Katarina Raud

LLM Health and Technology Law, and LLM Energy and Climate Law

University of Groningen

k.raud@student.rug.nl

 'Knowledge is power. Information is liberating. Education is the premise of progress, in every society, in every family.'

- Kofi Annan[i]

 It's for a reason that Estonia is also called an E-state, from online voting to online notary, the innovation also extends to health-care and especially to prescriptions. Estonia has been proactive in developing policies to ensure consumers' right to information in healthcare, home and abroad. Access to information is key to empowering people to make informed decisions about their health. How is this area regulated? Are digital prescriptions making a difference in the context of the right to information? I'm going to delve into those questions.

Legal frameworks

Estonians have shown word-class innovation when it comes to e-prescriptions with the aim to provide patients the most detailed information regarding their prescribed medications, including dosages and possible side-effects. The aim is to ensure a smooth process starting from prescribing the medication, to a person going to pharmacy and later having the opportunity to always go back to the instructions as long as they authenticate themselves using their ID. Key regulatory frameworks include Health Services Organisation Act (HSOA)[ii] and Medicinal Products Act (MPA).[iii] In addition to national frameworks, European Charter of Patients’ Rights (ECPR)[iv] is widely relied on in Estonia.

HSOA's, which regulates the healthcare services, including the rights and obligations of healthcare providers and patients, chapter five-one focuses on the healthcare information system. Said chapter covers everything from definitions to data transfers, enabling access to health information system data and ethics. The act plays a critical role in safeguarding the rights of patients online and offline. It ensures that consumers have access to accurate and relevant information to make informed decisions regarding their healthcare options.

Moving onto the MPA, amongst governing the distribution and use of medicinal products, MPA also plays a crucial role in safeguarding the public and ensuring that the consumers are informed on every step of the way. For example, article 33(1)(1) of MPA establishes that selling prescription medicine based on an electronic prescription is permitted, however it's important not to forget that article 33(5) of MPA places an obligation on the seller to inform the individual about the correct and safe use, and storage of the medicine, even if the information is available online. Of further interest is that an individual who is authorised to prescribe medicine is obligated to do so in electronic form, unless there is a good objective reason that doesn't allow them to do so.[v] This gives the consumer an extra layer of protection since that allows them to always go back to the health-portal and look up their individual instructions. 

When turning attention to international law, in the context of this blog the most noteworthy instrument is ECPR. It isn't a binding instrument, but nevertheless influential. Estonian Patients Union official website confirms this by stating: “The purpose of the patient's rights is to ensure "a high level of protection of human health" (Article 35 of the EU Charter of Fundamental Rights) and to ensure the high quality of services provided by the state's healthcare system. These rights must be protected everywhere in the EU, including Estonia.”[vi]

Article 3 of ECPR empowers individuals with a right to information by ensuring individuals access to their health status, services and advancements in medical science. Healthcare providers must tailor information to patients' needs, remove barriers, and provide access to medical records. Based on the same article, they also have the right to access accurate, reliable, and transparent information on scientific research and innovations, which is also further explained in article 10 of ECPR. Upholding this right once again empowers patients to make informed decisions, fostering trust and transparency in healthcare.

Are digital prescriptions making a difference?

The national health record system, which is also known as “Terviseportaal” gives individuals access to their personal health-data such as medical records, prescriptions and diagnostic results.[vii] The system is kept secure by only letting authorised individuals access the data after identifying themselves using the electronic ID-card.[viii] 

The main goal of taking prescriptions to the digital world is to improve medical care. Since the healthcare provider will have access to all the patient's prescriptions,[ix] they will be better informed than before when making treatment decisions and have the opportunity to inform the patient better about the treatment. The pharmacist's work is more convenient, as the amount of data entered into the computer manually decreases. The most obvious benefit of digital prescriptions is the fact that individuals no longer have to carry prescriptions with them and can be sure that all relevant information is in the system already and they always have a way to access information regarding their prescriptions.

Estonia has enabled the transmission of both digital prescriptions and a summary of the patient's health-data to other countries that have joined the cross-border digital prescription service. If an Estonian patient needs to receive medical care abroad and that country has joined the service, the foreign doctor has the opportunity to receive a summary of the medical history translated into the language of their country from the information system.[x] This shows how the right to information can be extended from an individual to a doctor and how it can save the individual's life. 25 European countries have joined the cross-border data exchange project, but not all of the states have fully implemented it yet as they are opening their digital prescription and health-data summary services according to national possibilities.[xi] 

Takeaways from Estonia

Today where almost everything is digitised it's clear that the role of consumer protection becomes even more topical, the human component is taken out of many services which oftentimes is the aspect which helps consumers understand their possibilities given that it's easier to ask for information and do due diligence. The same doesn't always apply in the digital world. Due to the concept of digital prescriptions being modern, there is still a lack of case law from where legislators could learn the weaknesses and possible loopholes of the existing legislation, therefore we just have to be patient and wait for legal conflicts to occur in the future. 

As shown above, innovative e-solutions have revolutionised Estonia’s healthcare system home and abroad. While such digital advancements are impressive by themselves, it's praiseworthy that Estonia has managed to do it with one thing in mind - the people and their autonomy. People have been given tools that allow them to really exercise their right to information in the context of healthcare, and that is something that every country should strive for, innovation and welfare information society, where citizens are encouraged to stay informed and access information 24/7.

[i] United Nations ''If information and knowledge are central to democracy, they are conditions for development' says secretary-general' (Press release SG/SM/6268, 23 June 1997) https://press.un.org/en/1997/19970623.sgsm6268.html accessed 02.05.2024 

[ii] Tervishoiuteenuste korraldamise seadus [2001] RT I 2001, 50, 284 (Eesti keeles) https://www.riigiteataja.ee/akt/110032011009 accessed 27.04.2024

[iii] Ravimiseadus [2004] RT I 2005, 2, 4 (Eesti keeles) https://www.riigiteataja.ee/akt/104012019011 accessed 27.04.2024

[iv] European Charter of Patients' Rights Basis Document [2002] Rome. https://ec.europa.eu/health/ph_overview/co_operation/mobility/docs/health_services_co108_en.pdf accessed 28.04.2024

[v] Ravimiseadus [2004] RT I 2005, 2, 4 (Eesti keeles), Article 81(7) https://www.riigiteataja.ee/akt/104012019011 accessed 27.04.2024

[vi] Eesti Patsientide Liit ‘Euroopa Liidu Põhiõiguste Hartast tulenevad patsiendi õigused (2002) II osa’ (Patsiendid.ee) https://www.patsiendid.ee/patsiendi-oigused/euroopa-patsiendioiguste-harta accessed 26.04.2024

[vii] Terviseportaal https://www.terviseportaal.ee/portaali-teenused/ accessed 09.05.2024

[viii] e-Estonia 'Overview of Estonian e-Health ecosystem' (e-estonia.com) https://e-estonia.com/programme/digital-healthcare/ accessed 08.05.2024

[ix] Tervisekassa 'Digiretsept'  https://www.tervisekassa.ee/inimesele/ravimid/digiretsept accessed 09.05.2024

[x] Jaagus T, 'Lugu sellest, kuidas digiretseptid ja terviseandmed patsientidega Euroopas kaasas käivad ' Eesti Rohuteadlane (04.2022) https://www.tehik.ee/sites/default/files/2022-11/RT_2022_4_lk12-15.pdf accessed 01.05.2024

[xi] Tervise ja Heaolu Infosüsteemide Keskus 'Eestlaste ja lätlaste digiretseptid liiguvad nüüd piiriüleselt ' (tehik.ee, 13.03.2024) https://www.tehik.ee/uudis/eestlaste-ja-latlaste-digiretseptid-liiguvad-nuud-piiriuleselt accessed 05.05.2024