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Initial Assessment of the Impact of Possible Legislative Changes in the Pharmaceutical Sector 

by PLMJ Healthcare, Life Sciences & Phamaceuticals and PLMJ EU and Competition Law

Published: April, 2021

Submission: April, 2021


The COVID-19 pandemic has exposed the difficulties in reacting at European level to a major health crisis and the intention of the European Commission is to respond more effectively to future problems in the area of health. As a result, it is currently conducting an initial assessment of possible legislative changes in the area of medicinal products for human use.

The aim of the legislative changes is to make the European rules more adaptable to new technological developments, to achieve sustainability in production and accessibility to medicines and, above all, to simplify EU procedures relating to medicines. The industry now has the opportunity, until 27 April, to have its say and to help shape the Commission's initial proposal.

The health crisis caused by the COVID-19 pandemic and the difficulties faced in Europe in managing it have led the European Union to seek to review the existing mechanisms in the field of health, particularly in the area of medicines for human use. The new needs and challenges that the world is facing, which have a particular impact on the pharmaceutical sector, have made it necessary to reform the legislation and mechanisms for responding to health crises that may affect the European area in the future.

To this end, on 25 November 2020, the European Union published the Pharmaceutical Strategy for Europe, an ambitious long-term programme that aims to guarantee patients greater access to medicines, stimulate competition between stakeholders, and prepare Member States for future crises. This programme, designed in parallel with the European Health Union, can only be achieved with the legislative revision that is being prepared.

Thus, the European Commission is preparing to assess the EU legislation in the area of medicinal products for human use. This assessment will essentially focus on the general pharmaceutical legislation, including (i) Directive 2001/83/EC (incorporated into Portuguese law by Decree-Law 176/2006 - Legal Framework for Medicinal Products for Human Use; and (ii) Regulation (EC) 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency.

The European Commission will look at the last 16 years to assess whether the objectives pursued by this legislation have been achieved. In particular, it will review the resilience of the existing rules and their ability to respond to the problems identified by the European Pharmaceutical Strategy. The aim is also to assess the consistency and complementarity of these two pieces of legislation with other legislation, and to rethink the mechanisms for adapting technical requirements to emerging technologies.

The assessment now being carried out by the Commission has identified a set of topics that will be taken into account in this initiative:

i) Unmet and market failures that do not fall under the situations of orphan and paediatric medicines;

ii) Unequal access to affordable medicines for patients across the European Union.

iii) The possibility that the legislative framework is not fully prepared to respond quickly to innovation; iv) Inefficiency and excessive bureaucracy in regulatory procedures.

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