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The European Medical Association and the role of the European Information and Education actions for favoring better access to effective, novel, high-priced medicines

WHICH VISION FOR COLLABORATION BETWEEN THE PUBLIC AND PRIVATE SECTORS.

Focus on “United Action for Better Health in Europe”.

Announced April 9th 2021

Video-summary in EMANET Channel

Presented by Guglielmo M. Trovato, MD – trovato.eu@gmail.com - Professor of Medicine at the School of Medicine of the State University of Catania, Italy; Director of the Media, e-learning and e-Medicine Bureau at EMA, Brussels

BACKGROUND

EMA announced the Oslo’s Medicine Initiative with a news published in the EU Commission Educational platform (EPALE).

This area of focus for WHO/Europe’s core priority of moving towards universal health coverage is shared with other European Initiatives, such as the proposal of Revision of the EU general pharmaceuticals legislation.  The EU pharmaceuticals strategy, and drawing lessons from the COVID-19 pandemic, is displayed also by Commission plans to evaluate and revise the EU’s general legislation on medicines, aimed for human use to ensure a future-proof and crisis-resistant medicines regulatory system.

The revision will aim to:

• ensure access to affordable medicines

• foster innovation, including in areas of unmet medical need

• improve security of supply

• adapt to new scientific and technological developments

• reduce red tape, i.e. reduce bureaucracy.

.

OSLO’S INITIATIVE

The goal of Oslo’s Medicine Initiative is supporting Member States’ efforts to ensure access for all to medicines, vaccines and health products, implementing World Health Assembly resolution WHA72.8 on transparency.

The objectives are to consult with non-State actors to:

• understand different perspectives on access to effective, novel, high-priced medicines, particularly relating to the current roles and responsibilities of the public and private sectors; and

• receive input on the proposals for the Oslo Medicines Initiative set out in the draft scope and purpose and discussion documents.

The current framework has several critical points, variously perceived and conceptualized by doctors and other health professionals. Our contribution is addressed to this unmet set of information regarding the views of European Medical Doctors, not represented elsewhere in such processes and debates.

 

THE EMA’s SURVEY

The European Medical Association is a not-for-profit more than 30 years old Organization, with expertise in drafting analysis and policy briefs, joining professionally and scientifically qualified members. Their shared background is clinical, i.e. medical practice and teaching at high post-graduate levels, not based on specific management or administrative expertise.

Such features of the contributors potentially and reasonably needed and useful are not explicit even in the document explaining what the European Health Emergency Preparedness and Response Authority (HERA) will or would be, and these features should be well represented, in our view. The European Medical Association may provide contributions, based also on its international experience, networking and knowledge, as detailed in the two articles on Green Pass for sharing recognized COVID-19 vaccine certification, easing free circulation of people in Europe, the EMA’s Monthly Workshop of 24th  March 2021 and the other one, 30 November 2020 The challenge of distilling effective and appropriate targets for enhancing innovation in economy, society and science education in Europe .

 

BASIC DATA

To reach a basic level of information on the field experience of doctors belonging to EMA, we have developed and distributed among our member associates a questionnaire for a basic survey, focusing on three key issues, presented in our video-channel as a synthetic analysis of answers:

The current opinion among the interviewed is that the patents are barriers for drugs and vaccines, being disadvantageous element for public health in the world and therefore for the world economy.

Most interviewed  answered that the patentability of drugs is a condition that can be abolished or mitigated, at least in some specific cases, and this is considered not detrimental to research and the quality of drug production.

For most interviewed it is not clear if there are already legal spaces that in emergency conditions, such as the current pandemic, allow the free production of patented drugs, even with a very short period of validity of the patents themselves (namely a few months / one year) by reducing or eliminating the cost of the related royalties.

 

 

CONCERNS AND ALTERNATIVES

In the current proposals of new EU recommendations, directives or rules, the key point is that an answer to the core question is to be still developed and agreed:

Will an Implementation plan be established? 

The answer is substantially “no”.

There will be no implementation plan prepared in the proposal, as now available, to establish the European Health Emergency Preparedness and Response Authority, lacking even detail on the need to transpose and implement Union legislation for Member States. Actually, no mandatory rules are envisaged. It seems the design of an empty box, without anything to transfer mandatorily to all the Member States, even as a preliminary hypothesis or view.

Overall, Europe seems to be more than a couple of stops late on this journey towards a reliable plan for emergency response readiness, even in comparison with the USA BARDA plan, established ten years ago.

 

CONCLUSION

  • One of the position points that EMA already agrees inside its working groups refers to promote sustainable global health ethics and transparent economy strategy.
  • Political ethics and economy must enhance free cultural interactions at the level of study, research and medical procedures, assuring everywhere and for everybody freedom, human rights for life and health, free mobility, also allowing access to the better possible care.
  • EMA endorses any effort for joining medical professional for assuring affordable delivery of innovative and salvaging medicine as a primary preventive tool, beyond the barriers of patents, if any.
  • Mostly relevant is that European and National Governments clarify if there are already the international legal conditions, secured by International treatises, which will allow overcoming the barriers of patented drugs, at least in specific conditions and still guaranteeing the appropriate gains to producers.
  • Such concepts and information need effective dissemination actions, including a greater specific focus inside the educational-academic schemes, such as the Erasmus actions in Europe. Most teaching actions are still transitorily substituted by e-learning courses and platforms, and are suitable for spreading information actively among members, followers and any sensitive social media network.

Acknowledgement and disclaimer: EMA, being a non-State actor, and a not-for-profit Organization, presents its views slides and this written statement, which will be made public along with a summary report of the issues discussed during the consultation, as personal opinions only. EMA is a partner of the GDPR for Health Project https://gdpr4h-project.eu/  and of the IProcure Security Project https://project.iprocuresecurity.eu/, both funded by the EU Commission. This article is written by Guglielmo Trovato, MD, Professor of Medicine, Director at EMA for Media, e-Learning and e-Medicine. The European Commission even indirect support for the production of this publication does not constitute an endorsement of the contents, which reflect the views only of the author, and the Commission cannot be held responsible for any use, which may be made of the information contained therein.

 

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