By Ioanna Michalopoulou, LLM, Managing Partner
By Dimitrios-Aineias Spiliotis LLB, Senior Associate
Law 5302/2026 establishes the Innovation Fund, a standalone framework for access to ATMPs and PRIME medicines, reshaping inclusion, pricing, MAH liability and physician sanctions
Law 5302/2026 (ν. 5302/2026), entitled “Establishment of the Innovation Fund – Patient Access to New Medicines and Therapies – Improvement of Health Services and Other Provisions”, was published in Government Gazette A’ 78 (ΦΕΚ Α’ 78) of 20 May 2026. The Greek legislation acquires for the first time an autonomous regulatory framework for financial access to advanced therapy medicinal products (ATMPs) and to medicines of the PRIME priority program of the European Medicines Agency.
The Fund covers exclusively advanced therapy medicinal products within the meaning of Regulation EC 1394/2007 and PRIME medicines of the EMA. Beneficiaries are exclusively holders of a Social Security Registration Number (ΑΜΚΑ) residing in Greece, while the financing originates from a special annual appropriation of the State Budget. The transfer of resources to other pharmaceutical or healthcare needs is expressly prohibited by Article 3, excluding their use as a safety valve for covering deficits of other pharmaceutical expenditures.
Article 4 introduces four cumulative inclusion conditions: (a) prior inclusion of the medicinal product in the annual Horizon Scanning report, submitted by the Marketing Authorization Holder to the Directorate of Medicines of EOPYY (ΕΟΠΥΥ) pursuant to Article 10 of Law 4931/2022 (ν. 4931/2022) and notified each January to the Innovation Fund Committee, (b) a request from a scientific society recognized by the Central Health Council (ΚΕΣΥ) addressed to the Committee on the necessity of administration, (c) an undertaking by the MAH, through a solemn declaration for continued administration until completion of the therapy under paragraph 11 of Article 6, (d) an agreement with the Committee on the data to be collected and on the duration of remaining within the Fund.
Failure to enroll in Horizon Scanning excludes access from the outset, since the criterion is procedural and not therapeutic. MAHs holding an ATMP pipeline or PRIME asset for the years 2026 or 2027 must initiate preparations within the current annual declaration cycle.
For ATMPs requiring a certified administration center, Article 6 paragraph 5 requires a demonstrated capacity to commence operations in at least one Greek center, with the relevant MAH-center contract co-submitted prior to the application. Where certification is in progress, the supporting evidence is submitted by the start of administration. Additional centers are declared during the procedure, without affecting the estimated number of eligible patients. In practical terms, MAHs must hold in advance standardized contractual templates with Greek clinical centers, covering pharmacovigilance, staff training and documentation of quality procedures.
The Law introduces for the first time a comprehensive legislative foundation for agreements based on therapeutic outcome, on indication and on milestones, at two levels. First, the Innovation Fund Committee, under Article 6 paragraph 6, negotiates discounts on the basis of estimated value and establishes additional discounts through outcome-based agreements or therapeutic milestones.
Second, Article 17 amends Article 254 of Law 4512/2018 (ν. 4512/2018) on the Medicinal Product Price Negotiation Committee. In paragraph 6, by derogation from the general criteria, the conclusion of agreements not based on clawback/rebate is permitted, for joint clinical assessments and Fund products. In paragraph 9, a full menu of permissible agreements is laid down: discounts, volume-based tiered discounts, outcome-based agreements, per indication, risk-sharing and linkage to therapeutic milestones. This is a critical development for high-cost gene therapies and cell therapies, as the Law provides the legal basis for annuity payments and risk sharing, which were difficult to ground within the horizontal clawback/rebate mechanisms. In addition, during its stay in the Fund, the product is exempt from automatic clawback returns, the only exceptions being the discounts of Article 6 paragraph 6 and the returns of Article 35 of Law 3918/2011 (ν. 3918/2011).
Following exit from the Fund, the Negotiation Committee invites the MAH to negotiate the reimbursement terms. In the event of failure before the Committee, the product is not included in the positive list of Article 12 of Law 3816/2010 (ν. 3816/2010). The new arrangement intervenes drastically in this scenario, since, where the treating physician considers continuation of therapy necessary, the MAH is obliged to provide the product free of charge in cases of therapy of up to three months or chronic therapies without a demonstrated significant additional clinical benefit. Conversely, where benefit is demonstrated, administration continues under the financial terms of the stay within the Fund. Non-compliance with the obligation entails administrative and criminal sanctions.
Beyond the liability of the MAH, Article 6 paragraph 10 introduces autonomous sanctions on the treating physician. Failure to complete outcomes in the National Patient Registry within the prescribed intervals entails the fine of point (b) of paragraph 4 of Presidential Decree 121/2008 and a prohibition of access to the Electronic Prescription System for a new Fund patient, where compliance does not occur within one month.
Practical implementation depends on the regulatory acts of Article 89, since the following are pending: the Ministerial Decision on the operation of the Committee, the Ministerial Decision on the inclusion of each therapy and on the approval of indicators, the Joint Ministerial Decision on the procedure of administrative fines and the Ministerial Decision of establishment. Until their issuance, the new architecture remains partially suspended as to its functional activation. In overall terms, Law 5302/2026 alters simultaneously the rules of access, pricing, liability, compliance and personal exposure of physicians, shaping a new reality for advanced therapies in Greece.
