The word of the year is: polycrisis

In March 2020, the rest of Europe was transfixed by images of a healthcare system collapsing as COVID cases piled up in Lombardy, Italy, imminently expecting similar scenes to hit their hospitals. Fast forward nearly three years and European healthcare professionals are watching queues of ambulances outside UK hospitals, predicting the same scenario in their countries soon.

Against crisis backdrop, we know that industry voices have a shopping list of asks for European governments: increased investment in innovation to catch-up with the US; cooperative usage of data; novel approaches to technology evaluation and appraisal. Industry leaders say these amount to a call to target wholesale transformation and move to an ‘ideal’ healthcare system, rather than tinkering at the edges.

The polycrisis European health systems face will make it hard for these voices to get a hearing, even as system collapse tells us we need a more radical approach.

As this newsletter covers, 2023 will see varied responses to these issues. While France is pushing ahead with a renewed focus on prevention, Italy has placed a major primary care reform on hold. As Germany is looking to control its healthcare spending, Spain’s Government is pushing through pioneering changes in reproductive health.

This is our most comprehensive newsletter yet – if you have any questions about the topics raised, do get in touch.

Noah Froud, Charlotte Moss and Isabelle Scali

The biggest voice in European health policy: US Senator Bernie Sanders

Vermont independent and Medicare-for-all proponent Bernie Sanders is set to take over the Senate’s Health, Education, Labor and Pensions Committee next month, giving him oversight over key health policy priorities such as drug pricing. What happens in Washington inevitably influences European politics, and there’s potential for appearances by industry leaders in front of the Committee to be picked up by European media – just as Mark Zuckerberg’s were. POLITICO has chronicled how US lobbyists are preparing for challenges given the Senator’s well-chronicled antagonism towards them.

France:

Social Security Financial Bill to cap health products cost to state

The new  PLFSS (“Social Security Financial Bill”), which entered into law in December 2022, came into effect this month, ushering in multiple changes to the French health system. This act offers little flexibility for interpretation during the implementation process. While CEPS (“Economic Committee of Health Products”) will have some decision-making control over establishing reimbursement costs for certain advanced medicinal therapy treatments (AMTPs), most pricing and social regulations under the PLFSS have already been finalised. Excluding COVID-19 spending, budget growth for reimbursement of health products by insurance has been limited to a conservative 3.5 per cent (€244bn), in keeping with previous ONDAM (“National Goal of Health Insurance Spending”) targets. Projections for 2023 forecast a national social security balance of -€7.1bn, from 2022’s budget deficit of -€18.9bn. However, the restricted drugs budget has been decried by some outlets as a threat to industry innovation and barrier to patient access.

New services including ‘prevention appointments’ and screening for sickle cell

Prevention is a central focus in the French Government’s public health strategy. From 2023, ‘prevention appointments’ will be established for citizens at key age milestones (20-25 years; 40-45 years; and 60-65 years). The National Newborn Screening Programme is expanding its systematic testing of 3-day-olds in France to include 7 additional congenital diseases (including homocystinuria [HCY], leukinosis [MSUD], and tyrosinemia type 1 [TYR-1]). At the recommendation of HAS (“High Authority for Health”), screenings for sickle cell disease will also now be conducted across all newborns, including those in low-risk populations. This expansion we be trialled over the next three years. Free and non-prescription access to emergency contraception will now be made available to all women and non-prescription testing for STIs will be fully reimbursed for under 26s. Tobacco prices will also rise substantially as a continuation of the PLNT (“National Tobacco Control Programme”).

France to introduce reference pricing

HAS has made a concerted effort to improve the transparency of their market access decision-making over the past year. Now CEPS (“Economic Committee for Health Products”) will be expecting the same of industry. First, the PLFSS aims to use discount levers (paid to health insurers) to encourage further claims for reimbursement across all eligible indications, moving away from indication-specific claim strategies. Secondly, under new ATMP financing, payments to the manufacturer will now be spread over time, at key milestones based on real-world evidence of treatment efficacy even after reimbursement approval.

Finally, under the PLFSS, CEPS will introduce reference price groups and additional evidence requirements following market access approval. This aims to guarantee proportional reimbursement for product outcomes and encourage use of comparable cheaper alternatives or generics. This follows a similar approach to other EU systems. However, the impact on generics uptake is uncertain without additional patient or prescriber incentives.

Germany:

Cost-containment measures to be introduced

Long since one of the most attractive EU markets for pharmaceuticals, Germany is adopting cost-containment measures that are set to significantly impact industry revenue and R&D in the country. In light of the statutory health insurance system (GKV) facing financial difficulties, the Bill on the Financial Stabilisation of the Statutory Health Insurance System (‘GKV-Finanzstabilisierungsgesetz’) passed through the Bundestag and the Bundesrat in October 2022.

The Bill aims to distribute financial burden across all healthcare players without reducing patient benefits. Changes in reimbursement pricing mean the period in which a pharmaceutical company is free to set its price for new medicines is reduced from 12 to six months. The German Government has also stated its expectation that future price negotiations will also consider price-volume components. Meanwhile, orphan drugs will be subject to the full AMNOG process (including HTA assessment) if their annual revenue exceeds €30 million – a tightening of the current €50 million bar which has drawn concerns from smaller pharmaceutical companies, particularly in the rare disease space. Reactions to the Bill have been mixed, with some stakeholders voicing concerns that the Bill is a quick fix rather than a long-term solution to stabilising GKV finances.

While the rest of 2023 is likely to reveal further cracks in the running of Germany’s health system, the GKV Bill may well have a broader impact for many years to come. Besides the possible stagnation of R&D and innovation within Germany, the Bill could affect innovative therapy pricing beyond its borders, as German pricing is often used as a reference for both EU countries and others such as Canada, South Korea and Japan.

Alert level red

Amid recent mass resignations in Germany’s hospitals, staff have cited a workload so extreme that some were unable to take even a short break or go to the toilet. In a country that spends more on healthcare than almost any other in the world, this is triggering widespread alarm. The Health Minister, Karl Lauterbach, announced a plan to move nurses and doctors around to match demand that has been dismissed as “absurd” by leading clinicians; the Süddeutsche Zeitung stated that the country was witnessing “what it means when a system implodes”.

What lies ahead for Germany’s coalition?

Cost-containment measures can be viewed as a stress test for the so-called ‘traffic light coalition’, with social democratic Mr Lauterbach (SPD) and the liberal Finance Minister Christian Lindner (FDP) both key players. Mr Lauterbach also featured in the news towards the end of 2022 when German police revealed they had thwarted a far-right terrorist group’s plot to kidnap the Health Minister. The planned attack has been interpreted as an extreme response to Mr Lauterbach’s cautious approach to COVID-19 and follows the rising trend of renewed political extremes in countries generally regarded as stable democracies. Suspicion of vaccines and opposition to lockdowns and mandatory mask-wearing have provided fertile ground for healthcare issues to accelerate extreme political movements since the beginning of the pandemic.

Spain:

Overstretched frontline staff

In December, El Mundo spoke with Professor Verónica Casado, former Minister of Health for the Junta de Castilla y León and internationally renowned family doctor. The discussion centred on the apparent lack of doctors across Spain. Professor Casado, however, dispelled this notion and stated that there have never been so many doctors, but the distribution of specialties is “very chaotic” with 18 specialties being classed as “very deficient”. Looking towards 2023, Professor Casado suggested the introduction of a specific MIR (Resident Medical Intern) for the 18 specialties most at risk might be one resolution, but also noted that this is a multi-causal issue. This takes place against the backdrop of a more widely reported issue of many doctors in southern Spain leaving the area in pursuit of better pay and prospects, as well as numerous planned doctors’ strikes.

Sexual and reproductive health policy

Towards the end of 2022, Spain’s Parliament passed a pioneering sexual and reproductive health law. This law removes a mandatory three-day “reflective” period for women who wish to terminate a pregnancy and removes the need for those aged 16 and 17 to obtain the consent of a parent or guardian to abort, which is a first for a European country. Other changes included amends to maternity pay, menstrual products and surrogate pregnancies. The law was adopted with a 190-154 majority with five abstentions, although those against were resolute in their opposition: Lourdes Mendez from the far-right party Vox believes the law “violates the constitution and has turned Spain’s system of values upside down”. The law is now with the upper house for final approval but – given the far-right party Vox won a 15 per cent vote share in the last election – we expect a hostile response from some of the Spanish public.

Italy:

New Government divided on health

Italy’s recently elected Government of right-wing parties, formed by Giorgia Meloni’s Fratelli D’Italia (Brothers of Italy) (FdI) and its junior partners La Lega (the League) and Forza Italia (Come on Italy) (FI) have differing views on healthcare. FdI favour a more centralised system. Their partners Lega and FI favour regional autonomy and privatisation, in the model of Lombardy, which is publicly funded but also supported by the private sector.

Italy’s governance system allows unelected specialists to serve in Government as “technical” Ministers, meaning they do not have a political background; this has allowed the parties to agree on a compromise Health Minister Orazio Schillacci, who is not affiliated with any of the ruling parties. Schillacci previously served on the Scientific Committee at Italian National Institute of Health as a researcher, appointed by Roberto Speranza, the previous Minister, which fed into PM Mario Draghi’s Government’s public health decisions during the pandemic. This may be an indication that they recognise the scale of the challenges ahead and are choosing to take the health brief seriously. However, it could also signal a lack of political ambition. As the Government was elected in September and had to pass a rapid budget by December, there were no new landmark health projects announced. It is yet to be seen what direction the Government will choose to take, preferring to focus now on the cost-of-living crisis through support for families and tax cuts.

Private-public partnerships under scrutiny

According to the bureaucratic structure in place since 1992, healthcare services are regulated by the Government, but the regions have autonomy over budgets, spending and provision. This has led to a patchwork of local systems that have opted for varying degrees of privatisation. It is now understood that the Lombardian private-public model resulted in one of the worst death rates of all the regions during the pandemic. Silvio Berlusconi’s FI and Matteo Salvini’s LI parties have governed the region since 1995 and allowed private and public systems to compete for funds based on efficiency. Praised as one of the most advanced healthcare systems in Italy, it also meant that private firms invested in areas that would generate more revenue, leading to a reduction in hospital beds and a decreased capacity to combat a sudden emergency. This arguably contributed to the area’s poor outcomes compared to neighbours with higher levels of public funding Veneto and Piemonte.

Health spending frozen in real terms

Spending cuts in the previous decade left the Italian health system weak as the country in the G7 with the lowest healthcare funding since 2008, which may have contributed to its status as a country with one of the highest death rates in the EU. Whilst the recently passed budget law in December increased healthcare spending by €2.15 billion for 2023 and a further €2.3 billion in 2024, €1.4 billion of this funding will be going towards covering high energy costs for hospitals, and the remaining money covers inflation, so will not be enough to properly address some of the outstanding issues.

Workforce shortage expected to worsen

There is a chronic shortage of healthcare workers. The ANAAO (National Association of Hospital Assistants), Italy’s largest doctor’s union, estimates that based on current trends of retirements and layoffs, there will be a total loss of 40,000 medical specialists by 2024. Plagued by long working hours, lack of staff, heavy bureaucracy, poor social and economic recognition, and assaults and accidents at work, more staff might opt to head for the door too.

Educational bottlenecks resulted in fewer doctors being trained than were needed in the system, whilst a large number of doctors have retired in recent years. Measures were introduced by the last Government to expand medical school places and training residencies, but it may be another few years before their impact is felt. Additionally, some residencies are undersubscribed, such as emergency medicine, microbiology and anaesthesiology. The new coalition Government repealed the regulation barring unvaccinated healthcare workers from work in October partly to reverse the departure of 4000 healthcare workers, and throwing their COVID-sceptic base some red meat. As in the UK, this has led to a reliance on locum doctors (called “token” doctors in Italy). Schillacci has acknowledged that to some extent, making certain disciplines more attractive to specialise in and stopping the exodus to the private sector will require better pay and flexibility.

Primary care reforms on pause

Italy’s primary care problem has been exacerbated by the pandemic. We’ve noted previously that the EU Commission’s National Recovery and Resilience Plan (NRRP) included €7 billion of NRRP funding toward local health centres known as “community houses,” in which primary care would be supported by enhanced laboratory facilities for testing and diagnostics, enhancing screening capabilities and reducing pressure on hospitals and long-term costs. Schillacci has signalled that this might not be the solution the Government takes, and this will need to be evaluated. As the NRRP money is still largely unspent, and is the only ‘additional’ money available, what Meloni’s Government chooses to do with this will be significant.

Brussels:

European Commission mental health strategy pencilled in for Q2 2023

The EU’s health chief Stella Kyriakides had previously commented in October that the Commission is supporting member states to reform mental health systems and has allocated more than €28 million to mental health actions under the EU4health programme over the last three years. How the Commission plan to build on this with its mental health strategy is currently unknown, but – based on President Ursula von der Leyen’s State of the EU speech last September – it appears to be a top health priority for the upcoming months.

European Council to decide on medical devices transition timeline

Later this year, health ministers will formally vote on the European Commission’s proposal to extend the deadline for the transition period of medical devices regulation (MDR) from 2024 to 2027, following concerns that delays in the regulation’s implementation are creating shortages of devices used by health services.

Orphan products and pharmaceutical legislation?

In November 2022, the Commission promised MEPs that they expect to adopt the proposal for revising the orphan medicinal products legislation in the coming months – albeit without providing a specific date. The current legislation was introduced in 2000 to better incentivise those developing orphan medicines; the Commission evaluated the legislation revision in 2020 but adoption of the proposal has been continually postponed.

Following a similar path of delays, pharmaceutical legislation revision should have been presented in December 2022 but as yet remains unseen. The Commission says the new legal framework will ensure access to quality and affordable medicine but, in its response to the public consultation on the revision, the European Federation of Pharmaceutical Industries and Associations (EFPIA) argue that ensuring faster, more equitable access “cannot be achieved through the revision of legislation and an incentives framework”, and instead must be addressed through stakeholders understanding the root causes of access barriers and jointly finding solutions to these delays.

Isabelle Scali

Associate Director

Former Global Corporate Communications Director at ViiV Healthcare, Isabelle has 20 years of strategic communications experience.

Noah Froud

Account Director

Noah is the brains behind our newsletter, and previously worked for a Member of the European Parliament.  He’s an unashamed health policy nerd and has his finger on the pulse of UK and European developments.

Charlotte Moss

Account Manager

Charlotte is well versed in European policy, having studied Governance, Economics and Development in The Hague, the heart of European justice and political capital of the Netherlands.

Neil Moscovici

Account Manager

Neil holds an MA in Geopolitics and Grand Strategy, and before joining MHP worked for the European Committee of the Regions in Brussels.

Laurence Childs

Account Manager

Laurence joined MHP from the UN Office of Drugs and Crime in Vienna. He holds an MSc in International Health Policy and has a background in market access.

Matteo Bellani

Account Executive

Matteo joined MHP in 2022 from ViiV Healthcare, where he worked in Pharmacovigilance and Regulatory Affairs.  Matteo is a specialist in HIV advocacy and holds a first class degree in Biochemistry.