Towards better pharmaceutical provision in Europe - Who decides the future?

Greetings, and welcome to the European Alliance for Personalised Medicine (EAPM) update, writes EAPM Executive Director Dr. Denis Horgan.

Lawmakers press Commission to make pharma strategy more pro-business

On this topic, EAPM has published an academic article, Towards Better Pharmaceutical Provision in Europe — Who Decides the Future? which can be read here.

The European Commission needs to ensure that its planned revamp of the EU’s pharmaceutical rules don’t end up undermining the industry at which it is aimed, a group of European and national lawmakers wrote in a letter to the executive.

The strikingly pro-business initiative was spearheaded by Romanian MEP Cristian Bușoi, chairman of the European Parliament’s industry committee (ITRE), and was signed by 34 other European and national lawmakers.

“We note with concern the focus of some actors to clamp down on the role of the pharmaceutical industry, regardless of the impact it has on the development of medicines, and our autonomy as a Union of member states to determine our future research agenda, while in global competition with, for example, the US and China,” reads the letter, which was sent on Wednesday evening (5 October).

It suggests three priorities for the Commission: It calls for flexibility from regulators to create a “highly competitive” pharmaceutical research environment, as well as for more access to health data for companies. Strategic autonomy is another priority, with the letter suggesting that it could be bolstered by encouraging new medicines development through “strengthening incentives.”

Finally, it says that while the Commission should tackle “inequalities and delays in access to medicines,” this should not be done with “disproportionate obligations.” It specifically takes aim at any proposals that would tie incentives to whether or not a product has been launched on European markets. This echoes objections already aired by pharmaceutical industry group EFPIA, which has also publicly opposed efforts to link market access and incentives.

Regarding the academic article mentioned above, a key message from the paper is that better understanding of the consequences of policy decisions or therapeutic choices could permit significant improvements. Development of databases on resource use and outcomes would allow comparative studies of efficiency in different countries/regions/populations. Studies could reveal to what extent countries spend on cost-effective medicines—on which there is currently little evidence, because it is not investigated. Similarly, there is little information on waste in health care spending—and the lack of information means there are few incentives for reducing it. New options for prevention, diagnosis, and treatment are useful only if there are also data on how they should be implemented in the health care system. The new evidence landscape offers more alternatives and more choices, and creates an increased need for evaluation. 

Please click here to read the article.

MEPs endorse expansion of ECDC mandate and cross-border health threats regulation

Over two years into the coronavirus pandemic, members of the European Parliament have voted overwhelmingly in favor of the last two building blocks of the Health Union package.

Lawmakers adopted the cross-border health threats regulation with 544 MEPs voting in favor of the deal reached with the Council, 50 voting against and 10 abstentions.

On extending the mandate of the European Centre for Disease Prevention and Control (ECDC), 542 MEPs voted in favor, 43 voted against and 9 abstained.

“The extended ECDC mandate is a significant step towards a safer, better prepared and more resilient Europe,” said ECDC director Andrea Ammon. “I look forward to strengthened cooperation and action with the European Commission and other EU bodies, national authorities and international partners to respond collectively to threats posed by infectious diseases, and to ensure that we continue improving the lives of people in Europe and globally.”

“This legislation clearly responds to the 74 [percent] of European citizens who want greater European involvement in crisis management,” said MEP Véronique Trillet-Lenoir, of the Renew Europe group, the rapporteur for the cross-border health threats file. “The European Health Union is being built step by step. We will continue this project in the context of discussions on a future convention on the revision of the European treaties,” she said.

The texts will now have to be formally endorsed by Council to take effect.

Health Union votes

Members of the European Parliament voted overwhelmingly in favour of the last two building blocks of the Health Union package on Tuesday: the cross-border health threats regulation and the expansion of the European Centre for Disease Prevention and Control’s 

mandate.  Trifecta: The bundle of initiatives to bolster the EU’s health powers came in response to the coronavirus pandemic, with the Commission announcing the proposals in November 2020. 

In addition to the two pieces of legislation adopted on Tuesday, it also includes the expansion of the European Medicines Agency’s remit, which was endorsed by the Parliament in January and applied as of March. MEP Peter Liese, the EPP’s health spokesperson, said on Monday (3 October): “I think Joe Biden is pretty close to a realistic assessment of the situation,” in stating that the pandemic was over, but adding that we still have a problem with COVID. He pointed to Europe being in a much better situation today than over the last two years, thanks to vaccines, adding: “If we look at China, we see that the problem is not over there. So Europe didn’t do that badly.” 

Transatlantic data flows

US President Joe Biden is expected to sign a long-awaited executive order on transatlantic data flows today, paving the way for a new framework that will let companies shuttle everything from family photos to payroll information from the US to the EU. The new framework, announced in March this year, seeks to address privacy concerns that the EU's Court of Justice cited in 2020 when it invalidated an earlier protocol, the Privacy Shield Framework. Legal experts expect privacy activists to challenge the new agreement, as they successfully did with the Privacy Shield and an earlier framework.

NHS set to boost GP workforce ahead of winter

Thousands more staff will be recruited to new roles in General Practice, so family doctors’ time can be freed up to see more patients during winter, the NHS has announced.

More than one thousand GP assistants will be recruited to practices from this month to offer more admin support with the roles already proven to reduce the time GPs spend on tasks such as writing letters by more than two-fifths.

GP assistants will be trained to do blood pressure checks, heart rate and blood tests as well as arranging appointments, referrals and follow-up care for patients.

A European Care Strategy for caregivers and care receivers

The European Commission has presented the European Care Strategy to ensure quality, affordable and accessible care services across the European Union and improve the situation for both care receivers and the people caring for them, professionally or informally. The Strategy is accompanied by two Recommendations for member states on the revision of the Barcelona targets on early childhood education and care, and on access to affordable high-quality long-term care.

Affordable and accessible care services of high quality offer clear benefits for all ages. Participation in early childhood education has a positive impact on a child’s development and helps reduce the risk of social exclusion and poverty, also later in life. Long-term care empowers people, who as a result of old age, illness and/or disability depend on help for daily activities, to maintain their autonomy and live with dignity. However, for many people these services are still not affordable, available or accessible.

Investing in care is important to attract and retain talents in the care sector, which is often characterised by difficult working conditions and low wages, as well as to address labour shortages and fulfil the sector’s economic and job creation potential.

Entrenching equity in a future pandemic treaty

Equity of access to medicines for the world’s most vulnerable groups is key to a pandemic treaty. While there is unanimous agreement that equity is the essential ingredient in any future pandemic treaty ‘recipe’, World Health Organization (WHO) member states are unclear about how can it be incorporated practically. This emerged from an informal consultation on how to “operationalise and achieve” equity convened on Wednesday by the WHO intergovernmental negotiation body (INB), which has been charged with shaping the treaty or instrument to pandemic-proof the world.

It is the second of four informal consultations planned before the INB reconvenes in December to negotiate a draft agreement to be presented to member states. The first focused on legal issues, while the third – taking place on Friday – will consider the thorny question of intellectual property. The fourth, on 14 October, will consider “One Health”.

Dr Patricia Garcia, former Peruvian Health Minister and professor of public health at Cayetano Heredia University Expert panellists sketched the all-too-familiar picture: WHO member states in poorer countries being unable to get access to vaccines, personal protective equipment (PPE) and other essentials at the height of the COVID-19 pandemic. Garcia, former Peruvian health minister and professor of public health at Cayetano Heredia University said that her country had the highest per capita COVID deaths in the world.

“Even though we had the economic resources, what was really tragic and dramatic was the fact that we could not access any of the products that were needed as an emergency,” said Garcia.  “I’m talking about PPE; and we only had access to vaccines very late, which means that a lot of people died, when in other countries vaccines were already available.”  Dr Ayoade Alakija, co-chair of the African Vaccine Delivery Alliance Dr Ayoade Alakija, co-chair of the African Vaccine Delivery Alliance, said that the number one equity measure in a “binding treaty” should be to ensure manufacturing capacity across all regions.

And that is all for now from EAPM – stay safe and well, and enjoy your weekend.

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