This Friday, Infarmed stressed that it had informed the European Commission “in advance and in a timely manner” of the rules on drug export restrictions in force since 2017, and also informed about the 2021 update.
The Portuguese Association of Importers and Exporters of Medicines (APIEM) warned this Friday that measures restricting the export of medicines could be declared inapplicable because Infarmed did not notify the European Commission before they entered into force.
These are the rules on pre-notification of drug transactions abroad, effective from 2021, explained APIEM Secretary General Luse, who says he became aware of the situation after Infarmed notified the European Commission of changes to the rules in November.
Prior notification is an imposition by the European Commission whose purpose is to ensure that any technical regulation that a member state intends to introduce is compatible with European law and avoids obstacles in the internal market and protectionist measures, explained APIEM Secretary General José Tavares de Almeida.
In response to Lusa, Infarmed emphasized that the currently valid Regulation No. 391/2021 of March 19 made some changes to Decision No. and immediately notified the European Commission.
“Despite this, updated information has been communicated to the European Commission (DG Santé),” he stressed.
“This was also the subject of extensive consultation with all partners in this sector in Portugal, who promptly spoke out and commented on the proposal presented,” the national health authority added.
Infarmed also stressed that it controls only those drugs that are not available in Portuguese pharmacies and that are not available to patients in Portugal, adding that this control is provided for by national and European legislation.
“As we know, Europe is currently and in recent years facing a shortage of medicines, and Portugal is no exception. This situation of drug shortages at European level puts increased pressure on the national market for export purposes, which increases the availability of drugs in Portugal.” , he noted.
The National Medicines Authority also stressed that it is important to “protect the interests of Portuguese patients through actions such as granting exclusive marketing authorizations for medicines in a foreign language, regular and continuous collaboration with similar authorities and with companies in the sector to find solutions and, if necessary, , through monitoring and controlling intra-community trade and exports in situations where this poses a risk of worsening the shortage situation in our country.”
APIEM said this Friday that it is studying “what next steps should be taken from a legal point of view in the Portuguese and European cases”, without explaining what hypotheses are under consideration.
José Tavares de Almeida also spoke out against the restrictions imposed by Infarmed, highlighting that since September 2022, the number of products included in the prior notification list, which can only be exported with Infarmed’s permission, has increased by more than 400%. However, this had no effect on solving the supply problems in Portugal.
“In our opinion, (export) is not a problem,” he said, noting the fact that “medicines are not coming in sufficient quantities to meet market needs.”
Referring again to the Infarmed ruling, the APIEM secretary general added that “even the version announced in November has a number of problems related to the lack of proportionality and transparency,” a position that the association conveyed in its opinion to the European Commission.
Author: Lusa
Source: CM Jornal
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