HTA alignment of the stars, EMA deals on the cards and EU Presidency event on the horizon

Good morning and welcome, health colleagues, to the European Alliance for Personalised Medicine (EAPM) update – we’re still looking forward to and giving a big push to our the upcoming EAPM Slovenian EU Presidency conference, so here’s another quick reminder that registration is open, and the conference takes place in little over a week on Thursday 1 July, writes EAPM Executive Director Dr. Denis Horgan. 

Bridging Conference: Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care Systems – Registration Open

The EAPM conference will act as a bridging event between the EU Presidencies of Portugal and Slovenia. AThe conference is divided into five sessions which cover the follows areas:  

• Session 1: Generating alignment in the regulation of Personalized Medicine: RWE and Citizen Trust
• Session 2: Beating Prostate Cancer and Lung Cancer - The Role of the EU Beating Cancer: Updating EU Council Conclusions on Screening
• Session 3: Health Literacy - Understanding Ownership and Privacy of Genetic Data
• Session 4: Securing patient Access to Advanced Molecular Diagnostics 

Each session will comprise panel discussions as well as Q&A sessions to allow the best possible involvement of all participants, so now is the time to register here, and download your agenda here.

Health Technology Assessment: Informal deal between Council and European Parliament 

The EU has taken a major step towards new rules which will benefit patients' access to medicinal products and medical devices and simplify the submission procedure for producers of such health technologies. The Council and the European Parliament today struck a political deal on a legislative proposal concerning joint work on health technology assessment. 

Portuguese Heath Minister Marta Temido said: We have reached a decisive breakthrough on a new law which will benefit patients, manufacturers of health technologies and member states' health systems. We will all stand to gain when innovative, safe and effective health technologies can reach the market more quickly. EU-level cooperation is the way forward to make this happen.” 

The new rules foresee the co-operation of member states at EU level on joint clinical assessments and joint scientific consultations on health technologies. This joint work will provide valuable scientific information to national health authorities when they take decisions about pricing and reimbursement of a health technology. According to the agreed text, in order to reduce the administrative burden especially for smaller companies, developers of health technologies should only have to submit information, data and other evidence required for the joint clinical assessment once at EU-level. 

The Parliament’s lead rapporteur, Tiemo Wölken, claimed a victory in fighting for stronger provisions for using the joint clinical assessments, so “that joint assessments cannot be ignored”, and shortening the implementation period. “Especially now, faced with a health crisis, it is increasingly important that we, as a Union, pool our expertise and resources to ensure good quality joint assessments whilst contributing to timely access of innovative health technologies,” Wölken said.

The presidency will submit the outcome of the negotiations to the Council’s Permanent Representatives Committee (Coreper) for endorsement. This will be followed by adoption by the Council and then the European Parliament. The new rules will become directly applicable, in a staged process, three years from the entry into force of the regulation.

Extension of the mandate of the European Medicines Agency (EMA) 

The European Commission has adopted a legislative proposal to extend the mandate of the European Medicines Agency (EMA). The initiative is among the first steps towards building the European health union announced by President Ursula von der Leyen in her State of the Union address. 

The proposals put forward aim to strengthen the EU's health security framework, and to reinforce the crisis preparedness and response role of key EU agencies. As the Commission points out, the EMA and the European Centre for Disease Prevention and Control (ECDC) have been at the forefront of the EU's work to address the coronavirus pandemic. 

However, COVID-19 has shown that both agencies need to be reinforced and equipped with stronger mandates to better protect EU citizens and address cross-border health threats. 

According to the Commission, the EMA's mandate will be reinforced so that it can facilitate a co-ordinated EU-level response to health crises by: Monitoring and mitigating the risk of shortages of critical medicines and medical devices; providing scientific advice on medicines that may have the potential to treat, prevent or diagnose the diseases causing those crises; coordinating studies to monitor the effectiveness and safety of vaccines, and;  coordinating clinical trials.

Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) is responsible for the file. Plenary adoption of the negotiating mandate is set for July - one of the main objectives of the new draft EMA rules is to better enable it to monitor and mitigate potential and actual shortages of medicines and medical devices that are considered critical to respond to public health emergencies such as the COVID-19 pandemic, which revealed shortcomings in this regard. 

MEP amendments to health committee report on Pharma Strategy 

The European Parliament rapporteur on the new EU pharmaceutical strategy is pushing for companies to be forced to invest more of their profits in R&D. “We have to look at the profits that these big companies are making and are not reinvesting in research and development, but are paying shareholder dividends, or buying stocks and shares, so that their value goes up in the stock exchange,” said Belgian MEP Marc Botenga, who is leading a report by the ITRE committee on the pharmaceutical strategy for Europe. 

The pharmaceutical strategy presented back in November aims to boost drug discovery, development and manufacturing inside the bloc, including new antibiotics and treatments for rare diseases. The plan is also meant to end shortages of medical supplies, as seen in the first few weeks of the COVID-19 crisis when the EU scrambled to purchase drugs and equipment from abroad. 

MEPs want to see pharmaceutical companies invest more in discovery and development of drugs for small patient populations, which are of limited commercial appeal. Proponents of this, claim the industry is producing fewer novel drugs than it did in the 1950s. “We give a lot of money to research and development, but too few medicines being produced and they often don't respond to the urgent needs of society and public health,” said Botenga.

Human trials begin for cancer vaccines

There are two types of vaccines that can prevent cancer approved by the US Food and Drug Administration (FDA): HPV vaccine. The vaccine protects against the human papillomavirus (HPV). There are vaccines that treat existing cancer, called treatment vaccines or therapeutic vaccines. 

These vaccines are a type of cancer treatment called immunotherapy. Antigens, found on the surface of cells, are substances the body thinks are harmful. The immune system attacks the antigens and, in most cases, gets rid of them. 

This leaves the immune system with a "memory" that helps it fight those antigens in the future. Cancer treatment vaccines boost the immune system's ability to find and destroy antigens. Often, cancer cells have certain molecules called cancer-specific antigens on their surface that healthy cells do not have. When a vaccine gives these molecules to a person, the molecules act as antigens. They tell the immune system to find and destroy cancer cells that have these molecules on their surface.

UK data protection ‘adequacy’ gets EU governments’ sign-off 

EU governments have approved plans to recognise UK data protection standards as aligned to those that apply in the EU, according to reports. The decision paves the way for personal data to be transferred freely from the EU to the UK and will be welcomed by multinational companies. 

Prior to Brexit, the UK was automatically considered as being aligned to EU data protection standards, but the EU deemed that a fresh assessment was required after the Brexit transition period ended. Transitional arrangements were agreed alongside the EU-UK Trade and Cooperation Agreement reached in late 2020 to allow personal data to continue to flow freely from EU member states to the UK in the short-term, but there had been uncertainty over the longer-term position. However, in February, the European Commission issued draft ‘adequacy decisions’ with a view to facilitating the continued free flow of personal data from the EU to the UK. 

That is all from EAPM for now – have an excellent week, stay safe and well, and don’t forget to register for the EAPM Slovenian EU Presidency conference on 1 July here, and download your agenda here!

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