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Life Sciences Newsletter No. 3/2021

EU Council green lights the health technology assessment regulation

The Council of the European Union recently gave its green light to the adoption of a Regulation on Health Technology Assessment (HTA), which contributes to better outcomes for patients and is an important tool to ensure the appropriate implementation and use of health technologies.

Pursuant the new rules, patients will be able to access innovative, safe and effective health technologies faster. There will be benefits for manufacturers of medicines and medical devices as submission procedures will be simplified.

To reduce administrative burdens, in particular for smaller companies, health technology developers should only have to submit once at EU level the information, data and other evidence necessary for the joint clinical assessments.

Moreover, Member States’ cooperation in conducting joint clinical assessments, joint scientific consultations and identification of emerging health technologies is foreseen.

This approval means that the Council has adopted its position at first reading. The regulation has still to be adopted by the European Parliament before being published in the Official Journal of the EU.

Price reductions of medicines halted in Portugal for 2022

Ordinance No. 280/2021 was published on December 3rd, revising the annual prices of medicines in the hospital market and the outpatient market in Portugal, under Ordinance No. 195-C/2015, based on the values practised in other countries taken as reference – such as Spain, France, Italy and Slovenia.

The Portuguese Government will again impose an exceptional requirement that aims to avoid a possible sudden fall in the price of medicines in 2022. The underlying rational is to mitigate possible disruptions in the market due to pharmaceutical companies’ lack of interest in producing them, causing supply shortfalls and harming users.

Thus, medicines whose retail price is less than or equal to 15 euros will not have any price reduction. On the other hand, medicines with a retail price between 15 and 30 euros may not see their price reduced by more than 5% and those over 30 euros may not see their price reduced by more than 10%.

As regards generic medicines, as they are subject to the reference price system, for reasons of equity, their price revision remains mandatory.

New law allows postmortem insemination in Portugal

Law No. 72/2021 was recently published, allowing the use of medically assisted procreation techniques through insemination with semen after the donor’s death, in cases of expressly consented parental projects, amending the Medically Assisted Procreation Law and the Civil Code.

This Law entered into force on 13 November and has retroactive application, provided that the existence of a clearly consented and established parental project is proven, in a free and clarified manner regarding all its effects.

Proof of such consent is, in fact, fundamental to the authorisation of the use of genetic material, which may be reduced to writing or recorded on videogram or, failing this, a sworn statement from the doctor accompanying the case confirming the existence of such consent.

With this law, issues regarding inheritance rights were duly clarified and, consequently, the capacity to inherit was extended to all persons conceived within the framework of a post-mortem insemination procedure, and it was provided that the deceased parent’s inheritance shall remain dormant for a period of three years after his death, which is extended until the complete and live birth of the child.

New EU ecolabel criteria for cosmetic and animal care products

The European Commission has adopted the new EU Ecolabel criteria for cosmetic and animal hygiene products, «offering consumers across the EU the benefit of trusted proof of genuine green brands», according to a press release of 22.10.2021.

These criteria aim at encouraging products with reduced impact on ecotoxicity and biodegradability, in which dangerous substances may be present only in small quantities and which use less packaging, which can be easily recycled. The use of recycled materials and refillable packaging is favoured.

The previous criteria only covered rinse-off products, such as liquid soap, shampoo and other body washes. The new EU Ecolabel criteria now cover all cosmetic products, both rinse-off and leave-on, such as creams, oils, skin lotions, deodorants and antiperspirants, sunscreens, as well as hair and make-up products. In addition, producers of animal care products now have the opportunity to apply for the label as a separate product group.

With the strengthened and broadened cosmetic criteria, the EU Ecolabel provides consumers, manufacturers and retailers with a set of reliable criteria that ensure the veracity of the product’s sustainability and live up to their branding claims, contributing to a green and circular economy.

The right to be forgotten when contracting credit and insurance in Portugal

The Portuguese Parliament amended Law 46/2006, of 28 August, as well as the Legal Regime of the Insurance Contract, with the aim of establishing the right to be forgotten for those who have overcome serious illnesses, such as cancer, HIV and diabetes, or disabilities, or who present a situation of mitigation related to those illnesses.

Due to enter into force on 1 January 2022, the law now grants the right to be forgotten when contracting housing credit and consumer credit, as well as when contracting insurance associated with such credit.

Thus, with this legislative amendment it is now established that no health information may be collected in a pre-contractual context by credit institutions and insurers provided that:

  • Ten years have passed without interruption since the end of the therapeutic protocol, in the case of aggravated health risk or overcome disability or;
  • Five years have passed since the end of the therapeutic protocol, in the case of pathology overcome having occurred before the age of twenty-one; or
  • Two years of continuous and effective therapeutic protocol have passed, in the case of aggravated health risk or mitigated disability.

According to the law itself the aim is to “reinforce the access to credit and insurance contracts by people who have overcome or mitigated situations of aggravated health risk or disability by prohibiting discriminatory practices and considering the “right to be forgotten”.

Amendments to the medico-legal examinations regime in Portugal

With effect from 17 June 2021, the legal framework for medico-legal and forensic medical examinations has been amended.

To replace requests for clinical information by post, experts from the National Institute of Legal Medicine and Forensic Sciences (INMLCF) will be able to access the necessary elements existing in the National Health Service or other institutions by electronic means, thus avoiding costs with human resources and postal services, as well as delays in obtaining clinical records essential to the delivering expert opinions.

Autopsies, until now performed only on working days, are now also performed on weekends and holidays, out of respect for the families and in order to minimize the added pain for the relatives waiting for the funeral ceremonies to take place.

The examinations of victims of sexual assault may be carried out, whenever necessary, by two medical experts or by a medical expert assisted by a nursing professional.

The medical doctors hired by INMLCF, I. P. are prevented, within the scope of the expert activity of the court or courts of the district in which the medico-legal and forensic service related to the contract operates, from carrying out other expert interventions in those courts, namely as experts representing insurers or claimants.

Autores:

El contenido desta información no constituye asesoramiento jurídico específico: esto supone una situación concreta claramente definida. Póngase en contacto con nosotros para cualquier aclaración adicional sobre la aplicación de la ley.

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