European Union

President Michel received the letters of credentials from four new ambassadors to the European Union.

Foreign Affairs Council ministers issued a statement on the crisis in Idlib and the situation at the EU external borders with Turkey.

Differences over Fidesz - Edina Tóth's, MEP for Fidesz, responds to the EUobserver op-ed from Katalin Cseh, and MEP from Hungary's Momentum ('Dear EPP, please, please expel Orban), last week.

Greek authorities expelled from the country on Friday (6 March) a group of German neo-Nazis who visited the EU’s external frontier with the aim of spreading nationalistic hatred, Greek media have reported.

The COVID-19 novel coronavirus is spreading through Europe. Apart from the health risk, it is also forcing businesses, as well as EU institutions, to cancel travel and public events and switch to teleworking, in the hope of slowing the epidemic....

Written by Gianluca Quaglio with Sophie Millar,

Drug development: heavily ‘drug-focused’ rather than ‘patient-focused’

©/Lightspring/Shutterstock.com

For a drug to be prescribed to a patient, it must first be rigorously tested for efficacy and safety and subsequently be approved by relevant authoritative bodies, such as the European Medicines Agency (EMA). However, it has been underlined that the current framework of drug development is heavily ‘drug-focused’ rather than ‘patient-focused’. This means that the end users of the drug, the patients, are not generally placed at the centre of the drug development paradigm. In other words, achieving regulatory approval is seen as the ultimate goal, eclipsing somewhat the use of a drug in its real-world setting. This is not helped by the lack of regulatory demands or incentives for gathering such real world data.

Clinical trials generally recruit a very specific set of participants with small variability, who do not ultimately fully reflect the target population to receive the novel therapy under investigation. The resulting ‘research gap’ highlights the disconnect between the pre-approval development of medicines and their post-approval use in real-world contexts (Figure 1). In Europe, most clinical research focuses primarily on drug development for regulatory approval, instead of addressing patient and public-health needs.

Figure 1 – Research gap between drug development and real world healthcare delivery ©Pot Regnier/STOA

Establishing treatment optimisation as part of personalised medicine development

A shift in drug development is emerging, with momentum towards greater recognition of precision or personalised medicine and patient-centred approaches. The Council of the European Union, while accepting that there is no common definition of the term precision (personalised) medicine, noted that this is generally understood to refer to a medical model that uses the characterisation of individuals’ phenotypes and genotypes to tailor the right therapeutic strategy for the right person at the right time and/or to determine the predisposition to disease and/or to deliver a targeted prevention strategy (Council of the EU, 2015).

A patient-focused approach, termed treatment optimisation or applied research, would bridge the gap between the first stage (regulatory approval) and the second stage (real-world application) of drug development, giving strength to the direction of personalised medicine development.

Numerous drugs are authorised on the market, with limited knowledge on how to use them for dose, sequence, combination and duration of treatment. The treatment optimisation approach could answer questions such as: whether a lower dose of the drug could produce the same results with potentially fewer toxic side effects; how the drug performs in terms of patient-relevant outcome measures such as quality of life and overall survival; and long-term use effects. There is therefore a need for investigation of the optimal way to use medicines.

Role of key stakeholders in the current drug development system

Developing a drug and bringing it into clinical practice is a complex process involving multiple partners in several areas, namely: (i) pharmaceutical industry; (ii) regulatory agencies; (iii) payers (in healthcare, this term generally refers to entities other than patients that finance or reimburse the cost of health services); (iv) Health Technology Assessment (HTA) agencies; (iv) clinicians; (v) patients; (iv) academia. Although they have a common goal (the benefit of the patient), they work with different priorities and methodology. For example, while pharmaceutical companies seek – among other things – profit, researchers want to develop their medical tools and academic career, regulators assess the therapeutic efficacy, and payers make sure that the medical innovations are worth the public investment (Figure 2).

©Pot Regnier/STOA

The presence of different actors in the drug development process does not help to narrow the research gap between the first stage and the second stage of drug development.

The STOA study

How do we move to more patient and society-centred drug development, taking all stakeholders’ perspectives and needs into account? It is about bridging the gap between two dimensions that are often misunderstood: (i) efficacy, which is demonstrated under controlled conditions in classical clinical drug trials, and (ii) effectiveness, defined as how a drug performs in the real world of widely varying patients and doctors in different types of hospitals and clinics.

To provide direction in enabling the implementation of treatment optimisation, 26 experts across 5 stakeholder groups were interviewed for a study carried out by the European Parliament Panel for the Future of Science and Technology (STOA) and entitled ‘Treatment optimisation in drug development’. The report was carried out in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC). The interviewees represented patient organisations, regulator and payer authorities, the pharmaceutical industry, health technology assessment agencies, and academic clinicians.

The majority of interviewees agreed that there are insufficient patient-centred approaches and real-world evidence, and a lack of adequate patient involvement during the design stage of clinical trials. The report highlights that both patient-centred and drug-centred approaches are needed and should indeed complement each other.

A number of important recommendations from interviewees regarding how to implement treatment optimisation strategies emerged, covering the process, funding, timing, design and setting for the conduct of studies. Interviewees either proposed that the process should be led by a consortium of all key stakeholders, or by academia and not-for-profit organisations with input from industry (e.g. drug supply). There was some agreement on funding, in that it should come from a combination of public and private sources. Setting-wise, interviewees either did not have a strong preference (case-by-case basis), or suggested that it should take place at a national level with possible international oversight.

In regard to the design of treatment optimisation methods, the following key features emerged from the interviews: fewer inclusion and exclusion criteria; standard of care or best available treatment as comparators; use of patient-relevant outcome measures; and publication of all results. No clear consensus was reached on blinding (whether participants or study staff should know what treatment is being followed) or randomisation.

Policy options arising from this study centred on when in the drug development ‘pipeline’ the treatment optimisation process should take place, and by which legal mechanism. Three main policy options emerged. Briefly, these were: (i) making the conduct of treatment optimisation studies part of the requirements that manufacturers have to satisfy in order to obtain marketing authorisation for their products; (ii) including treatment optimisation studies as part of the post-authorisation commitments; and (iii) conditional reimbursement mechanisms employed to compel the manufacturers to carry out treatment optimisation studies.

Whatever policy approach prevails, it is clear that significant political effort will be needed for the current legislative frameworks to be modified, at both European and national level.

While the European Commission has just presented its Gender Equality Strategy, European Commission Vice-President for Values and Transparency Věra Jourová insisted in an interview with EURACTIV France that the fight against stereotypes and violence against women must continue.

Italy, affected by the coronavirus more than any other EU country, has been requesting since last week other member states’ assistance in providing personal protective equipment such as masks. However, just one member state responded to the request, EURACTIV was informed.

Closing the European Parliament due to coronavirus is not currently being considered – but given the rising health concerns, this is something that should be put on the table, and sooner rather than later.

Formula One championship-winning team Mercedes has announced this week that it aims to become carbon-neutral by the end of 2020, as the glitzy motorsport continues its drive to go green.

By refusing to respond to questions on human rights, the European Commission has given the far-right a carte blanche on asylum and migration.

Plenary session, Brussels

Source : © European Union, 2020 - EP

Campaigners have urged European governments and the UK to clarify their 'confused' policies to guide UK citizens living in the EU through the post-Brexit “no man’s land”, following the publication of two new reports on Friday (6 March).

The EU is willing to provide more money for migrants stranded in Turkey, but Ankara must refrain from using them as a bargaining chip, the bloc's foreign ministers announced after an extraordinary meeting about the crisis in Syria's northwestern Idlib province, held in Zagreb on Friday (6 March).

Written by Marketa Pape,

© MNBB Studio / Shutterstock.com

Transport is a strategic sector of the EU economy. Essential to ensuring free movement, it enables people and goods to overcome distances, borders and natural barriers, directly affecting the everyday lives of all EU citizens. Maintaining the flow of goods from producers and manufacturers to consumers makes efficient transport systems a backbone of European integration. For the single market to function well in all regions, the EU needs sustainable, efficient and fully interconnected transport networks.

As the demand for transport services grows, reducing transport emissions and negative impacts on human health and the environment has become one of the main challenges. New technologies, such as digitalisation, and connected and automated mobility, open new possibilities to improve transport safety, security and efficiency, and to reduce emissions, but also transform the employment in the sector in terms of working conditions and required skills. Collaborative economy developments, such as car-sharing and bike-sharing services are changing user behaviour and mobility patterns. EU transport policy needs to help the sector cut emissions drastically by running on less and cleaner energy, utilise modern infrastructure, and reduce its impact on the environment.

The new President of the European Commission, Ursula von der Leyen, has put transport on a fast track towards becoming decarbonised and digital. This transformation is to be a key part of her European Green Deal and ‘making Europe fit for the digital age’ priorities. In 2020, the Commission will propose a ‘climate law’, committing the EU to becoming climate neutral by 2050. The European Council has endorsed this objective and Parliament had already called for ambitious goals and a corresponding long-term EU budget. While concrete steps towards this ambitious goal remain to be defined, it will require a step change to make transport modern, sustainable and decarbonised.

Read the complete Briefing on ‘EU policies – Delivering for citizens: Transport policy ‘ on the Think Tank pages of the European Parliament.

Listen to policy podcast ‘Transport policy‘ on YouTube.

The European Defence Agency (EDA) confirms that two additional staff members have tested positive for COVID-19. Both staff members have been at home in self-isolation since 2 March and have thus not returned to the Agency since symptoms appeared.

Given that both staff members had been in close contact with the first staff member who has tested positive, the Agency, while awaiting test results, has proactively taken additional precautionary measures to those already outlined in its statement of 4 March.

The additional precautionary measures include: 

• EDA has personally informed all individuals who were in close contact with the two colleagues four days prior to the appearance of symptoms;
• EDA has asked its staff members in close contact to self-isolate themselves for 14 days as a precaution.

All three EDA staff members who have tested positive for COVID-19 are at home and have not reported any adverse change in their health.

EDA will continue to closely monitor the situation and remain in close contact with the responsible health authorities (Belgian health authorities as the host nation, the European Centre for Disease Prevention and Control (ECDC), the EU Inter-Institutional Medical Board and the World Health Organisation) in order to strictly follow their guidance.

 

The Council today adopted conclusions on air quality which give political guidance for further work to combat air pollution.

The EU is complying with the pledges made in the Paris Agreement. Today, the Council adopted the submission of the EU's mid-century, long-term objective to the United Nations

In his opening speech at the Centre for European Policy Studies - Ideas Lab 2020, President Michel outlined his vision for the single currency and how the euro could play a more prominent role internationally.

The Council extended the asset freezes directed against certain persons responsible for the misappropriation of Ukrainian State funds until 6 March 2021.