key Points

• Establishes procedures for cooperation between Member States, the European Commission, notified bodies, and expert panels.
• Defines how developers, patients, and clinical experts are engaged throughout the assessment.
• Introduces standard formats and templates for dossier submissions and joint assessment reports.
• Clarifies processes for stakeholder consultation and evidence presentation, ensuring consistency across Member States.

Why It Matters

This regulation provides clarity and predictability for medical device and diagnostic manufacturers entering the EU market.
For regulatory, legal, and market access teams, it is time to:

• Align evidence-generation strategies with JCA requirements;
• Prepare dossiers following the new templates;
• Plan early stakeholder engagement with clinical and patient organisations.

The completion of the HTA framework represents a shift toward harmonised, patient-centred assessments that will streamline access to innovative technologies across Europe.

RPN remains committed to monitoring regulatory developments and providing timely insights to help stakeholders navigate the evolving landscape of health technology assessments in Europe.
Through continuous engagement and expertise in regulatory affairs and market access, RPN supports companies in aligning their strategies with the latest EU requirements to ensure successful and compliant market entry.