Life Sciences Newsletter No. 1/2022

A new era for the health technology assessment in the EU

The recently approved Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment could open a new “door” to the way of thinking about healthcare in Europe.

The Health Technology Assessment (HTA) process is currently performed by 50 HTA agencies across Europe. Nevertheless, approaches vary from country to country which means a fragmentation of HTA criteria with serious negative impacts on the European health market and patients in its Member States.


Health Technology Assessment (HTA) is a form of a policy that examinates short and long-term consequences of using a healthcare technology. It is a multidisciplinary process that summarizes information about the medical, social, economic, and ethical issues related to the use of a health technology in a systematic, transparent, unbiased, robust manner. This process may be related with Value Base Healthcare, that focuses on health status (outcomes) achieved by a certain treatment and the price the patient must pay for it (costs), in a cost-efficient way.

To support cooperation between HTA agencies, the European Union has made substantial investments by establishing the new Regulation (EU) 2021/2282 of the European Parliament and of the Council Of 15 December 2021.

The process regarding health technology assessment can provide a precious help in assessing the added value of new or existing health technologies – medicines, medical devices and diagnostic tools, surgical procedures, as well as measures for disease prevention, diagnosis, or treatment – compared with other health technologies. HTA can be used not only to guide different authorities about whether a new treatment or other technologies should be available on the national health service, but also to assess if a certain treatment for a certain disease or a specific condition, provides value in terms of health status for that particular patient in a cost-efficient way thus implementing a real Value-based Healthcare system.
To Know more about how the process of Health technology assessment can be related to the concept of Value Base Healthcare please check our article in this link.

Portugal has more than doubled its health exports in the last decade

According to the Health Cluster Portugal, given the quality of the Portuguese health value chain, as well as the stability, dynamism and resilience in this sector, exports in health grew by 150% in the last decade in Portugal.

The Health Cluster Portugal, citing data from the Agency for Investment and Foreign Trade of Portugal (AICEP) and having as a source the National Statistics Institute (INE), concluded that exports in health grew, in 2020, by 11.11%, in counter-cycle with the Portuguese trade balance that decreased by 10%, compared to 2019.

According to the same entity, “the growth values of health are strongly based on basic pharmaceutical products that increased more than 25% and in pharmaceutical preparations, which grew 11.02%,” referring also that “if in 2019 exports in health exceeded 1,500 million euros, in 2020 they reached 1,749 million,” values that “mirror a sector in permanent growth, even during the pandemic.”

Data from Health Cluster Portugal states that health “represents an annual turnover of around €30 billion and a gross value added of around €9.0 billion, involving nearly 90,000 companies and employing almost 300,000 people”.

These data show the sustained growth of the sector and that health is gaining centrality in Portugal, having registered a remarkable evolution over the last two decades.

European Medicines Agency strengthens its role in crisis management (for medicines and medical devices)

The European Medicines Agency (hereinafter “EMA”) saw its competences reinforced in the area of medicines and medical devices. With the Covid-19 pandemic, and at a time when the access of hospitals and other health agents was heavily conditioned, the European Parliament gives a concrete sign that the EMA will play a key role in access to these goods especially in crisis scenarios, thus approving Regulation 2022/123 of 25 January 2022.

In the words of this Regulation “Addressing the issue of medicine shortages has been a long-standing but unresolved priority for Member States and the European Parliament, as illustrated by several reports of the European Parliament, such as the European Parliament Resolution of 17 September 2020 on medicine shortages.”

The Regulation thus strengthens the powers of this European agency so that it can:

  • Prepare, prevent, coordinate and manage, at Union level, the impact of public health emergencies on medicinal products and medical devices and the impact of serious events on medicinal products and medical devices;
  • Monitor, prevent and report on drug stock-outs and medical device stock-outs;
  • Establish at Union level an interoperable information technology platform to monitor and report on drug outbreaks;
  • Provide advice on medicines that have the potential to respond to public health emergencies

The new Regulation also establishes some obligations regarding the obligations of Marketing Authorisation Holders (MAHs), namely, the Agency may now request MAHs to provide information on the critical medicines they hold, having to justify to this entity the non-provision of this information as well as to immediately inform this body whenever there is an actual or potential disruption of medicines.

Industrial Hemp In Portugal - The most recent legislative amendments

In early 2022 Portugal has introduced relevant changes to the rules on cannabis cultivation for industrial purposes, thus bringing much awaited clarity to this activity.

In order to distinguish between the production of cannabis for medicinal purposes or for industrial purposes, the legislator fixed yearly deadlines (31st of July of each cultivating year) for submitting the authorization request to the Directorate-General for Food and Veterinary Office (DGAV), and adding a subparagraph stipulating that the application must inter alia specify the recipients of the production and which products are to be produced.

Furthermore, article 3-A was added to this Ordinance, establishing the technical requirements applicable to the cultivation of the cannabis plant for industrial purposes.

This is probably the most substantial legislative change, and it is also the one that contributes most to the differentiation between the requirements that need to be met in order to cultivate the cannabis plant for industrial purposes.

These amendments to Ordinance 83/2021 arise from experience gathered with the implementation of legislation relating to the authorisation process for the cultivation of cannabis in Portugal, better detailing procedures and technical requirements applicable to the cultivation of cannabis for industrial purposes so that this cultivation is conducted in the best agronomic conditions and better adapted to this purpose.

These are significant development as regards clarifying the pathway to obtain a license to cultivate and produce cannabis for industrial purposes in Portugal.

To know more about Industrial Hemp in Portugal please check our article in this link.

Refugee Reception in Portugal and Integration into Clinical Trials

With the humanitarian refugee crisis in Ukraine and with Portugal hosting refugees from this country, on April 5th, Infarmed issued an Information Circular (Information Circular N.º 030/CD/100.20.200), regarding the integration of these displaced citizens in clinical trials taking place in that country.

In this Circular, Infarmed points out that some displaced Ukrainian citizens may be participants in clinical trials that are taking place simultaneously or not in different Member States, drawing attention to the fact that it is necessary in this circumstance “to promote the necessary actions or steps in order to allow the continuity of participation in those clinical trials or to ensure the most appropriate medication to their clinical condition”.

In this sense, Infarmed determines that upon arrival of a displaced citizen who was participating in a clinical trial in his country of origin, the national authority must seek to identify the clinical trial, identifying the sponsor responsible for it in order to find out whether the clinical trial is also taking place in Portugal, and immediately integrate the patient into it. If the clinical trial does not take place in Portugal and if the investigational medicinal products do not have the competent marketing authorisation, it must be verified whether there are therapeutic alternatives available on the national market.

With this circular Infarmed is providing clarity on how to proceed in relation to displaced persons who are included in clinical trials, thus establishing that the host country must ensure the continuation of the clinical trial as well as the continuation of medical care needed for patients.

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