Amsterdam   |     |   Members Only

How the European Medicines Agency can adopt a patient-oriented approach

A Science|Business Healthy Measures Half Day High-Level Roundtable, 4 April 2019 (Date TBC), Amsterdam


On 20 November 2017, EU member states decided to relocate the European Medicines Agency (EMA) from London to Amsterdam as a result of the UK's withdrawal from the EU [1].

EMA began working with the Dutch authorities to prepare for the move and take up its operations in Amsterdam from 30 March 2019 at the latest, including the planned relocation of staff to a temporary building. During this period, EMA continues its normal operations. With the Dutch authorities, the EMA has have agreed a joint governance structure to steer and oversee the relocation project.

EMA is essential to the functioning of the single market for medicines in the EU. The agency's work is vital for providing EU citizens with effective, safe and high-quality medicines and maintaining a regulatory environment that fosters innovation and the development of new medicines.

EMA protects human and animal health in 28 EU member states, as well as the countries of the European Economic Area, by ensuring that all medicines available on the EU market are safe, effective and of high quality.

Its fresh start in Amsterdam presents a moment to raise questions about its future role:

Can EMA change its strategy and mission and widen its remits to medical devices?

With the increasing importance of information technology and devices, should agencies such as EMA go beyond the safety of medicines and widen to safety of medical devices and techniques? • Could EMA engage in value-based healthcare reflections and help in ensuring potential benefits outweighing risks? • What are the benefits of using patient outcomes and facilitating personalised medicine approaches, and can EMA take these two aspects into account?What are the possibilities with regards to using and gathering patient data and what are the potential limitations or ethical considerations to using such kind of data? 

Can EMA enhance the benefits of the network for EU citizens?

How could agencies enforce the representation of citizens, patients and care professionals in its European medicines regulatory network?  • How can we enable member states to pool resources and coordinate work to regulate medicines with other medical products and devices (for example by further integration of the Medical Device Coordination Group)?  How can we increase certainty for patients, healthcare professionals, industry and governments through improved standards? How can we further reduce the administrative burden on hospitals and care centres, helping medicines, health products and medical devices to reach patients faster? • How can we further accelerate the exchange of information on important issues, such as the safety of medicines, health products and medical devices?[1]

[1] https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en

 

Objective of the event:

The proposed High-Level Roundtable (HLR) would focus the discussion on how EMA’s relocation from London to Amsterdam could provide impetus to the agency to reorient its strategy, action and regulations to a more patient outcomes centred approach, in line with ongoing reforms in members states, companies and university hospitals. The HLR will focus on these three topics (strategy, action and regulations) by promoting dialogue between main decision-making ministries’ representatives, big and small companies, insurers and social security services, hospitals and patient associations, research organisations and universities.

This event will be held during the ICHOM Conference in May 2019 in Rotterdam.

Science|Business, an experienced convenor of high-level, cross-sector dialogues, will gather these stakeholders to enable open debate among the Healthy Measures members. It will publish a report of the conclusions, and feed those into the work of the Romanian Presidency. A summary of the outcomes could also feed into the reflections and future priorities of EMA and the European Commission.

 

[1] https://www.ema.europa.eu/en/about-us/uks-withdrawal-eu/relocation-amsterdam

[2] https://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework_en

 

Programme
Programme

Welcome

Opening

EMA – a new start, a new strategy

EMA – a new location, a new implementation

Patients at the heart of a new strategy
The European medicines regulatory network is the cornerstone of EMA's work and success, with the Agency operating at the heart of the network, coordinating and supporting interactions between over fifty national competent authorities for both human and veterinary medicines. As for any public authority, the Agency strives towards being as open as possible about how it works and how it comes to its decisions. Transparency is an important feature of EMA's operations. Informing the public on the safety of medicines and cooperating with external parties, in particular representatives of patients and healthcare professionals is vital. But how can EMA engage in involving, integrating patients and healthcare professionals, in taking patient outcomes into account, in including value-based healthcare principles and favour personalised medicine through its strategy?

A new healthcare ecosystem
EMA plays a role in supporting research and innovation in the pharmaceutical sector, and promotes innovation and development of new medicines by European micro-, small- and medium-sized-enterprises. However, healthcare systems are being re-oriented towards patient outcomes to allow for personalised medicine and value-based healthcare and make them sustainable in European countries with universal health coverage. Moreover, new health actors have entered the health ecosystem who need to be taken into consideration. How ensure the safety of medicines and new health products and medical devices and technologies? How could EMA adapt to this new paradigm?

Adaptation of regulatory mechanisms - economic growth

EMA is committed to enabling timely patient access to new medicines, and plays a vital role in supporting medicine development for the benefit of patients.  The Agency uses a wide range of procedures and regulatory mechanisms to achieve these aims, which are continuously reviewed and improved. The single market for health in the EU has changed, those mechanisms need to be adapted to new, upcoming actors, unceasingly stimulating the economic growth through innovative value-based health care approaches. How can EMA shift its model and focus on value and patient outcomes, introduce a new dimension into its mechanisms, and better support patient support programmes?

Conclusions
 

Moderator:
Ms Monica Dietl, Senior Advisor, Science|Business

Information
Contact

For more information on this event, please contact Lysiane Pons (lysiane.pons@sciencebusiness.net).

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