In this series, Hanover Health’s International Policy and Market Access (IPMA) EU policy experts will take you through the upcoming legislative and non-legislative pharmaceutical and healthcare proposals at EU level and help you decipher their impact and what to do.
European Commission lays out a flagship initiative in healthcare
The European Commission’s Beating Cancer Plan was published on 3 February 2021, ahead of World Cancer Day. It details the Commission’s strategy to address rising rates of cancer within the EU in the coming years. As a key part of the Commission’s overall ambition to drive action in healthcare, it is important to unpack the complexities of the Plan, provide a no-frills assessment of its context and most important elements, and analyse what comes next.
Coming out against the backdrop of COVID-19 and a stuttering Europe-wide vaccination drive, the Beating Cancer Plan might seem to be overshadowed by ongoing events. However, the current pandemic makes the Plan especially critical: cancer patients are at even greater risk in pandemics, as many may be undergoing chemotherapy, which can drastically reduce the immune system’s ability to fight off diseases.
Delayed multiple times throughout the pandemic, the Plan’s release provides concrete steps and recommendations to move forward in tackling cancer, with €4 billion being earmarked for the cause. The Plan was welcomed by many cancer stakeholders, including the European Cancer Organisation and the European Cancer Patient Coalition, with many believing it to be a turning point in the fight against cancer.
Why cancer and where does this plan originate?
Intriguingly, the Commission has chosen cancer as the overarching topic for a flagship health initiative, which can encompass several healthcare challenges at once. Included is heart disease, which is the number one cause for mortality in Europe, tobacco consumption and rising obesity levels. The Plan also incorporates other elements such as air and chemical pollution, to create a comprehensive and cohesive plan to tackle many of the underlying causes of cancer.
The concept of a Cancer Plan had significant support from the beginning, given worrying EU figures projecting a 24% increase in cancer deaths by 2035. The push for a flagship initiative around cancer was led by the European People’s Party (EPP) in the European Parliament. It has been supported by the fact that the EPP Group holds a trio of important and influential positions within the Commission in President Ursula Von Der Leyen, Vice President Margaritis Schinas and Health Commissioner Stella Kyriakides.
A Special Committee on Beating Cancer (BECA) was set up within the European Parliament in September 2020, chaired by Member of the European Parliament, Bartosz Arłukowicz (Poland, EPP), with a mandate of at least 12 months. BECA is tasked with assessing opportunities for concrete EU action, outlining possible legislative opportunities and other means to tackle and prevent cancer. BECA also provided its input on the Plan in a Working Document, which listed several areas for action and described the need for greater shared knowledge throughout the EU.
What is in the Beating Cancer Plan?
The Plan details several key areas for assessment and analysis, such as preventative healthcare, early detection, diagnosis and treatment, as well as mentioning a handful of ongoing policy efforts. The Plan also delves deeper into the topic of inequality of healthcare access between Member States.
Preventative healthcare: Prevention is being prioritised as the Plan vigorously targets tobacco, including e-cigarettes, and alcohol consumption. The Commission is targeting a “Tobacco Free Generation” in which less than 5 percent of Europeans use tobacco by 2040 and will review EU legislation on alcohol taxation and attempt to reduce the amount of online alcohol advertisements. The combined efforts against both the alcohol and tobacco industries could be considered courageous, given that the European trade associations of both industries alone each spent upwards of half a million euros on lobbying in 2019i ii. Despite this, however, many MEPs have signalled their support for these bold moves.
Early detection: An EU cancer screening scheme was announced, which is an encouraging step in securing greater health equality and allowing a high proportion of the EU population to benefit from early diagnosis or preventative care. A further initiative called “Cancer Diagnostic and Treatment for All” will look to tap into next generation sequencing technology to ensure earlier detection of cancers and optimise diagnoses and treatments. Such technologies are just beginning to enter the European market to treat the underlying genetic components of certain diseases.
Diagnosis and treatment: As part of the Plan, a Knowledge Centre on Cancer will be established in early 2021, to coordinate scientific and technical cancer-related initiatives at EU level. A new project entitled “Genomic for Public Health”, looking at the genetic component of cancer, and a novel “European Cancer Imaging Initiative” will assess the use of genomics technologies in dealing with cancer and establish a database for cancer images. This is intended to contribute to the delivery of first-class treatments and personalised medicines to EU citizens in the future. A “Cancer Inequalities Registry” will also be created to provide 90% of eligible patients with access to cancer centres by 2030 and reduce glaring gaps in EU healthcare equality.
The Plan also announced the launch of an action to create an EU platform to improve access to cancer medicines by supporting the repurposing of existing medicines. This is another encouraging move to maximise the value of previously developed medicines.
EU Policy: Other elements highlighted in the Plan include the ongoing health technology assessment (HTA) proposal, currently stuck in legislative limbo in the European Council, and the upcoming revision of the EU Orphan Medicinal Product (OMP) and Paediatric Regulations. The HTA proposal would allow for joint clinical assessment of innovative health technologies, however, it has been plagued by EU member state concerns about whether it oversteps the EU’s competences. The revision of the EU OMP and Paediatric Regulations could impact the business models of pharmaceutical companies by altering the existing incentivisation mechanisms which have allowed for a dramatic rise in treatments for rare disease and paediatric medicines in the past 20 years.
Beating Cancer Plan in the broader view of EU healthcare and environmental activities
The broader Pharmaceutical Strategy laid out by the Commission in November 2020 also contributes to the Plan. This is part of a two-pronged approach in increasing uptake for generic and biosimilar medicines and boosting “innovation to address unmet needs, including vaccination against treatable infections that cause cancer, as well as medicines for paediatric and rare cancers.” The Strategy describes how both in combination will play crucial roles in ensuring that cancer patients receive high-quality and affordable treatments and new therapies across the EU.
Europe’s Beating Cancer Plan will interact closely with other initiatives, such as the Green Deal and the Zero Pollution Strategy, to tackle contaminants in drinking and groundwater, soil pollution, and air. Overall, the overlap of these major EU initiatives is pleasing to see, as it represents a cohesive and all-encompassing approach to tackling cancer.
There is expected to be some pushback from EU member states, with many unwilling to relinquish control over the provision of healthcare, which is a national competence. This is despite firm assurances that the Plan is meant to be complementary to national level healthcare coordination, rather than overriding it.
Although the Plan is clear on which funding instruments will be used for each pillar, there is still a need for greater precision in the detail. A slew of initiatives and projects have been proposed to kickstart different elements of the Plan, but these are often undefined in scope or are scheduled to begin at a later date. Other questions might be raised about the high price tag – €4 billion – given the ongoing recession within Europe.
The Plan is undoubtedly a positive step forward in dealing with an important healthcare issue and reducing incidences of cancer in Europe. The road ahead is far from certain and interested parties must navigate these complex waters carefully, to assess the Commission’s upcoming balancing act of all the relevant stakeholders and their needs as the plan is rolled out. For stakeholders, now is the time to be proactive, in order to shape the cancer policy environment for the years to come.
Hanover’s IPMA team is a leading international policy and market access team in Brussels. We work with businesses and trade associations to bridge the gap between their business objectives and the policy environment they operate in.