In this issue we cover the following topics:
- Dispensing of Hospital Medicines in Proximity
- Probative Force of the Medical Certificate of Multipurpose Incapacity
- New Rules for Medical Devices
- Reinforced Autonomy for SNS Clinical Research Centres
- The Use of Artificial Intelligence in the Health Sector in Portugal
Dispensing of Hospital Medicines in Proximity
The dispensing of hospital medicines in proximity provides easier access to medicines for patients, without compromising safety and close monitoring by health professionals.
In the first quarter of 2024, the Portuguese government finalised the regulation of the dispensation of medicines and health products prescribed for hospital outpatients, within the scope of National Health Service (SNS) establishments and services. This regime, established by Decree-Law No. 138/2023, of December 29th, and consolidated by Ordinances No. 104/2024/1 and No. 106/2024/1, of March 14th, has revolutionised the distribution of hospital medicines throughout Portugal by providing easier access to medicines for patients, without compromising safety and close monitoring by health professionals.
All patients who are prescribed hospital dispensed medication are potential beneficiaries of this scheme, as long as there is an appropriate assessment by the medical teams and the patient’s consent. With the new legislation and regulations, these patients will be able to receive their medication in more accessible places, such as community pharmacies, eliminating the need for frequent trips to hospitals. This dispensing is particularly relevant for people with reduced mobility or who live in areas far from large urban centres, as well as providing a significant reduction in costs and time, avoiding absences from work and travel expenses.
In force since May 15th, 2024, the regulation on the dispensing of hospital medicines in proximity represents a significant advance in the humanisation of healthcare, putting the patient at the centre of decisions by facilitating access to essential medicines.
Probative Force of the Medical Certificate of Multipurpose Incapacity
The medical certificate of multipurpose incapacity is an authentic document that provides full proof of the facts practised and perceived by the competent ‘medical board’ and evidence subject to the free assessment of the judge as to the facts corresponding to the medical assessment answers and the determination of the percentage of incapacity of the person assessed.
The Portuguese Supreme Court of Justice Ruling No. 8/2024, of June 25th, standardised case law to the effect that the medical certificate of multipurpose incapacity, issued to people with disabilities in accordance with Decree-Law No. 202/96, of October 21st, is an authentic document which, in accordance with Article 371(1), in conjunction with Article 389 of the Portuguese Civil Code, is full proof of the facts carried out and perceived by the competent ‘medical board’ (public authority) and evidence subject to the free judgement of the judge as to the facts corresponding to the medical assessment answers and the determination of the percentage of incapacity of the person assessed.
The present appeal to standardise case law sought to clarify the legal nature and probative force of the ‘medical certificate of multipurpose incapacity’ issued by a Regional Health Administration (a public institute within the Ministry of Health). The question centred on whether the ‘medical certificate of multipurpose incapacity’ constitutes evidence based on an authentic document, with full probative force for all of its content, as upheld in the founding judgment, the Supreme Court of Justice judgment, handed down on November 24th, 2016; or whether, conversely, the ‘medical certificate of multipurpose incapacity’ constitutes evidence of an expert nature, subject to the free assessment of the court, as upheld in the judgment under appeal.
New Rules for Medical Devices
Decree-Law No. 29/2024’s primary purpose is to guarantee the safety, efficacy and quality of medical devices and their accessories.
Decree-Law No. 29/2024 was published on April 5th, 2024, ensuring the implementation in the Portuguese legal order of Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5th. 2017, on medical devices, commonly referred to as the Medical Devices Regulation (MDR). The entry into force of the MDR has led to a reformulation of the Portuguese legal regime regarding medical devices and their accessories, harmonising it with the provisions enshrined at European Union level and, concretely, with the MDR.
Decree-Law No. 29/2024’s primary purpose is to guarantee the safety, efficacy and quality of medical devices and their accessories. To fulfil this purpose, it establishes a set of rules applicable to economic operators and health institutions that manufacture and use devices on their premises, as well as rules on the use and traceability of devices, the designation and supervision of the activity of notified bodies and market surveillance and inspection.
In addition to regulating the manufacture, distribution and use of medical devices and their accessories, Decree-Law No. 29/2024 establishes the rules applicable to devices manufactured and used in healthcare institutions, introducing specific traceability rules that allow these devices to be effectively monitored throughout their life cycle.
In conclusion, the enactment of Decree-Law No. 29/2024, together with the MDR, represents a significant advance in the regulation of medical devices in Portugal. By ensuring strict safety, efficacy and quality standards at all stages of the device life cycle, from design to end use, this regulation aims to increase patient safety and promote innovation in the medical device sector.
Reinforced Autonomy for SNS Clinical Research Centres
The reinforcement of the capacity and autonomy of the Clinical Research Centres emerges in a context in which clinical research in Portugal, despite having considerable potential, falls short of the capacities of the national health and scientific system.
On February 14th, 2024, Order No. 1739/2024 was published, determining a set of measures that provide Clinical Research Centres (CICs) operating within the National Health Service (SNS) with greater capacity and autonomy. These measures stem from the recognition of clinical research and biomedical innovation (CI&IB) as fundamental pillars for a country’s socio-economic development, with a direct impact on improving healthcare and creating jobs and economic value.
The reinforcement of the CICs’ capacity and autonomy comes in a context where clinical research in Portugal, despite having considerable potential, falls short of the capacities of the national health and scientific system. With more than 30 billion euros invested annually in Research and Development (R&D) in Europe, Portugal has the opportunity to capture a greater share of this investment, increasing the number of clinical trials carried out in Portugal and, consequently, generating more economic and social value.
NHS health units are encouraged to adopt organisational models that offer greater management autonomy, such as setting up CICs as Integrated Responsibility Centres (IRCs) or as non-profit private law associations. These structures will allow for more efficient and flexible management, facilitating collaboration with other organisations and attracting resources. The transformation of CICs into IRBs or their integration into existing IRBs aims to improve the efficiency and response capacity of the centres, which is crucial for the development of IC&IB activities. In addition, the possibility of creating non-profit private law associations will expand collaboration and funding networks.
The Ministry of Health will be responsible for issuing the necessary guidelines for the implementation of these measures and, simultaneously, ensuring that the NHS CICs are properly prepared to adopt the new organisational forms. In this way, Portugal has the opportunity to assert itself as a leader in clinical research and health innovation.
The Use of Artificial Intelligence in the Health Sector in Portugal
The introduction of Artificial Intelligence (AI) in the health sector in Portugal is proving to be a promising opportunity to modernise and optimise patient care.
The introduction of Artificial Intelligence (AI) in the health sector in Portugal is proving to be a promising opportunity to modernise and optimise patient care, as well as an innovative response to contemporary challenges such as the overload of health professionals and the growing demand for faster and more accurate diagnoses.
A significant example of this technological transformation is the line of funding launched by the National Health Service (SNS) for the implementation of AI tools in dermatological diagnoses. With this initiative, patients will be able to use an application that, by photographing their skin condition and analysing it through AI algorithms capable of identifying dermatological pathologies, allows suspicious cases to be prioritised and rapidly referred to a dermatologist. This approach accelerates the diagnostic process and its accuracy, ensuring that patients receive the appropriate treatment in a timely manner.
According to Fernando Araújo, Executive Director of the SNS, this initiative underlines the SNS’s commitment to using innovative technologies to improve access, efficiency and the quality of healthcare in Portugal. Tomás Costa, Dermatologist at the SNS, emphasises that this project represents a significant step towards modernising the SNS, with a special focus on the dermatological lesions with the highest risk and prevalence, such as skin cancer. In this way, the integration of AI into clinical practice will not only make it possible to make the most of dermatologists’ time, but also to qualify the response to the most critical cases, reinforcing the vision of the SNS as an innovative and technologically advanced health system.