European Medicines Agency

The European Respiratory Society appreciates the opportunity to give input to the proposal on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices.

As a leading global pharmaceutical company, Teva provides medicines to more than 200 million patients around the world every day. Ensuring patients get access to their treatments when they need them is at the heart of our mission. Therefore, addressing and preventing shortages and guaranteeing security of supply is a priority for Teva, including during health emergencies situations.

Industry and Sanofi have doubled their efforts throughout the COVID 19 pandemic to mitigate risks of shortages by increasing production and reallocating stocks where highest needs were identified. However, we have seen supply chain disruptions of critical medicines and medical devices.

It is greatly welcomed that the mandate of the European Medicines Agency is proposed to be updated in light of the experience of the COVID-19 pandemic. Given the enormity of the pandemic’s impact, including for cancer patients across Europe, we cannot afford not to learn the lessons of 2020’s events rapidly and make necessary changes.

The European Federation of Allergy and Airways Diseases Patients’ Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. EFA is member at the EMA Patients’ and Consumers’ Working Party (PCWP), therefore having first-hand experience of the agency’s strong engagement with stakeholders.

The European Federation of Allergy and Airways Diseases Patients’ Associations (EFA) is the voice of 200 million people living with allergy, asthma, and chronic obstructive pulmonary disease (COPD) in Europe. EFA is member at the EMA Patients’ and Consumers’ Working Party (PCWP), therefore having first-hand experience of the agency’s strong engagement with stakeholders.

Attached please find the feedback of the European Association of Hospital Pharmacists (EAHP) on the “Proposal for a Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices”.

The Association of the European Self-Care Industry (AESGP), representing the European manufactures of consumer healthcare products (including non-prescription medicines and selfcare medical devices), would like to use the opportunity provided by the Commission to comment on the draft Regulation on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and…

The European Union and all its Member States have ratified the United Nations Conventions on the Rights of Persons with Disabilities (CRPD). This international treaty creates specific obligations relevant for the EU and all Member States in the creation of the European Health Union Package.

Edwards Lifesciences is a global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring for critically ill patients. Edwards Lifesciences EMEACLA welcomes the EU Commission’s initiative to strengthen the role of the European Medicines Agency (EMA) to better address public health emergencies.

The COVID-19 pandemic has clearly shown that there are opportunities to further strengthen and improve the EU health security framework to be ready for all health threats. Therefore, Johnson & Johnson (J&J) welcomes and supports the EU’s goal to equip the EMA with a stronger mandate.

The proposal for a regulation provides for enhanced competences of the EMA in the event of an EU health emergency or major event threatening the supply of medicinal products. In this case, EMA will be able to monitor the supply of much-needed medicines and medical devices.

Filed in German · English published by the European Commission

In general, BAH welcomes the transfer of coordinating, advisory and supporting tasks to the EU or the EMA respectively in certain defined (crisis) situations, particularly in connection with combating shortages. In order to secure production and supply, unilateral national measures such as restrictions on the free movement of goods, export bans or similar measures must be avoided.

The European Society of Cardiology (ESC) supports the initiative to reinforce the mandate of European Medicines Agency (EMA) to enable the Agency to lead a more effective response to health crises, both caused by communicable and non-communicable diseases. The ESC and National Cardiac Societies across Europe share the goal of reducing the burden of cardiovascular disease (CVD).

EPF welcomes the proposal to extend the EMA’s mandate and resources. The EMA plays an important role in protecting public health in the EU. We believe it does not go far enough and can be improved. > Addressing medicines shortages Shortages are a systemic problem that predates COVID-19, though it was brought into relief by the pandemic.

Regaring the proposed Regulation on the reinforced role of EMA, MedTech Europe suggests to take the following considerations into account (full position attached): 1. Involvement of Civil Society in the Executive Steering Committee on Medical Devices (Art19): a.COVID-19 has demonstrated the need to involve the medical technology industry and other partners of civil society in an ongoing dialogue throughout the full…

The European Safety Federation (ESF) welcomes the European Commission proposals on “European Medicines Agency – strengthened role to address public health emergencies”. Being the European organisation representing the Personal Protective Equipment (PPE) suppliers, ESF is very much pleased by the Commission’s intention to devote proper support to the European health system, especially with the unprecedented COVID-19…

GIRP welcomes the proposed regulation on a reinforced role for the EMA in crisis preparedness and management for medicinal products and medical devices. GIRP believes that EU coordination is key to addressing the issue of medicine shortages in times of crisis and we are convinced that the EMA is well-fitted to monitor and mitigate potential and actual shortages for the duration of a public health emergency or major…

EFPIA fully supports the EU’s goal to enhance its health emergency preparedness and response capacity by, among others, extending the mandate of the EMA. The current crisis has shown the importance of close dialogue between EU authorities and the industry, to address medicines’ shortages.

The COVID-19 pandemic revealed the need for improvement in Europe’s capacity to respond to public health emergencies. Vaccines Europe (VE), a trade association representing the major innovative research-based vaccine companies as well as small and medium sized enterprises operating in Europe welcomes the Commission’s proposal to complement and further develop the core tasks of the EMA, to enhance the Union's…

The European Social Insurance Platform (ESIP), representing statutory social security institutions in the EU, in Switzerland and the UK, welcomes the legislative proposals on strengthening crisis preparedness. While Member States are responsible for the definition of national health policies, we believe that situations of common public health concern require coordinated actions and cooperation.

APOGEN, taking into account to the lessons learned from COVID-19 crisis, believes that the proposal on management and mitigation of medicines shortages should be improved for better outcomes of the collaboration between the manufacturers and National and European medicines agencies to improve the supply of medicines to patients and to ensure EU solidarity.

Medicines for Europe, taking into account to the lessons learned from COVID-19 crisis, believes that the proposal on management and mitigation of medicines shortages should be improved for better outcomes of the collaboration between the manufacturers and National and European medicines agencies to improve the supply of medicines to patients and to ensure EU solidarity.

STADA, taking into account to the lessons learned from COVID-19 crisis, believes that the proposal on management and mitigation of medicines shortages should be improved for better outcomes of the collaboration between the manufacturers and National and European medicines agencies to improve the supply of medicines to patients and to ensure EU solidarity.

Medicines for Poland, taking into account to the lessons learned from COVID-19 crisis, believes that the proposal on management and mitigation of medicines shortages should be improved for better outcomes of the collaboration between the manufacturers and National and European medicines agencies to improve the supply of medicines to patients and to ensure EU solidarity.

The European Blood Alliance (EBA, www.europeanbloodalliance.eu) welcomes the proposal for a European Medicines Agency (EMA) increased role in crises preparedness and management of Plasma-Derived Medicinal Products (PDMPs) supply.

McKesson Europe fully supports EMA’s extended role in addressing public health emergencies including their new role in monitoring medicine shortages. We also support EMA’s definition of medicine shortages as defined in Art. 2 / (d) of the regulation ( “shortage” means that supply of a medicinal product for human use or a medical device does not meet demand for that medicinal product or medical device”).

SPECTARIS is the German Association of Optics, Photonics, Analysis and Medical Engineering. The Association represents predominantly medium-sized German companies in 400. Consumer Optics, Photonics, Medical Engineering, Analytical, Bio- and Laboratory Engineering had a total turnover of over EUR 73 billion in 2019, employing around 328.000 people.

Filed in German · English published by the European Commission

SPECTARIS is the German Industry Association For Optics, Photonics, Analytical And Medical Technology. The association represents 400 predominantly medium-sized German companies. The consumer optics (ophthalmic optics), photonics, medical technology and analytical, bio and laboratory technology sectors achieved a total turnover of over 73 billion euros in 2019 and employ around 328,000 people.

EUCOPE, the European association with a strong focus on small to medium-sized companies active in pharmaceuticals and biotechnologies, welcomes the Commission’s proposal for a regulation 2020/0321 to reinforce the role of the European Medicines Agency (EMA) in crisis preparedness and management for medicinal products and medical devices.

LERU welcomes the proposal to strengthen the role of the European Medicines Agency to address public health emergencies. We would like to highlight that "regulatory preparedness" can be ensured by putting in place and maintaining a strong evidence/regulatory science base to underpin decision-making.

The European Society of Radiology (ESR) welcomes the European Commission’s proposal to determine a clear framework for the deployment of the activities of the European Medicines Agency (EMA) to monitor and mitigate potential and actual shortages of medicinal products and medical devices.

As the spread of infectious diseases is a long-term, continuous, and evolving threat, Former Eastern Europe Countries may need an agency specifically responsible for preventing and managing biological threats. Former Eastern Europe Countries could consider investing in an agency that can coordinate policy responses for any biological emergency.

As the spread of infectious diseases is a long-term, continuous, and evolving threat, Former Eastern Europe Countries may need an agency specifically responsible for preventing and managing biological threats. Former Eastern Europe Countries could consider investing in an agency that can coordinate policy responses for any biological emergency.