This best practice example discusses Romania’s groundbreaking law, the first in the world to recognise the right of citizens and patients to personalised medicine. Initiated following the EU Council’s 2015 personalised medicine policy, the law is the result of a multi-sectoral collaboration led by the Centre for Innovation in Medicine in Romania, using a quadruple helix model (later developed into a penta helix) involving the academia, public, private and civil society sectors. The law, promulgated on 24 May 2023, gives patients a legal right to personalised health care in a manner that takes into account individual genetic and phenotypic characteristics.
© Center for Innovation in Medicine, Marius Geanta
The law complements the patient rights law and recognises that ‘‘personalised medicine refers to healthcare provided based on a medical model that utilises the characterisation of individuals’ phenotypes and genotypes. This involves offering preventive, diagnostic, curative, rehabilitative, and specific end-of-life care services tailored to each patient’’ (Romanian Parliament, 2023).
Romania’s landmark law is the first globally, acknowledging the right of citizens and patients to personalised medicine.
The law established the following: The patient has the right to personalised medicine based on medical recommendation. To ensure the right to personalised medicine, the specialist doctor is obliged to provide the patient with reliable, pertinent, and easily understandable information regarding options for proposed medical interventions, including anticipated benefits and risks. Patient consent is mandatory for each specific medical intervention in personalised medicine. The collection, sharing, management, and standardisation of data necessary for the development and application of personalised medicine are carried out in accordance with the data protection legislation (General Data Protection Regulation). This pioneering legislation paves the way for integrating personalised medicine into Romania’s health care system, shaping clinical practice, research, and health policy. In all, it marks a significant step in redefining health care delivery, emphasising individualised treatment and the political determinants of personalised medicine, and setting a precedent for future health care innovations worldwide.
Reflection on Adopting the Romanian Personalised Medicine Law as a Best Practice for National Implementation
The Romanian law on the right to personalised medicine, promulgated in May 2023, offers a robust example of how personalised medicine (PM) can be successfully implemented within a national healthcare system. This legislation not only incorporates global best practices but also addresses the specific healthcare needs of Romania, making it a model for other countries seeking to adopt similar approaches. Below, we outline key elements of the Romanian experience and how these can serve as best practices for the implementation of personalised medicine in any country.
Legislative Framework as a Foundation for Implementation
The Law as a Right: Romania’s personalised medicine law enshrines personalised medicine as a legal right for its citizens, moving beyond the theoretical and into enforceable healthcare practices. By doing so, it guarantees patients’ access to personalised medicine based on their individual characteristics (genetic, phenotypic, lifestyle) and sets a legal obligation for healthcare providers to deliver this tailored approach.
Clear Definitions and Responsibilities: The law clearly defines personalised medicine, detailing the role of healthcare providers in informing patients and obtaining consent for each specific intervention. It is crucial for reducing ambiguity and ensuring uniform application across different healthcare institutions.
Data Management and Privacy
Alignment with GDPR: One of the notable strengths of the Romanian law is its commitment to data management, ensuring that patient data is collected, shared, and standardised in accordance with the EU’s General Data Protection Regulation (GDPR). This integration demonstrates a proactive approach to managing patient data in personalised medicine while addressing privacy concerns, which is essential in fostering public trust.
Data as a Backbone for Genomic Medicine: The law not only promotes the collection of patient data but also aligns with major EU initiatives like the 1+ Million Genomes Declaration. This allows Romania to be part of a larger European network, offering valuable data for research and healthcare while benefiting from shared genomic resources.
Multisectoral Engagement and Governance: The Penta Helix Model
Expanding the Quadruple Helix (academia, public, private, civil society to Penta Helix, including political determinants of health: It recognises the essential role of political stability, legal frameworks, and policy in successfully implementing personalised medicine.
Engagement of Key Political Stakeholders: Through active engagement with the Presidency, Parliament, and Ministry of Health, Romania was able to anchor personalised medicine within national health strategies, including cancer control plans. Other nations can emulate this approach by fostering strong collaborations between policymakers and scientific communities.
National and International Collaboration
Leveraging EU and Global Initiatives: Romania’s integration into European initiatives such as the Beyond 1 Million Genomes project, and its subsequent signing of the 1+ Million Genomes Declaration after the law’s implementation, shows the importance of international collaboration in advancing personalised medicine. The Romanian model demonstrates how countries can leverage international partnerships to accelerate their own personalised medicine strategies, gaining access to larger pools of genomic data and research.
Cross-Sectoral Involvement: Romania’s implementation of personalised medicine also involves private sector stakeholders, including the pharmaceutical industry, biotech companies, and digital health providers. It encompasses not only healthcare delivery but also innovation and business opportunities.
Challenges and Solutions in Implementation
Addressing Siloed Thinking: By creating an organisational structure (such as the Centre for Innovation in Medicine) dedicated to bridging gaps between sectors, Romania has laid the groundwork for a more holistic approach to healthcare. This can serve as a model for other countries where interdisciplinary collaboration is essential for personalised medicine implementation.
Ensuring Political Commitment: Countries adopting personalised medicine strategies should ensure there are dedicated bodies that can persist through political changes to ensure continuity.
Key Areas for Future Consideration
Integration of Genomic and Digital Health Innovations: As personalised medicine continues to evolve, the law sets a precedent for integrating genomic medicine and digital health into the national healthcare framework. Future regulations will likely focus on introducing genomic tests for cancers and rare diseases, an approach that other countries could adopt to expand their own personalised medicine efforts.
Redefining the Doctor-Patient Relationship, ensuring that patient consent is a critical part of the personalised medicine process: This focus on ethics, safety, and transparency is essential for maintaining patient autonomy and trust in new medical models.
Conclusion
The Romanian law on personalised medicine is a pioneering step that offers valuable lessons for the implementation of personalised medicine globally. By providing a strong legal framework, ensuring multisectoral engagement, aligning with international genomic data initiatives, and addressing challenges such as political turnover and siloed thinking, Romania has created a scalable model. Countries aiming to implement personalised medicine can adopt similar strategies to ensure the successful integration of personalised healthcare into their systems.