Impact on the Pharmaceutical and Medical Devices Industries

On 11 March 2020, the WHO declared the existence of a COVID-19 pandemic. On that very same day, the Minister of Health enacted Order 3219/2020, of 11 March 2020 (the “Order 3219/2020”), as a response to the anticipated public health emergency. The purpose of this Order is to ensure the conditions for the treatment of this disease in the National Health Service (the “NHS”).

The evolution and quick spread of the disease in Portugal led the Government to enact Decree-Law 10-A/2020, of 13 March 2020, (“Decree-Law 10-A/2020”), which has already undergone several amendments.

Since the beginning of the pandemic, many acts have been published establishing derogatory and temporary measures to deal with the pandemic and the ensuing public health emergency. National legislation in this matter includes many complex and diffuse regulations. Here below, we aggregate and summarise the most relevant measures for the pharmaceutical and medical devices industries, within the on-going pandemic context.

 

The NHS Hospitals’ stockpiling

The enactment of Order 3219/2020 entailed the immediate purchase, by all NHS Hospitals, of medicines, medical devices and personal protective equipment (“PPE”) related to the containment or treatment of COVID-19, to increase their stocks by 20% relative to the consumption of these materials recorded in 2019.

Further to this instruction, the Order 3219/2020 required the immediate purchase of the same medicines, medical devices and PPE by the remaining healthcare units of the NHS and the Ministry of Health, on the same terms and in the same proportion, provided that the use of these products is regular and necessary for each healthcare unit type.

Later on, the Ministry of Health issued Order no. 8057/2020, of 19 August 2020 to re-stock medicines, medical devices and PPE in NHS hospitals, as well as to increase the national strategic reserve of medicines and devices.

 

Streamlined administrative proceedings

For the immediate purchase of health products by SNS hospitals, it was necessary to use faster procurement procedures – presumably, direct award.

Decree-Law 10-A/2020, of 13 March 2020, in its current wording, establishes temporary exceptional rules for public procurement through direct award, notably for the lease and acquisition of assets in connection with COVID-19.

In practice, it enabled the contracts to be awarded by direct award on the grounds of pressing urgency, releasing them from the expenditure authorization requirement and broadening the scope of the simplified direct award proceedings.

Law 1-A/2020, of 19 March establishes that the contracts executed by direct award would not be subject to the prior approval of the Court of Auditors, without prejudice to the maintenance of the obligation to report to the Court. Note that the act is retroactively effective from 13 March 2020.

As a result of these measures, pre-contractual award procedures for contracts in connection with the containment of COVID-19 will be swift and informal, and the companies marketing the relevant products must adjust their response mechanisms to invitations to bid.

In order to streamline the licensing procedures for the industrial manufacturers of medical devices, PPE, ethanol and biocide cleaning products, Decree Law 36/2020, of 15 June established a legal framework for the manufacturing of these products in industrial establishments that do not usually produce them, establishing a simplified system, thus reducing the complexity and bureaucracy associated with this type of procedure.

 

National Testing Strategy for COVID-19 and dissemination of self-testing

The National Health Department (DGS) issued Rule 19/2020 (further amended on 26 March 2020), which regulated and established the National Testing Strategy for COVID-19, based on the principles of "Test, Follow-up, Trace and Isolate". The purpose is thus to identify COVID-19 patients at an early stage; to provide them with adequate clinical follow-up; to ensure effective tracing of patients' contacts, coordinated by public health teams and using the National Epidemiological Surveillance System (SINAVE); and to ensure that the infected patients and their contacts are isolated in a timely manner, thereby controlling the spread of infection by SARS-CoV-2.

Order 2922/2021, of 18 March 2021, established a task force to promote and implement the National Testing Strategy, to draft a management plan for the strategic testing stockpile, to ensure the registration and monitoring of results, to report and provide information to the population on the importance of mass testing for COVID-19, and to promote coordination with the Health Authorities and competent Regional Health Administrations.

In order to intensify and extend screening, Ordinance 56/2021, of 12 March 2021, established a derogatory and temporary regime to allow the population to access rapid antigen tests ("TRAg"), which can now be used by the general public. The TRAg tests covered by this derogation regime are listed on Infarmed's website. They can now be made available to health system units and be sold in pharmacies and licensed over-the-counter sales points, as well as in other locations to be defined by the competent Government body. According to Ordinance 56/2021, the necessary procedures, decisions and recommendations to place these rapid antigen tests on the national market are urgent and a priority.

As a result of the Ordinance, Joint Information Circular Letter 005/CD/100.20.200, of 19 March, established the criteria to include TRAGs tests in the derogatory regime, and issued guidelines to streamline their use and the reporting of results to health authorities.

 

National COVID-19 Vaccination Plan

The much-awaited Ordinance 298-B/2020, setting up and implementing the National COVID-19 ("PNV COVID-19") Vaccination Plan through the National Health Service ("NHS"), was published in Diário da República (Official Gazette) on 23 December 2020.

The Ordinance does not detail the Vaccination Plan, as its content is mainly functional and programmatic.

It is functional because it tasks the Direção-Geral de Saúde (Directorate-General for Health), in its capacity as coordinator of the National Vaccination Plan, with implementing the procedures applicable to the National COVID-19 Vaccination Plan ("PNV COVID-19") by means of a Standard.

And it is programmatic because it states that the PNV COVID-19 is a universal, free, acceptable and feasible plan that pursues the following public health objectives:

a) Reduce COVID-19-related mortality and hospitalizations;

b) Control outbreaks, particularly among vulnerable populations;

c) Minimize the impact of COVID-19 on the health system and society.

The order in which these objectives are listed is not indifferent. The vaccine is expected to be used first as prophylaxis for citizens at risk, preventing them from contracting the disease; then, in reaction to or prevention of outbreaks, preventing the spread of the disease among certain groups or populations; finally, as a buffer against contagion, slowing down the pace and likelihood of infection.

PNV COVID-19 is a dynamic and progressive program, i.e. it adapts to the evolution of scientific knowledge and to the epidemiological situation. The Directorate-General for Health ("DGS") issued Rule 002/2021, further amended on 4 May, to adapt the PNV to a scenario of greater availability of vaccine doses, in order to ensure the vaccination of the largest number of people in the shortest possible period of time.

In this regard, several Council of Ministers Resolutions - the most recent being Resolution 55/2021, of 14 May - allow for an increase in expenditure for the purchase of Covid-19 vaccines, within the context of the European centralized procedure for such purchase.

 

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This information is being updated on a regular basis.

All information contained herein and all opinions expressed are of a general nature and are not intended to substitute recourse to expert legal advice for the resolution of real cases.