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#HTA debate ongoing: Amendments to be decided, compromises to be agreed

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The issue of the European Commission’s proposals on more EU-wide cooperation in health technology assessment, or HTA, has been discussed in the European Parliament on several occasions, and has seen continuous engagement on the topic between the European Alliance for Personalised Medicine and MEPs,
writes European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan.

Indeed, EAPM will host a meeting in Brussels on 26 September to discuss in detail upcoming amendments and compromises to the proposal.

The background is that at the start of this year the Commission put forward its proposal for joint clinical assessment (JCA) in respect of HTA.

The proposed Regulation covers new medicines and certain new medical devices, providing the basis for permanent and sustainable co-operation at the EU level for joint clinical assessments in these areas. The plan is that member states will be able to use common HTA tools, methodologies and procedures across the EU.

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The Commission has stated that the diversity and multitude of approaches to HTA across the Member States means that, due to their scale and effect, only action at Union level can eliminate obstacles. Without such action, it argues, it is unlikely that national rules on how HTAs are carried out would be harmonized.

In the past, the WHO has said that HTA should be an instrument used to support access to health for everyone.

On the face of it, this all sounds more than reasonable. But ensuing events have cast doubt on mandatory aspects of the plans with several member states (notably France and Germany) complaining that the Commission is over-stepping its remit, given that health is a member state competence.

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The Commission says that the proposal is aimed at improving the functioning of the internal market by harmonizing the member states' rules on carrying out clinical assessments for health technologies at national level, and at establishing a framework for mandatory joint clinical assessment at European Union level.

The Commission’s original proposal has a strong focus on overcoming impeded and distorted market access, with the institutions aiming to reach agreement by December 2018, and the European Parliament scheduled to adopt its position prior to that in October.

EAPM is strongly of the opinion that what is necessary here is improved co-ordination on EU-wide HTA, within a clearly defined framework, which may be difficult to achieve without some kind of mandatory element. What that would be remains a moot point.

Under the European Union’s social pillar each citizen across all member states should be able to have the same access to the best healthcare, often through earlier diagnosis. This is evidently not the case at the moment.

The Alliance believes that a truly constructive framework for JCA between individual HTA bodies is clearly required to cut down on unnecessary duplication. Striking a balance between a mandatory JCA and a voluntary one looks to be the only option at this stage, and it is up to the health council and its members to solve this issue.

Currently there are delays in HTA decisions which inevitably lead to unacceptable delays in access. The key to the Commission proposal is ensuring that member states pool their expertise with the help of a facilitating framework and mechanism.

Parliament’s ENVI committee, under rapporteur Soledad Cabezón Ruiz MEP, has been regularly discussing the best possible amendments to the proposed legislation.

Cabezón Ruiz has already stated that the Commission’s initiative could strengthen the EU, despite the aforementioned resistance in certain member states, saying that the EU needs more and better clinical evidence. This would help to determine the efficacy and therapeutic benefits of medicines.

Meanwhile, growing difficulties about patient access have been highlighted in ENVI meetings, as well as at roundtables involving EAPM.

The committee rapporteur Cabezón Ruiz and others have also called for medical devices to be included in any new legislation, while industry has strongly said that it wants them left out.

As a topic of considerable concern to citizens, their health needs to be protected and as part of this the assessment of clinical health technologies is of vital importance, MEPs have said.

The rapporteur has added that research should be prioritised, and that the Commission proposals could help this process, which would be implemented by independent experts coming from national HTA institutes.

Another MEP, Bolesław G Piecha has previously noted that the HTA topic is a top priority and that the cooperation framework should be supported by means of common tests based on common principles. He has, however, pointed out that there are some issues on the inclusion of high-risk medical devices in the scope of the proposal.

Gesine Meissner MEP is also on record as suggesting that putting medicine and medical devices together under the proposals could be very complex.

Several ENVI members have cited the need for independence of assessments, but added that a network needs to be formalized regarding voluntary cooperation. Also, there needs to be stronger dialogue between the EMA and the HTAs.

In the face of the ongoing debate, the Commission has pointed out that the EU is not starting from zero, as there has been a degree of co-operation on HTA for 20 years. Yet the Commission is determined to step up commitments in this area.

Compromises appear inevitable, and EAPM will be involved as much as possible.

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Belgium

Clashes break out in Brussels in protests over coronavirus restrictions

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Police and protesters clashed in the streets of Brussels on Sunday (21 November) in demonstrations over government-imposed COVID-19 restrictions, with police firing water cannon and tear gas at demonstrators throwing rocks and smoke bombs, witnesses said, write Christian Levaux, Johnny Cotton and Sabine Siebold, Reuters.

About 35,000 people took part in demonstrations, police said, which began peacefully before violence broke out.

Protesters wearing black hoods threw stones at police as they advanced with water cannon at the main junction in front of the European Union Commission headquarters, Reuters journalists said.

Facing up to the police lines, the protesters held hands and chanted "freedom". One protester was carrying a placard reading "when tyranny becomes law, rebellion becomes duty".

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Police forces stand guard as people protest against coronavirus disease (COVID-19) measures near the European Commission in Brussels, Belgium November 21, 2021. REUTERS/Johanna Geron

Protesters also threw smoke bombs and fireworks, the newspaper Le Soir reported. The situation calmed down later, police said.

Belgium tightened its coronavirus restrictions on Wednesday (17 November), mandating wider use of masks and enforcing work from home, as cases rose in the country's fourth COVID-19 wave. Read more.

There have been 1,581,500 infections and 26,568 coronavirus-related deaths reported in the country of 11.7 million people since the pandemic began. Infections are increasing again, with 13,826 new cases reported on average each day.

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Violence has also broken out in anti-restriction protests in Belgium's neighbour the Netherlands in recent days. On Friday, police in Rotterdam opened fire on a crowd.

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European Commission

NextGenerationEU: Commission receives payment request from Spain for €10 billion under the Recovery and Resilience Facility

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The Commission has received the first payment request from Spain under the Recovery and Resilience Facility (RRF) for a disbursement of €10 billion in financial support (net of pre-financing). Spain's overall recovery and resilience plan will be financed by €69.5 billion in grants. Payments under the RRF are performance-based and contingent on Spain implementing the investments and reforms outlined in its recovery and resilience plan. This first payment request relates to 52 milestones covering several reforms in the areas of sustainable mobility, energy efficiency, decarbonisation, connectivity, public administration, skills, education and social, labour and fiscal policy.

The Commission now has two months to assess the request. It will then send its preliminary assessment of Spain's fulfilment of the milestones and targets required for this payment to the Council's Economic and Financial Committee. More information on the process of the payment requests under the RRF is available in this Q&A. More information on the Spanish recovery and resilience plan is available here.

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Belgium

'When the Smurfs meet Monkey King'

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'When the Smurfs meet Monkey King' is a children's art exhibition celebrating the 50th anniversary of the establishment of diplomatic relations between China and Belgium.

The successful art exhibition celebrating the 50th anniversary of the establishment of diplomatic relations between China and Belgium in La Louvière, the birthplace of Surrealism in Belgium that ended on 24 October gave the opportunity to nearly 300 local primary and middle school students in just one week to depict their vision of friendship between China and Belgium.

On 17 October, during the opening ceremony, Françoise Ghiot, Laurent Wimlot, aldermen of La Louvière, and their guests from China and Belgium attended the event. Counsellor Yang Qing, wife of the Chinese Ambassador to Belgium, also recorded a video for the inauguration of the event.

Counsellor Yang Qing said in her speech that she admired the exhibition held in La Louvière. Using pure and innocent artistic perspective, extraordinary creativity and imagination, the children have well defined the cultural elements of both countries. Celebrating the 50th anniversary of the establishment of diplomatic relations between China and Belgium with children’s eyes, sincere feelings, those future ambassadors of friendship have expressed their visions of a better collaborative future between the two nations.

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Ghiot said in her speech that she was very happy on the occasion of the 50th anniversary of the establishment of diplomatic relations between China and Belgium to see children’s paintings from China. The art exhibition opened a skylight of artistic exchange for local children.

This children's art exhibition was jointly curated by the city of La Louvière, the Nardone Gallery, and Yellow Vitamines. Through the LPGA (Little Painter Global International Art Exhibition), covering 40 cities and 500 aesthetic education training institutions in China, 5000 children’s work were collected and 200 were finally selected to focus on Belgium. With the innocent help of children's brushes, imagination and understanding, art and culture provided an ideal medium to understanding differences and strengthening the bond between China and Belgium.

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