Pragmatism in pharmaceutical legislation: Screening for the biggest killers

Welcome, health colleagues, to the European Alliance for Personalised Medicine (EAPM) update – EAPM is busy at the moment preparing for its upcoming Pharmaceutical Legislation event on 15 March as well as internal events on the liquid biopsies as well as on the implementation of the IVDR legislation at the country level, writes EAPM Executive Director Dr. Denis Horgan.

A respectful pause

To begin, EAPM’s thoughts are very much with all the civilians who are suffering due to Russia’s invasion of Ukraine – let us hope that calmer minds will prevail.

Pharmaceutical Legislation: The need for pragmatism – and how to make it happen

EAPM is organizing a series of consensus panels regarding the topic of pharmaceutical legislation on 15 March - the dramatic improvement in the health of the citizens of Europe over the past two centuries has transformed the continent and the lives of the people living in it. But is Europe able to seize the new benefits that science, technology and forward-thinking public-policy decisions could confer on current and future generations of Europeans – or is it losing the will and capacity to grasp the fruits of progress?   To view the agenda click here and to register, click here. 

Sessions will include: 

• Consensus Panel I: Familiar challenges and new complications
• Consensus Panel II: Market Authorization, Access & Incentives 
• Consensus Panel III: Predictable and sustainable access to quality medicines 
• Consensus Panel IV: Unmet medical need 
• Consensus Panel V: Formalize existing pathways for innovative medicines & Ensure expedited assessment pathway
• Consensus Panel VI: Shortages of medicines and vulnerabilities in the pharmaceutical supply chain

Despite us not being able to meet face-to-face, events such as this still allow the pulling together of leading experts in the arena of personalised medicine drawn from patient groups, payers, health-care professionals plus industry, science, academic and research representatives.

A key role of the conference is to bring together experts to agree policies by consensus and take our conclusions to policymakers. And this time, we go even further into the realm of expertise, given the huge crisis that we are all facing.

Attendees will be drawn from key stakeholders whose interaction will create a cross-sectoral, highly relevant and dynamic discussion forum. These participants will include public health decision makers, representatives from the European Commission, Members of the Parliament, patient organisations, and umbrella organisations representing interest groups and associations actively engaged in the field. Each session will comprise panel discussions as well. To view the agenda click here and to register, click here. 

EU health care resilience

The French Presidency hosted a conference on Thursday (3 March) focused on strengthening the bloc’s health care industry’s resilience and strategic autonomy. The pandemic highlighted the EU’s vulnerability, with shortages and tensions on supply chains, The health workforce is a key component of any health system and the present crisis offers a unique opportunity to better understand its specific contribution to health system resilience. The literature acknowledges the importance of the health workforce, but there is little systematic knowledge about how the health workforce matters across different countries. 

Who signed on: A total of 16 member states are in support of the health Important Projects of Common European Interest (IPCEI): Austria, Belgium, Denmark, France, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Poland, Romania, Slovenia and Spain.

Digital Markets Act

The European Commission has published its proposal for a Data Act, the second building block of its data strategy. The first step was the Data Governance Act, legislation adopted at the end of last year that provides a legal framework for sharing non-personal data. The Data Act is meant to go one step forward, introducing binding requirements for the manufacturer of connected devices and related services to provide access to the data that users create. 

"We want to give consumers and companies even more control over what can be done with their data, clarifying who can access data and on what terms," said Margrethe Vestager, the Commission's executive vice president responsible for the digital portfolio. Data-sharing obligations The overall principle of the Data Act is that business users and consumers should be able to access, manage and share the data they contribute to creating when using a connected device or a respective service such as virtual assistants. 

Therefore, the providers of these services, defined as data holders, should create by default an interface where users can easily access and manage their data at no extra cost. The users might decide to share that data with a third party, although the data holder might at the same time protect trade secrets and other confidential information.

EU proposes to allow more sustainability cooperation, data sharing

The European Commission has launched a public consultation inviting all interested parties to comment on two draft revised Horizontal Block Exemption Regulations on Research & Development (‘R&D') and Specialisation agreements (‘R&D BER' and ‘Specialisation BER' respectively, together ‘HBERs') and the draft revised Horizontal Guidelines. The draft revised HBERs and Horizontal Guidelines follow a review and evaluation process launched in September 2019.  

As set out in more detail in the explanatory note accompanying the draft revised HBERs and Horizontal Guidelines, the proposed changes aim to (a) make it easier for companies to co-operate in areas such as R&D and production, (b) ensure a continued effective protection of competition, (c) include a new chapter on the assessment of horizontal agreements pursuing sustainability objectives as well as new guidance on data sharing, mobile infrastructure sharing agreements and bidding consortia and (d) simplify the administrative supervision by the European Commission and National Competition Authorities by streamlining and updating the general framework of assessment of horizontal cooperation agreements. 

Expand screening to lung and prostate cancer, say EU experts

The EU’s Group of Chief Scientific Advisers (GCSA) has issued scientific advice to the Commission to strengthen its plan to fight cancer in Europe. The priority, they say, is to extend screening to other different kinds of cancer.  The GCSA comprises seven scientists who provide independent recommendations to improve the exchange between policy-making and scientific advice at the European level.    

EAPM contributed to this panel.

In their new opinion released on Wednesday (2 March), GCSA scientists issued a series of recommendations for combating cancer in Europe, highlighting the need to improve existing screening programmes for breast, colorectal and cervical cancer.  “The advice of the Chief Scientific Advisors will support our update of guidelines for cancer screening in the EU with the most up-to-date scientific knowledge, delivering the best possible outcomes for all Europeans,” said Stella Kyriakides, DG HEALTH at the Commission in an online press release.  

Most importantly, the scientists advocate extending screening programmes to lung and prostate cancer while also making them more accessible to increase the participation rate of European citizens.  According to scientists, cancer is usually diagnosed in patients who already have symptoms, or it is discovered during medical tests for other diseases.  “Population-based screenings are major tools to help detect cancer early, which in turn gives the best chances of survival,” said Professor Eva Kondorosi, one of the members of the GCSA. According to the World Health Organisation (WHO), in Europe, lung, breast, stomach, liver and colon cancers cause the most deaths each year. WHO recommends working on early detection through early diagnosis and screening programmes for breast and cervical cancer. 

 “Participation to existing screening programmes for breast, cervical and colorectal cancer should be improved, also considering individual risk factors and with the help of emerging technologies,” Kondorosi said, adding that screening programmes should be extended to include lung and prostate cancer as well.  By 2035, cancer could become the leading cause of death in Europe, but it could be avoided in 40% of cases through better prevention and screening, said BECA rapporteur Véronique Trillet-Lenoir (Renew).

And that is everything from EAPM for this week – stay safe and well, enjoy your weekend, and once more, for our event on 15 March on the Pharmaceutical Strategy, to view the agenda click here and to register, click here. 

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