The Greek Parliament voted on 15 May 2026 by the Greek Parliament the new legislative framework for patient access to new innovative treatments entitled “Establishment of a Drug Innovation Fund – Patient access to new medicines and treatments – Improvement of health services and other provisions”.
The law was officially published on 20 May 2026 in the Government Gazette here: OFFICIAL GAZETTE NO. 78/20-05-2026.
Ο Panhellenic Cystic Fibrosis Association “Unlimited Breath” and the Panhellenic Lung Fibrosis Association “Lungs of Life” welcome the important improvements incorporated in the new legislative framework for access to new innovative treatments for patients with rare and serious diseases. These improvements are considered particularly crucial for patients with rare and serious diseases, as they enhance the possibility of timely and safe access to new life-saving innovative treatments.
These treatments include modern and specialised, high-cost treatmentssuch as precision treatments, gene therapies and newer targeted therapies for Rare Diseases, which can substantially alter the course of serious and life-threatening diseases.
The two Associations, representing thousands of patients and families from all over Greece, closely followed the process of formulating and passing the bill and actively participated in the public debate, submitting specific proposals for legislative and technical improvements on access to innovative treatments and early access mechanisms for patients with rare diseases through the SSI and the EFET.
In this context, the following took place successive interventions and the sending of joint letters to the Ministry of Health, the Prime Minister’s Office, all political leaders and parliamentary partieseven during the the final stage of drafting the bill, with the aim of ensuring timely and safe access for patients to new life-saving innovative treatments that we expect to come to Greece in the coming years.
A particularly important development is the incorporation in the final text of Article 12 of the law of provisions that move in the direction of the Associations’ proposals and enhance the access of patients with rare and life-threatening diseases to newer innovative treatments.
These include institutional recognition of mechanisms for early access to innovative treatments, such as:
– early access programmes
– compassionate use programmes (compassionate use)
– temporary licences
– individual patient requests
– cases of off-label/non reimbursed indications
This addition is considered particularly important as it recognises institutionally the importance of early access mechanisms to innovative therapies before the completion of the reimbursement procedures for medicinal products in the Member States of the European Union, which often take a considerable amount of time.
Important improvements are also the strengthening of the exceptions for rare and extremely rare diseases, the possibility of taking into account strong scientific evidence and documented medical need, and the provision for un-reimbursed or unapproved indications in cases of serious and life-threatening conditions.
Another positive development is the the removal of additional administrative procedures that could lead to delays in access, as well as the strengthening of the institutional participation of patients through the presence of patient representatives as observers in relevant evaluation processes.
For patients with rare and serious diseases, access to new innovative therapies is not just a matter of pharmaceutical policy, but a matter of preserving life, increasing survival, maintaining functionality and improving the quality of life of patients.
The President of the Panhellenic Cystic Fibrosis Association, Anna Spinou, said:
“For patients with Cystic Fibrosis, innovative treatments have changed the course of a deadly disease that starts at birth and that until a few decades ago prevented many patients from reaching adulthood.
Today, thanks to science and early access to innovative treatments, children with Cystic Fibrosis can grow up, dream, study, work and live with greater functionality and a better quality of life.
Ensuring access to the newer high-cost specialist therapies, such as newer generation CFTR modulators, mRNA therapies, gene therapies and personalised therapies that we expect to come in the coming years, is vital.
This is particularly important for patients who currently are ineligible for innovative treatment options or are already experiencing significant disease burden, as well as for transplant recipients, for whom emerging therapeutic approaches may offer future opportunities when considered medically appropriate.
The President of the Panhellenic Lung Fibrosis Association “Lungs of Life”, Maria Thanou, said:
“For patients with Pulmonary Fibrosis, any delay in access to treatment can mean loss of precious time, loss of breathing and deterioration of daily life.
Pulmonary fibrosis is a disease that can occur suddenly and radically change the life of a person and their family.
This is why early access to available and future innovative treatments is crucial. The institutional recognition of early access mechanisms is an important step for the rare disease patient community.”
The The two Associations warmly thank the Ministry of Health, the Prime Minister’s Office, the political leaders and the parliamentary parties for their attention and contribution to the public debate on patient access to the newest innovative treatments.
At the same time, they commit themselves to continue to closely monitor the implementation and further development of the new frameworkin practice, with a view to ensuring equitable, timely and safe access for all patients to the necessary treatments and health services.
The Associations also underline the importance of ongoing cooperation with the medical and scientific community, specialised monitoring centres and all stakeholders, to ensure timely, safe and equitable access of patients to the necessary treatments.
Because early access to innovation means life, hope and Breathless Breath for all!
The initial interventions of the Associations during the initial public consultation stage of the draft law are available here: cysticfibrosis.gr/2026/05/06/107659
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Cystic fibrosis is a rare genetic disease that occurs from birth and mainly affects the lungs and pancreas. Despite significant progress in recent years, it remains a serious, chronic and life-threatening disease. Pulmonary fibrosis occurs mainly in adulthood and can lead to severe and progressive respiratory failure. Although they are different diseases, both can lead to end-stage respiratory failure, where lung transplantation may be the only option for survival.
More about Cystic Fibrosis and Pulmonary Fibrosis on the websites of the Associations:
🌐 cysticfibrosis.gr
🌐 ipfgreece.gr
