Revision of Pharmaceutical Legislation event: The need for pragmatism - Register now!

Welcome, health colleagues, to the European Alliance for Personalised Medicine (EAPM) update – as we approach the end of February, EAPM is heralding a series of multi stakeholder roundtables focused on EU Regulatory policy that will take place during March, writes EAPM Executive Director Dr. Denis Horgan.

Roundtables, Consensus Panels 
Initially, there will be a roundtable on Liquid Biopsies in the context of the EU Beating Cancer Plan implementation on 9-10 March, followed by a consensus panel on Impact of the Application of the In-Vitro Diagnostics Regulation on 11 March and a conference on the Revision of Pharmaceutical Legislation on 15 March. This latter pharmaceutical event is particularly important, and registration is already open, click here to see the agenda and to register click here. 

More on the Pharmaceutical Legislation event
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? 

With the upcoming revision of EU pharmaceuticals legislation, and drawing lessons from the COVID-19 pandemic, EAPM is organising a series of consensus panels regarding this topic on 15 March, with attendees 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, MEPs, patient organizations, and umbrella organizations representing interest groups and associations actively engaged in the field.

Session are as follows: 

• 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

As mentioned, Registration is open, to see the agenda click here and to register, click here. 

More efficient cancer care
Parliament has adopted its final recommendations for a comprehensive and co-ordinated EU strategy to fight cancer. The report by Parliament’s Special Committee on Beating Cancer (BECA) was adopted with 652 votes in favour, 15 against and 27 abstentions.

Focus on cancer prevention:  As more than 40% of all cancers are preventable through “co-ordinated actions targeting behaviour-related, biological, environmental, work-related, socio-economic and commercial” risk factors, MEPs called for effective prevention measures at national and EU level, based on independent scientific expertise. 

Recommended measures include funding programmes that encourage people to stop smoking and promoting actions to reduce and prevent alcohol-related harm as part of a revised EU alcohol strategy. 

A key issue that EAPM is championing relates to lung cancer screening as well as the uptake of advanced molecular diagnostics linked to public health genomics.

Digital health data 
The Commission’s upcoming European Health Data Space (EHDS) — expected in April — is set to be an interesting addition to its fast updating digital rulebook: The Data Act slots into an already ambitious digital policy framework with the goal of bringing clarity and fairness around the sharing of (mostly industrial) data generated by connected devices. 

It won’t be the last word on this either, as the Commission is working on sector-specific regulations to plug into the Data Act (including one incoming within “weeks” for health data-sharing; and another in the works for connected cars). But EU lawmakers said today that they intend the Data Act to be around for the long term. “We wanted to make sure this was a horizontal text because it has to be a long term one, it has to be visible, it has to be clear in the long term,” noted Internal Market Commissioner Thierry Breton, during a press conference.

Former DG SANTE chief on Commission whys and wherefores
Anne Bucher was director general of DG SANTE until she retired from the Commission at the end of 2020. Now she’s writing about what her old employer is up to - like in other areas of the EU, the crisis has been instrumental in catalyzing action, said Bucher. She pointed to the creation of the European Health Emergency preparedness and Response Authority (HERA) as well as the joint purchase of vaccines as the biggest consequences of the pandemic 

On HERA, she said: “I’m surprised at how much the Commission has managed to get off the ground. The HERA incubator has already delivered results. And the fact that a budget could be found after the [EU’s multi-annual budget] was agreed was a sign of a big commitment.” 

And, on pharma reform: “The pandemic has also underscored the importance of an orderly pharmaceutical market. Problems with medicines shortages, as well as the inequalities in access to innovative drugs, were already high on the ministers’ agenda before the pandemic. But the coronavirus is the topic of a well-functioning marketplace that rewards innovation while ensuring resilience and access even more important.” 

Cross-Border Healthcare Directive 
The directive, introduced in 2011, was designed to allow patients to access treatment anywhere in the EU. That could mean a patient in Belgium might opt for a hip replacement in France because waiting lists there are shorter, for example.

But in practice, few patients are using the option due to numerous hurdles.

For example, most EU countries have implemented an approach that requires prior authorization from their national health care provider or insurer, but this was not mandatory in the directive. EU citizens have the right to access healthcare in any EU country and to be reimbursed for care abroad by their home country. There is also a lack of information for patients on how to get prior authorization. 

This in large part comes down to failings among so-called national contact points (NCPs), which are designated enablers for patients seeking cross-border health care. The directive states that NCPs should be engaging with patient groups, health care providers and insurers to keep everyone up to speed on the rules. This isn’t happening in some countries, however, leaving patients in an information vacuum. 

Cancer care in Africa 
While progress in oncology has been remarkable in recent decades, not every cancer patient is benefitting from the advances made in treating their disease. The contrast in diagnosis, treatment and its outcome between high-resource and low-resource countries is dramatic. Africa presents an enormous challenge with population growth and life expectancy increasing in many countries as the toll of AIDS and other communicable diseases declines. 

However, there has been little investment in capacity of any sort to deal with the current cancer problem, never mind the rapid increase in incidence which is underway. This is a critical area for investment and not only of a purely financial nature. It is bad to have cancer and worse to have cancer if you are poor. 

The gap between rich and poor, highly educated and less educated and the North–South divide is substantial and continuing to grow. Radical solutions are urgently needed: the status quo is not an appropriate response to the current situation. Recognising that no single government or source of philanthropy has the means to solve this problem, new models are needed to cope with and improve this situation.

French presidency aims to ‘strengthen’ digital sovereignty in AI Act 
The French presidency circulated a new partial compromise on the AI Act – the partial compromise text for Art. 16-29 of the AI Act was circulated in the EU Council. The changes include more substantial obligations for high-risk AI system providers, notably for transparency, tracing, documentation and cooperation with users. At the same time, the exemption for credit institutions was weakened. 

The new measures also clarify the obligations for third-party service providers and how the liability would be attributed across the value chain. Additional responsibility for the authorised representatives of non-EU providers has also been introduced, making them jointly liable for defective systems. The compromise text also clarifies importers and distributors’ obligations and adds an obligation for qualified human oversight on the users.

And that is everything from EAPM for this week – remember to click here to see the agenda  and to register here for the EAPM pharmaceutical legislation event on 15 March, stay safe and well and enjoy your weekend.

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