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New Health Management Partnerships in Portugal

The Basic Health Law (approved by Law No. 95/2019 of September 4), in its Basis 6, determined that the provision of health care, as a state responsibility, should first be ensured by the Portuguese National Health System (NHS) and other public services.

In this sense, only in a supplementary and temporary manner, and in cases of justified need, agreements may be entered into with private and social sector entities, as well as with professionals in an independent work regime.

Based on this, the recently published Decree-Law no. 23/2020, of May 22, sets forth the rules for the conclusion of management partnership contracts in the health area in Portugal, which will be briefly addressed in this article.

 

Health management partnership contracts

Health management partnerships are agreements entered into with private and social sector entities, with the main purpose of ensuring the management and provision of health care corresponding to a public health service in establishments, or in a part functionally autonomous from them, integrated or to be integrated in the NHS, with transfer and sharing of risks, and may also involve, among others, the activities of design, construction or conservation of that establishment, or of part functionally autonomous from it.

The following aspects of the regime outlined in Decree-Law no. 23/2020 should be highlighted:

(i) The supplementary and temporary nature of these management contracts;

(ii) The conclusion of these contracts depends on the existence of a justified need, and this requirement must be demonstrated in a study, to be conducted by the Central Administration of the Health System and by the Regional Health Administration with territorial competence, approved by the Government member responsible for the health area after public consultation;

(iii) The aforementioned study shall integrate considerations regarding the needs of the users in the respective geographical area; the existing offer in the area and the possibility of concluding agreement contracts to meet the needs and also the time frame for the NHS, without resorting to partnership contracts, to be able to meet the verified needs.

(iv) The previous reference to a 30-year term for the management contract (with the possibility of its extension) has been removed, it now being determined that, due to the temporary nature of these contracts, they may only be renewed by means of a new study, which justifies the non-satisfaction of the needs within the previously established term.

The health management partnership contract, in accordance with Decree-Law 23/2020, shall establish the following aspects:

(i) The ancillary activities that the management entity may pursue;

(ii) The possibility of using the establishment to perform health services outside the scope of the public service it ensures, provided that such use does not jeopardize the fulfilment of public service obligations; and

(iii) the revenues that shall be considered as remuneration of the management entity, particularly the ones resulting from services provided to third parties in the context of ancillary activities or services not intended for the generality of users.

 

Management Entities

The management entities responsible for the management of the healthcare establishment, which is the object of a partnership agreement, shall be commercial companies with head office and main administration located in Portugal, whose exclusive object is the exercise of the activity which is the object of the agreement.

It should be noted that while the previous law on this matter (the now revoked Decree-Law no. 185/2002) referred merely to the guarantees of suitability, technical qualification and financial capacity as guiding principles of the management entity, the current Decree-Law no. 23/2020 lists, as applicable to management entities, the set of public management principles to which the other entities comprising the NHS are subject to.

 

This Decree-Law came into force on 23 May but does not apply to partnerships whose contracting process began before this date.

By analysing this new contracting regime it is possible to conclude that it leaves aspects unregulated such as the program of the procedure and specifications or the financing of the managing entity, which were foreseen and regulated in the already revoked Decree-Law no. 185/2002. Complementary legislation to develop the regime established in Basis 6 of the Health Law will be approved at a subsequent moment.

It should also be noted that the requirements listed in the regime of Decree-Law no. 23/2020 for the contracting of public-private partnerships seem to be in line with what is defined in the aforementioned Basis 6 of the Basic Health Law, which restricts the conclusion of these contracts to cases of justified need and merely on a temporary and exceptional basis.

 

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Caiado Guerreiro’s Health and Pharmaceutical Law team is available for any clarification on this matter.

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Newsletter Life Siences Nº1

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Newsletter May 2020

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Articles Covid-19

Medical Devices and Personal Protective Equipment: An Exceptional and Temporary Regime in Portugal

Decree-Law No. 14-E/2020, of April 13, establishes an exceptional and temporary regime for the design, manufacture, import, national commercialisation and use of medical devices (“MD”) for human use and of personal protective equipment (“PPE”) in Portugal. Said Decree-Law shall take effects as of March 13, 2020.

This exceptional and temporary regime was put in place to help tackle the current shortage of certified MD and PPE available in Portugal, being that the rapid dissemination of the new coronavirus has led to an exponential demand for said products.

As a rule, the design, manufacture, import, placing on the market and use of these products within the European area are subject to conformity assessment procedures. Where the conformity requirements are met, the CE marking is affixed to the products concerned. This assessment shall also be accompanied by surveillance procedures of compliance carried out by the competent authorities.

At the same time, there has been a mobilization of the national business fabric, as well as of the civil society, in a joint effort of fighting the COVID-19 pandemic. This has been possible with the redesign of the supply chains but also with the promotion of initiatives of collection and donation of such products. This increased supply shall be fed into the market without undue delays, otherwise, the efforts made by the industry stakeholders will not have the desired effects.

At a European level, the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat invites all economic agents throughout the supply chain, notified bodies and market surveillance authorities to arrange all measures needed to support the efforts aimed at ensuring that the supply of PPE and MD throughout the EU market will match the continuously increasing demand. However, these measures should not jeopardize the health and safety levels of the MD and PPE, placed on the EU market.

General Rule of Compliance

Decree-Law No. 14-E/2020 establishes a general rule of compliance, according to which:

1. The manufacture, import and placing on the domestic market of MD and PPE aimed at preventing the spread of COVID-19 shall follow the same conformity assessment procedures from which results the CE marking and the issuing of an EU declaration of conformity.

2. During the outbreak of COVID-19, the adaption or derogation from conformity procedures shall only be applicable to the products listed in said Decree-Law, namely, surgical masks to be used by health professionals, of single use and reusable; surgical masks for social use, of single use and reusable; single use gloves; protection goggles; visors and swabs.

Imports of Medical Devices and Personal Protective Equipment without CE marking

MD and PPE that are needed in the prevention of the dissemination of COVID-19 without the CE marking may be imported provided that these are accompanied by certificates or other documents demonstrating compliance with health, safety and performance rules adopted by other States, equivalent to those required by EU Regulations and in accordance with a list prepared by the INFARMED (the Portuguese Drug Authority) related with MD and by the ASAE (the Portuguese Food and Economic Security Authority) in relation to PPE.

Products that do not fulfil the abovementioned requirements shall present the necessary documentation for verification. These shall only be imported upon prior favourable decision from the INFARMED or the ASAE. This verification shall be requested by the importer and it shall be issued within four working days. The decision period may be extended once, for the same period, should it prove necessary to consult other entities.

The AT (Tax and Customs Authority) shall provide the INFARMED and the ASAE, in a fortnightly frequency, a list containing information on the quantity of products imported and their type, by reference to the import declarations submitted in each period.

Placing and Making Available on the Market Medical Devices and Personal Protective Equipment

Provided that the requirements for placing products on the market have been met, MD and PPE imported or manufactured in accordance with the provisions of Decree-Law No. 14-E/2020 as well as masks for social use, may be made available:

(a) to health system units and other entities that have adequate sanitary supervision;
(b) for sale in pharmacies and authorised points of sale.

Provided that the requirements for placing products on the market have been met, respiratory protection semi-masks, social use masks and single-use gloves, imported or manufactured in accordance with the provisions of Decree-Law No. 14-E/2020, may be freely placed on the market for sale in wholesale, retail outlets and in vending machines.

*****
Caiado Guerreiro’s Health and Pharmaceutical Law team is available for any clarification on this matter.

Categories
Articles Covid-19

Medical Devices and Personal Protective Equipment: An Exceptional and Temporary Regime in Portugal

Decree-Law No. 14-E/2020, of April 13, establishes an exceptional and temporary regime for the design, manufacture, import, national commercialisation and use of medical devices (“MD”) for human use and of personal protective equipment (“PPE”) in Portugal. Said Decree-Law shall take effects as of March 13, 2020.

This exceptional and temporary regime was put in place to help tackle the current shortage of certified MD and PPE available in Portugal, being that the rapid dissemination of the new coronavirus has led to an exponential demand for said products.

As a rule, the design, manufacture, import, placing on the market and use of these products within the European area are subject to conformity assessment procedures. Where the conformity requirements are met, the CE marking is affixed to the products concerned. This assessment shall also be accompanied by surveillance procedures of compliance carried out by the competent authorities.

At the same time, there has been a mobilization of the national business fabric, as well as of the civil society, in a joint effort of fighting the COVID-19 pandemic. This has been possible with the redesign of the supply chains but also with the promotion of initiatives of collection and donation of such products. This increased supply shall be fed into the market without undue delays, otherwise, the efforts made by the industry stakeholders will not have the desired effects.

At a European level, the Commission Recommendation (EU) 2020/403 of 13 March 2020 on conformity assessment and market surveillance procedures within the context of the COVID-19 threat invites all economic agents throughout the supply chain, notified bodies and market surveillance authorities to arrange all measures needed to support the efforts aimed at ensuring that the supply of PPE and MD throughout the EU market will match the continuously increasing demand. However, these measures should not jeopardize the health and safety levels of the MD and PPE, placed on the EU market.

General Rule of Compliance

Decree-Law No. 14-E/2020 establishes a general rule of compliance, according to which:

1. The manufacture, import and placing on the domestic market of MD and PPE aimed at preventing the spread of COVID-19 shall follow the same conformity assessment procedures from which results the CE marking and the issuing of an EU declaration of conformity.

2. During the outbreak of COVID-19, the adaption or derogation from conformity procedures shall only be applicable to the products listed in said Decree-Law, namely, surgical masks to be used by health professionals, of single use and reusable; surgical masks for social use, of single use and reusable; single use gloves; protection goggles; visors and swabs.

Imports of Medical Devices and Personal Protective Equipment without CE marking

MD and PPE that are needed in the prevention of the dissemination of COVID-19 without the CE marking may be imported provided that these are accompanied by certificates or other documents demonstrating compliance with health, safety and performance rules adopted by other States, equivalent to those required by EU Regulations and in accordance with a list prepared by the INFARMED (the Portuguese Drug Authority) related with MD and by the ASAE (the Portuguese Food and Economic Security Authority) in relation to PPE.

Products that do not fulfil the abovementioned requirements shall present the necessary documentation for verification. These shall only be imported upon prior favourable decision from the INFARMED or the ASAE. This verification shall be requested by the importer and it shall be issued within four working days. The decision period may be extended once, for the same period, should it prove necessary to consult other entities.

The AT (Tax and Customs Authority) shall provide the INFARMED and the ASAE, in a fortnightly frequency, a list containing information on the quantity of products imported and their type, by reference to the import declarations submitted in each period.

Placing and Making Available on the Market Medical Devices and Personal Protective Equipment

Provided that the requirements for placing products on the market have been met, MD and PPE imported or manufactured in accordance with the provisions of Decree-Law No. 14-E/2020 as well as masks for social use, may be made available:

(a) to health system units and other entities that have adequate sanitary supervision;
(b) for sale in pharmacies and authorised points of sale.

Provided that the requirements for placing products on the market have been met, respiratory protection semi-masks, social use masks and single-use gloves, imported or manufactured in accordance with the provisions of Decree-Law No. 14-E/2020, may be freely placed on the market for sale in wholesale, retail outlets and in vending machines.

*****
Caiado Guerreiro’s Health and Pharmaceutical Law team is available for any clarification on this matter.

Categories
Articles Covid-19

Exceptional Regime for Electronic Prescriptions in Portugal

Ordinance No. 90-A/2020, of April 9, has just arrived and it brings about an exceptional and temporary regime for electronic prescription of medicines and respective medical prescriptions that will apply during the current period of state of emergency and its possible renewals.

What is the underlying objective here?

The underlying objective here is to ensure the continued access to prescription medicines, particularly for chronically ill patients, being simultaneously in line with the general concern of minimisation of contact between people as a way of reducing the spread of COVID-19.

Is my prescription renewed automatically?

Ordinance No. 90-A/2020 allows for the automatic renewal of electronic prescriptions of medicines that have a six months’ validity and would expire after the date of entry into force of this Ordinance. As such, these will be considered renewed for the same period.

This represents an extension of the renewable medical prescription scheme, being the latter generally applicable to prescription medicines intended for certain illnesses or for long-term treatment, and that, in accordance with its safety use, may be purchased more than once without the need for a new prescription.

Are there any other prescriptions being automatically renewed?

In addition, the following prescriptions are also renewed:

• Medicinal products with the pharmacotherapeutic classification of the group 4.3.1.4 – “Other Anticoagulants”;
• Dietary products indicated to meet the nutritional needs of patients affected by congenital metabolism errors;
• Food and food supplements prescribed to children with respiratory, neurological and/or dietary sequelae secondary to extreme prematurity;
• Co-funded medical devices intended for long-term treatment.
It should also be noted that the new expiry date for the automatically renewed prescription should be counted from the date of expiry of the initial prescription.

Are there any changes to the way in which the medicines will be dispensed?

Ordinance No. 90-A/2020 also provides for an exceptional dispensation regime, applicable to situations in which it is not possible to dispense the prescribed medicine or other of a lower price. In this case, the pharmacist shall dispense the medicine available in stock with the lowest price and report the occurrence.
Also, medicines prescribed electronically on 6-month validity prescriptions cannot be completely dispensed at a single time, as pharmacies should only dispense the necessary parcels to carry out the treatment for up to two months.
*****
Caiado Guerreiro’s Heath and Pharmaceutical Law team is available for any clarification on this matter.

Categories
Articles Covid-19

Exceptional Regime for Electronic Prescriptions in Portugal

Ordinance No. 90-A/2020, of April 9, has just arrived and it brings about an exceptional and temporary regime for electronic prescription of medicines and respective medical prescriptions that will apply during the current period of state of emergency and its possible renewals.

What is the underlying objective here?

The underlying objective here is to ensure the continued access to prescription medicines, particularly for chronically ill patients, being simultaneously in line with the general concern of minimisation of contact between people as a way of reducing the spread of COVID-19.

Is my prescription renewed automatically?

Ordinance No. 90-A/2020 allows for the automatic renewal of electronic prescriptions of medicines that have a six months’ validity and would expire after the date of entry into force of this Ordinance. As such, these will be considered renewed for the same period.

This represents an extension of the renewable medical prescription scheme, being the latter generally applicable to prescription medicines intended for certain illnesses or for long-term treatment, and that, in accordance with its safety use, may be purchased more than once without the need for a new prescription.

Are there any other prescriptions being automatically renewed?

In addition, the following prescriptions are also renewed:

• Medicinal products with the pharmacotherapeutic classification of the group 4.3.1.4 – “Other Anticoagulants”;
• Dietary products indicated to meet the nutritional needs of patients affected by congenital metabolism errors;
• Food and food supplements prescribed to children with respiratory, neurological and/or dietary sequelae secondary to extreme prematurity;
• Co-funded medical devices intended for long-term treatment.
It should also be noted that the new expiry date for the automatically renewed prescription should be counted from the date of expiry of the initial prescription.

Are there any changes to the way in which the medicines will be dispensed?

Ordinance No. 90-A/2020 also provides for an exceptional dispensation regime, applicable to situations in which it is not possible to dispense the prescribed medicine or other of a lower price. In this case, the pharmacist shall dispense the medicine available in stock with the lowest price and report the occurrence.
Also, medicines prescribed electronically on 6-month validity prescriptions cannot be completely dispensed at a single time, as pharmacies should only dispense the necessary parcels to carry out the treatment for up to two months.
*****
Caiado Guerreiro’s Heath and Pharmaceutical Law team is available for any clarification on this matter.

Categories
Articles Covid-19

How to Manage Clinical Trials in Portugal during the COVID-19 pandemic

Following the declaration by the World Health Organization of a world health emergency due to the infection by SARS-CoV-2 (new coronavirus 2019), the Portuguese Drug Agency (INFARMED) has published a set of exceptional measures related with clinical trials that shall be in force during the current period of risk to the public health, in order to guarantee the rights and safety of the clinical trials’ participants.

The reduction of the risk of propagation of the infection among the population as well as ensuring the availability of health professionals to perform priority tasks are some of the objectives of the newly issued recommendations.

In March, the European Medicines Agency (EMA) had already announced that it would provide full fee waivers for scientific advice applications from developers of potential therapeutics or vaccines developed against COVID-19.

In this sense, the INFARMED will also prioritize the evaluation of new clinical trials designed to treat or prevent the new coronavirus disease. Applicants shall submit the study through the National Register of Clinical Trials (RNEC), clearly identifying that the subject is Covid disease19, and sending an email to the INFARMED (ensaios.clinicos@infarmed.pt) and to the Ethics Commission for Clinical Research (CEIC) (ceic@ceic.pt), in order to speed up the process in view of an expeditious approval.

The following set of measures are recommended by the INFARMED for clinical trials already underway:

Suspension of recruitment

The recruitment activity should be suspended whenever it justifiably carries an additional risk of SARS-CoV-2 infection for the patients to be recruited.

In addition, there may be a need for the immediate interruption of the study treatment, whenever the safety of the participants is at stake – in particular if the clinical test involves immunosuppressive patients (with a debilitated immune system due to the treatment under study) or other therapies which may pose an intolerable risk. The study sponsor should notify the INFARMED of the interruption of the study as an “urgent safety measure”, with a detailed explanation of the context, and the measures taken to ensure the alternative treatment for participants.

Scheduled visits

The sponsor should assess the need to revise the visits’ plan adopted in the study, with the purpose of:

• Adjusting the frequency of the visits for the period considered necessary.
• Adjusting the level of information collected during each visit.
• Distance visits using telematic means, if consented by the participant, should also be possible. The collection and recording of all the information planned for the visit should be ensured, but only the strictly necessary information should be collected.

Centralised monitoring

The sponsor should assess the need to revise the monitoring plan adopted with the purpose of:

• Postponing face-to-face monitoring visits.
• Conducting centralised monitoring visits, based on a risk assessment, something that is permitted and encouraged.
• Reducing monitoring activities to what is feasible from a distance.

A further note to emphasise that the centralised monitoring shall not permit the withholding of source documents or the access to personal data by unauthorised persons. Compliance with Good Clinical Practices in this area and General Data Protection Regulations should be guaranteed.

Direct home dispensing of experimental medicines

Given the exceptional circumstances, experimental medicines may be dispensed at home. Among other recommendations made by the INFARMED, the Leading Researcher and the research team shall maintain oversight of this process, specifically by guaranteeing communication routes that allow the clarification of doubts by the participants. Additionally, the patient shall receive all information and shall be aware of the administration and surveillance process, having the necessary contacts to report adverse effects/serious adverse effects

Conditions for transfer between test centres:

Given the exceptional circumstances, transfer between trial sites may be accepted, in compliance with the applicable regulation, namely Good Clinical Practices, General Regulation of Data Protection, and with any other deontological aspects related with the transfer of documents between health institutions.

Categories
Articles Covid-19

How to Manage Clinical Trials in Portugal during the COVID-19 pandemic

Following the declaration by the World Health Organization of a world health emergency due to the infection by SARS-CoV-2 (new coronavirus 2019), the Portuguese Drug Agency (INFARMED) has published a set of exceptional measures related with clinical trials that shall be in force during the current period of risk to the public health, in order to guarantee the rights and safety of the clinical trials’ participants.

The reduction of the risk of propagation of the infection among the population as well as ensuring the availability of health professionals to perform priority tasks are some of the objectives of the newly issued recommendations.

In March, the European Medicines Agency (EMA) had already announced that it would provide full fee waivers for scientific advice applications from developers of potential therapeutics or vaccines developed against COVID-19.

In this sense, the INFARMED will also prioritize the evaluation of new clinical trials designed to treat or prevent the new coronavirus disease. Applicants shall submit the study through the National Register of Clinical Trials (RNEC), clearly identifying that the subject is Covid disease19, and sending an email to the INFARMED (ensaios.clinicos@infarmed.pt) and to the Ethics Commission for Clinical Research (CEIC) (ceic@ceic.pt), in order to speed up the process in view of an expeditious approval.

The following set of measures are recommended by the INFARMED for clinical trials already underway:

Suspension of recruitment

The recruitment activity should be suspended whenever it justifiably carries an additional risk of SARS-CoV-2 infection for the patients to be recruited.

In addition, there may be a need for the immediate interruption of the study treatment, whenever the safety of the participants is at stake – in particular if the clinical test involves immunosuppressive patients (with a debilitated immune system due to the treatment under study) or other therapies which may pose an intolerable risk. The study sponsor should notify the INFARMED of the interruption of the study as an “urgent safety measure”, with a detailed explanation of the context, and the measures taken to ensure the alternative treatment for participants.

Scheduled visits

The sponsor should assess the need to revise the visits’ plan adopted in the study, with the purpose of:

• Adjusting the frequency of the visits for the period considered necessary.
• Adjusting the level of information collected during each visit.
• Distance visits using telematic means, if consented by the participant, should also be possible. The collection and recording of all the information planned for the visit should be ensured, but only the strictly necessary information should be collected.

Centralised monitoring

The sponsor should assess the need to revise the monitoring plan adopted with the purpose of:

• Postponing face-to-face monitoring visits.
• Conducting centralised monitoring visits, based on a risk assessment, something that is permitted and encouraged.
• Reducing monitoring activities to what is feasible from a distance.

A further note to emphasise that the centralised monitoring shall not permit the withholding of source documents or the access to personal data by unauthorised persons. Compliance with Good Clinical Practices in this area and General Data Protection Regulations should be guaranteed.

Direct home dispensing of experimental medicines

Given the exceptional circumstances, experimental medicines may be dispensed at home. Among other recommendations made by the INFARMED, the Leading Researcher and the research team shall maintain oversight of this process, specifically by guaranteeing communication routes that allow the clarification of doubts by the participants. Additionally, the patient shall receive all information and shall be aware of the administration and surveillance process, having the necessary contacts to report adverse effects/serious adverse effects

Conditions for transfer between test centres:

Given the exceptional circumstances, transfer between trial sites may be accepted, in compliance with the applicable regulation, namely Good Clinical Practices, General Regulation of Data Protection, and with any other deontological aspects related with the transfer of documents between health institutions.

Categories
Articles Covid-19

Exceptional Measures to Facilitate Public Procurement in the Health Sector in Portugal

Go, go, go! Portugal has approved exceptional and temporary measures in the context of the Coronavirus – COVID 19, which include exceptional rules for Public Procurement aimed at the Health Sector.

What is this about?

It is all about simplifying and speeding-up the procedures associated to the purchases that are needed in response to the COVID-19 disease. Direct awarding of contracts is generally authorised, and the threshold for simplified direct awarding of contracts is raised to €20.000,00, with derogations on the repeated direct awarding to a specific supplier.

What is it for?

The procedures for awarding of public contracts aimed at satisfying the specific needs of the awarding entities in relation to prevention, containment, mitigation and treatment of the COVID-19 disease, as well as the return to a normal life following such epidemy, are all comprised in this exceptional regime.

Purchase of goods & services and execution of works are typical situations to which this exceptional regime can apply.

Who can use it?

State companies, State administration and, with some adjustments, local municipalities can resort to this exceptional regime. Public hospitals, the Ministry of Health, the Regional Health Administration and others are therefore included.

Can awarding entities make advance payments to contracted parties?

Awarding entities may make advance payments on account of future deliveries or on account of preparatory or accessory acts, without the limitations normally in place (e.g. the 30% of the purchase price limitation).

Can awarding entities make purchases outside of mandatory framework contracts?

Normally the entities that are part of the National System of Public Purchase have to make their purchases in the context of centralized framework agreements where those centralized framework agreements exist, a Governmental authorisation being required for those entities to release themselves from such obligation. This requirement to ask for prior authorisation seems to have been set aside, meaning that the purchasing entities appear to be free to release themselves from their framework agreements.

Do these contracts need to meet publicity requirements before entering into force?

The awarded contracts can produce their effects immediately, publicizing being done subsequently.

Are these contracts subject to prior screening from the Court of Audits?

No, the contracts encompassed by this exceptional regime shall produce their effects immediately, including as regards payments, with no need for prior screening by the Court of Auditors.