The legal landscape for the provision of home respiratory care in Portugal

Ricardo Costa Macedo
Ferreira Pinto Cardigos, Lisbon
rcm@fpclegal.pt

Oxygen is a very useful gas! Once stored in gas cylinders, following the development of compressed gas technology and pressure regulation at the end of the 19th century, its use for medical purposes became possible.

Considered an essential medicine by the World Health Organization, oxygen has multiple uses and is essential in the treatment and maintenance of healthcare for millions of people worldwide, both being treated in hospitals and at home.

In fact, oxygen is crucial in the treatment of patients with various respiratory, cardiovascular and other conditions.

Understanding the current legal framework for the provision of home respiratory care services in Portugal involving the use of oxygen requires an understanding of some of the legislative, regulatory and contractual advances that have taken place in this area in the 21st century.

Oxygen as a medicine

Firstly, it is important to consider the Statute of Medicines. Established by Decree-Law 176/2006, which transposed Directive 2001/83/EC of the European Parliament and of the Council of the European Union, the Statute of Medicines included, for the first time, a definition of medicinal gases.

It was established in Article 149(1) that all medicinal gases that meet the definition of a medicine and are prepared industrially or involve an industrial process during their manufacture are covered by the provisions set out in the Statute of Medicines, as well as by the legislation concerning Good Manufacturing Practices for Medicines.

In this context, medicinal gases, such as medicinal oxygen, became subject to the obligation to submit a marketing authorisation application, granted by Portugal’s National Authority of Medicines and Health Products (Autoridade Nacional do Medicamento e Produtos de Saúde, otherwise known as INFARMED), just like with other medicines.

It was also established that when dealing with medicinal gases the technical quality requirements set out in the Portuguese Pharmacopoeia (or, in its absence, the European Pharmacopoeia or that of another EU Member State) must be met. Subsequently, it was decided that the regulation for this category of medicines should be defined by INFARMED.

In 2008, the INFAMED Medicinal Gases Regulation provided for in Article 149(4) of the Statute of Medicines was approved. This Regulation governs the manufacture, primary and secondary packaging, labelling, the details concerning the information leaflet, technical direction, transportation, distribution, marketing, supply and home delivery of medicinal gases.

Accordingly, the distribution and delivery of medicinal gases to a patient’s home depends on the granting of authorisation from INFARMED and compliance with the Good Practices for Distribution and Home Delivery of Medicinal Gases provided in the Annex to the aforementioned Regulation.

Authorisation to carry out the distribution and home delivery of medicinal gases is subject to certain conditions and requirements, such as the requirement to have a permanent pharmacist within the firm who ensures the adequacy of the technical direction, the requirement to have suitable facilities and equipment and the requirement to demonstrate adequate transportation conditions.

Indeed, among the obligations imposed on holders of the authorisation for the distribution and home delivery of medicinal gases is the requirement to retain an adequate technical direction and personnel with appropriate qualifications and training, the requirement to have a quality assurance system in place,  the requirement to ensure that the patient and those around them are properly informed about the relevant risks and information, requirements concerning the technical maintenance of the equipment, the requirement to have a permanent telephone service in operation, requirements related to the development and implementation of a distribution and delivery procedure that avoids supply disruptions and requirements related to the repair or replacement of defective equipment.

This Regulation also stipulates that medicinal gas must be dispensed to the patient according to the doctor’s medical prescription for that patient.^[1]

In 2011, the Directorate-General for Health published the clinical guidance for home respiratory care in Portugal (Directorate-General for Health norm numbers 021/2011; 018/2011; 022/2011), which would later be reviewed and updated.

The innovative model for contracting home respiratory care

Considered a fundamental milestone in the contracting of respiratory care in Portugal, in 2013, the Shared Services of the Ministry of Health in Portugal (Serviços Partilhados do Ministério da Saúde, E.P.E. or SPMS) launched a public tender on the conclusion of public procurement contracts for the provision of home respiratory care services (CP 2013/100).

This innovative model established, for the first time, geographical equity and universality in terms of access by users of the National Health Service to all home respiratory care therapies offered by various providers.

Previously, the contracting of home respiratory care services was highly variable and asymmetric at the national level.

Noteworthy in the evolution of the provision of respiratory care in Portugal is the introduction of mandatory electronic prescriptions for home respiratory care services through a computer application provided by the SPMS, from 30 November 2013, through Order No. 9309/2013 of 9 July (subsequently replaced) and Order No. 15967/2013 of 3 December.

However, the implementation of electronic prescriptions for home respiratory care services took place later, in 2016.

The CP 2013/100 agreement for the provision of home respiratory care services was renewed by the CP 2017/100 agreement.

In 2019, Order No. 7275/2019 of 9 August was published, approving, within the scope of the National Health Service, the General Regulation for the prescription and billing of home respiratory care services.

This order defined the procedures necessary for the prescription of home respiratory care services for the benefit of users of the National Health Service and governed the procedures for billing and payment to suppliers of home respiratory care services provided pursuant to the relevant public procurement contracts.

The Framework Agreement 131/2022

On 19 December 2022, the Framework Agreement 131/2022 was published.

Established by the SPMS, it concerns the provision of home respiratory care services, with the aim of selecting qualified providers to supply respiratory health services to patients in their homes. This Framework Agreement came into force on 1 October 2024 and currently regulates the provision of home respiratory care services in Portugal. It follows the principles laid down in CP 2013/100.

Under this Framework Agreement, and as previously, home respiratory care services are understood as the outpatient provision of services and the supply of the necessary equipment to the patient at their residence, with the aim of restoring and maintaining their maximum level of comfort, function and health, covering the following treatment modalities: aerosol therapy, oxygen therapy, ventilation therapy and other treatments.

The financial responsibility for the payment of costs arising from the provision of home respiratory care services lies with the prescribing entity, observing the principle of the prescriber payer.

Moreover, at the time when the prescription is issued, the prescribing doctor must allow the patient to choose a supplier from among the list of suppliers covered by the relevant public procurement contracts for the prescription of home respiratory care services and the doctor cannot make this choice on behalf of the patient. The prescribing doctor is responsible for providing the relevant information about the different options in regard to the provision of home respiratory care services at the time of issuance of the prescription and its renewal, as well as being responsible for providing the treatment guide to the patient, preferably in electronic format.

The main changes brought in by this new Framework Agreement relate to aspects such as prescription renewals. Currently, patients are responsible for requesting prescription renewals every six months.^[2] Without a valid prescription, the government does not cover the relevant treatment costs.

On the other hand, treatment adherence gains increased relevance in this context: patients must strictly follow the medical instructions, such as concerning the use of therapy equipment for a minimum number of hours daily. A lack of adherence to the treatment may result in the removal of the equipment or the patient being made financially responsibility for the treatment.

The entry of new providers of such services in Portugal is also noteworthy, thus contributing to the improvement of the quality and availability of home respiratory care services in Portugal.

Closing note

The legal framework for home respiratory services in Portugal has evolved significantly, resulting in a more efficient, patient-centred system. The 2013 contractual model for the provision of such services, promoted by the SPMS, was innovative, which drove competition and improved service quality, with geographic equity and universality achieved in regard to access by patients of the National Health Service to all of the therapies within the scope of home respiratory care offered by various providers. The recent improvements introduced by the current Framework Agreement for the provision of home respiratory care are also significant and emphasise the role of the patient and treatment adherence.

Notes