Lisbon, Feb. 18, 2021 (Lusa) – Infarmed, Portugal's medicines regulator, will coordinate about 20 technical meetings with member states in the coming months to draw lessons from the pandemic, to define proposals to strengthen the strategic autonomy of the European Union in the production and supply of medicines.

"We intend to work at the level of various groups that we will coordinate, with technical and strategic profiles, and address the strengthening of the autonomy of the European Union itself, identifying concrete proposals to strengthen supply chains," said Rui Santos Ivo, president of Infarmed.

As part of the priorities of the Portuguese presidency of the Council of the European Union in the area of medicines, Rui Santos Ivo said that Portugal intends to contribute to concrete solutions to strengthen the role of countries in areas where the pandemic "came to give more visibility", such as the availability of medicines and medical devices.

"It's a lesson from the pandemic that reinforces the importance that, in critical areas, there can be greater coordination between the EU itself, ensuring that there is a contribution of all member states to ensure this strengthening".

All EU Member States "will benefit from being able to reinforce their installed capacity in terms of production units of medicines and medical devices", being necessary to take care of regulatory and legislative aspects in this matter.

He said that over the next six months, the Portuguese presidency intends to work on a proposal to define medicines considered critical, which could lead to the creation of strategic reserves in the EU, essential for the functioning of health systems in situations such as the pandemic.

With the aim of contributing to an EU that is less dependent on the outside in this area, "we are going to identify aspects that can help this response, specifically in terms of supply capacity and the identification of critical medicines," he said.

Another of the Portuguese presidency's priorities has to do with the future Pharmaceutical Strategy for Europe, in which Infarmed intends to assume the role of mediator in order to advance in its implementation based on the three objectives defined, access, sustainability and availability of medicines and medical devices in the EU.

Infarmed will also promote discussion on the European Commission's proposal for a new regulation for the European Medicines Agency (EMA), in areas such as coordination to avoid drug shortages and new methodologies for evaluation in critical situations, such as the continuous evaluation of vaccines against Covid-19.

"These aspects are very much the result of concrete experience and have been reflected in the proposed Regulation. We will promote this discussion, giving an impulse for this to be achieved, with proposals that make sense so that coordination between the EMA and national agencies is strengthened allowing it to be more effective in responding to needs," he said.

The work will culminate in a European conference to define a set of conclusions that will serve as recommendations from the Portuguese presidency "so that they can be developed and give rise to concrete measures" in the area of medicine.

PC/AYLS // AYLS

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