When the Covid-19 pandemic hit Europe in 2020, the Portuguese Government took the opportunity to establish the health sector as a strategic asset. At that time, the State Budget Law for 2020 announced the creation of the National Medicines Laboratory, part of the Army structure, to carry out duties of the Ministry of National Defence and the Ministry of Health.
As a declaration of principle, the Laboratory was to be entrusted with the research and production of medicines, medical devices, and other health products, with the purpose of reducing the country’s dependence on the pharmaceutical industry and affirming national sovereignty in this area.
It took almost a year of addressing more pressing issues for the final step to finally be implemented – the approval of the National Medicines Laboratory legal framework, which came into force from the 11th of February 2021.
The Laboratory is created as an investment in national production in the medicines sector, guaranteeing the strategic production of essential medicines and fulfilling needs unmet by the pharmaceutical industry. It further promotes the national scientific and technological system in medicines, encouraging public research and therapeutic innovation.
Notably, the Laboratory will:
- manufacture medicines that are not authorized or marketed in Portugal and that are essential in hospital clinical practice;
- manufacture medicines whose normal supply is at stake (orphan drugs and generics most used in the treatment and prevention of diseases with a higher prevalence in Portugal);
- contribute to the production of vaccines;
- manufacture and supply drugs to the National Health System;
- manufacture cannabis plant-based drugs, preparations and substances;
- distribute medicines and other health products.
The Laboratory is deemed subject to the regulation from the national regulatory authority of medicines and health products (Infarmed) and its activities must comply with existing legal and technical inspection requirements contained in the applicable regulatory framework. However, the approved legislation determines the Laboratory may carry out all the activities listed above without holding authorisations or licenses granted by Infarmed, and is exempt from paying fees for medicine manufacturing activities, thus sparing this body from significant hurdles other market players have to overcome.
We watch with caution as the Government creates an all-around player capable of being entrusted with several tasks in the health products value chain normally fulfilled by pharma and medical devices companies, manufacturers, wholesale distributors, and logistics operators.
One cannot ignore that the newly approved Decree-Law contains several references to strategic production and strategic reserve and liaises its policy options with emergency epidemic or pandemic situations, which should not be viewed lightly. Though these are demanding times and an 'all hands on deck' attitude is pivotal for the success of the fight against the coronavirus, it is important to guarantee that the activities carried out by this Laboratory do not replace nor meddle in the private sector. Indeed, we cannot disregard the fact that the proposal to create the Laboratory stated that its establishment would “allow the State to no longer be held hostage of the pharmaceutical industry”. This forces us to wonder: will the pharmaceutical industry be held hostage of the State?
See the Decree-Law in full here: https://dre.pt/web/guest/pesquisa/-/search/156974201/details/maximized