When she entered the Brussels scene four years ago as the European commissioner for health and food safety, Stella Kyriakides did not imagine she would soon become one of the best-known faces in the European Union’s executive bloc.
A Cyprus national and a psychologist by training, Kyriakides, 67, was appointed the European Union’s health chief in 2019 by European Commission president Ursula von der Leyen, hailing from the same centre-right ranks of the European People’s Party (EPP). After a 13-year track record as a member of the Cyprus House of Representatives, the EU role catapulted Kyriakides to the forefront of the fight against coronavirus and the first pandemic in a century.
While almost all her colleagues have tossed their facial masks in the bin, Kyriakides often keeps one in her pocket. “We need to remain vigilant and be ready for all scenarios,” she says.
Kyriakides welcomes The Parliament to her office on the 10th floor of the Commission’s headquarters in Brussels to reflect on what she has achieved in her tenure so far, and look ahead to the next Commission’s priorities. She does this minutes after having unveiled a new policy plan to tackle medicine shortages across the bloc.
The pastel-hued armchairs and sofa arranged around a low coffee table “look nicer than [they are] comfortable”, Kyriakides acknowledges with a smile. But the commissioner is proud of her choice of furniture, one of the few opportunities EU top officials have to give their nondescript, grey offices a personal touch.
Although the current EU administration is nearing the end of its term, several key policy files remain on her desk, from a regulated digital environment for health data, to cancer-fighting strategies, to the reform of the pharmaceutical legislation. (Asked whether she intends to stay in Brussels another five years to continue working on these dossiers, however, Kyriakides hedges.)
All major EU health dossiers fall under the umbrella of the European Health Union, a plan which developed during the first few months of the pandemic to have Member States working together “to improve protection, prevention, preparedness and response against human health hazards”, the Commission writes on the dedicated website.
Since its inception, Kyriakides has been the staunchest advocate of the Health Union, a notion which today enjoys broad support among Members of the European Parliament and national ministers, she stresses. “This was not a given four years ago. It is not for us to judge, and perhaps I should leave [it to] other people to say so, but I believe the Health Union will be one of the key legacies of the von der Leyen Commission.”
The current, wide support for these plans bypasses the fact that the 27 EU countries set their own health policies, and that the EU enjoys limited competence in the area. But the pandemic opened minds to more collaboration at the EU level, Kyriakides explains. “Covid-19 has changed the way we think about health at EU level, showing the need to co-operate not just in times of crisis,” she says. “[The day in December 2020 when] we launched the vaccine campaign at the same time in all EU countries, for me made it clear what we can achieve as a Health Union.”
In Kyriakides’ view, the pandemic years vindicated the ‘one health’ holistic approach she embraced as health and food safety commissioner from her first day in office, an approach that emphasised the close links between human, animal and environmental health. “Many think that my portfolio brings together two separate competences,” she says. “For me, however, that has never been the case. Health and food safety are inevitably part of one responsibility, along with animal welfare.”
Health and food safety are inevitably part of one responsibility, along with animal welfare
Although Kyriakides’ European Health Union umbrella package has largely been backed by national governments, one of its key pillars, an overhaul of the EU laws governing the pharmaceuticals sector, has attracted fierce opposition from innovative industry representatives, and some capitals alike. Unveiled in April after several delays, it will represent the most impactful revamp of EU medicines regulations in 20 years – if the Commission manages to steer it through the legislative process.
The legislative reform seeks to make drugs “more accessible and affordable” across the bloc by adjusting incentives for the development of medicines. It also reduces the timeframe within which the European Medicines Agency and the Commission must greenlight a new drug and give it market authorisation, and speed up the procedures under which generic and equivalent medicines are approved. Among other features, the reform introduces the possibility for countries to decide whether medicines’ package leaflets will be in digital or paper format – or both.
“Access to medicines is at the heart of our Health Union. We want everyone to be able to have access to innovative and affordable treatments regardless of where they live,” the commissioner explains. “Today, however, we find ourselves in a situation where in some countries a new drug is available almost immediately after marketing authorisation, while in others it can take more than two years.”
In short, the EU is trying to create a single market for medications.
Access to medicines is at the heart of our Health Union
To achieve this, Brussels is proposing to remodel the regulatory protection for new drugs, bringing the system which ensures protection from generic and equivalent medicine competitors down from 10 to eight years, while adding what Kyriakides describes as “a reward system of cumulative incentives” for companies that roll out their therapies across the bloc, rather than limiting themselves to the EU’s wealthiest economies.
“The additional regulatory protection of two years if medicines are launched in all Member States is expected to increase access by 15 per cent. This means that 67 million more people in the EU could potentially benefit from a new treatment,” a note by the Commission reads. Drugs would benefit from longer protection under additional specific circumstances, for instance when addressing an unmet medical need or if it is able to treat other diseases.
Kyriakides’ proposed overhaul has been generally praised by patients’ organisations and consumer groups, as well as the generic off-patent sector, which see it as a step in the right direction; at the same time, it has been met with strong criticism from the bloc’s innovative pharmaceutical industry. According to a recent report commissioned by EFPIA, the leading industry group, the new rules would further dampen Europe’s already contracting global competitiveness just as the race to invest in biotech with the US and China picks up.
According to data from the EFPIA, the bloc’s share of global investments in research and development has already shrunk by more than a quarter in the last 20 years. EFPIA’s own analysis estimates that the new rules will cause companies to invest significantly less in R&D, which would lose an additional third of its value by 2040, equating to €2bn less each year. Germany, Belgium and France would be among the hardest hit economies.
Kyriakides sees this differently. “Our intention is to encourage and foster innovation. We want European companies to continue being global leaders. Therefore, under the Commission proposal, we give the possibility to obtain additional protections up to 12 years” when a drug ticks additional boxes linked to public health objectives.
She describes the new rules as laying the foundation for “a situation that is not only superior to the current regime, but among the most generous in the world”. Kyriakides adds: “We are not facing an internal fight within the pharmaceutical industry” between branded and generic products. “What we are doing is to ensure a level playing field that is ultimately intended to create benefits for all citizens.”
Winning the backing of the European Parliament and the 27 national governments represented in the Council for the overhaul is expected to take time, and is unlikely to happen before the end of the current term.
That’s why, last spring, a broad coalition of 20 EU countries called on the Commission to improve the security of medical supplies through a Critical Medicines Act. In June, EU leaders echoed this call and suggested adopting a strategy that the EU’s executive has already applied to semiconductors and critical raw materials, to reduce the bloc’s dependency on a handful of suppliers and boost its autonomy.
Countries are particularly worried about a structural scarcity on the shelves such as the one seen last year, when “essential medicines such as antibiotics, thrombolytics and insulin were particularly difficult to obtain, while antipyretics and painkillers were also in short supply”, the joint appeal co-ordinated by the Belgian government reads.
The EU’s executive body has decided to act, calling on more co-ordination among countries to anticipate selected profiles of the pharma reform, while using tools already available without changing the regulatory environment (for now). The initiative on shortages Kyriakides unveiled at the end of October, minutes before the interview with The Parliament, sought to address these calls by identifying “100 to 350 drugs” to be listed as critical medicines before the end of the year. Critical medicines are defined as drugs “a shortage or lack of supply of which will mean a significant risk for citizens”, the commissioner recalls.
“We cannot afford to wait for the pharma reform to enter into force; we need to take action now for the availability of medicines in the EU.”
The list is meant to be a stepping stone for what comes next, in conjunction with Member States. In the first half of 2024, the Commission intends to convene a so-called Critical Medicines Alliance, bringing together public and private actors, including civil society as well as health and industrial stakeholders, who will be asked to propose actions that the EU can take to diversify its medicine supplies and boost the availabilities of therapies across the bloc.
The next step will be to launch a study paving the way for an impact assessment to determine the future direction, Kyriakides says. “We cannot come up with a legislative proposal [on shortages] unless we have an idea [of] how it impacts on different sectors.”
But impact assessments are usually square one of any legislation spearheaded by Brussels, making it unlikely the current Commission will present a legislative proposal on the Critical Medicines Act before its mandate expires in the autumn of next year.
“We will need to identify the vulnerabilities first, and then we will [define] the best actions to take. [We know that] not all dependencies are vulnerabilities,” the Cypriot politician says when asked about concrete measures to ensure the reshoring of the production of the key pharma ingredients that are normally sourced from outside Europe, typically from China or India.
The October initiative on shortages was announced alongside a voluntary solidarity mechanism that would kick into force in exceptional circumstances. “When a Member State experiences shortages, it can connect with another EU country that has a surplus of that product, which can agree to share its stocks,” the EU health chief explains. “This may seem quite obvious, but has never been structurally done before. This is the power of co-operation.”
The Commission will, in parallel, step up joint procurement of antibiotics and treatments for respiratory infections as early as the winter of 2024-25, in the same way it tackled bloc-wide vaccine procurement during the pandemic, and made joint gas purchases to ease the energy crisis after Russia’s invasion of Ukraine. EU countries will, in addition, be advised to stockpile contingency medicines; to facilitate the marketing of galenic preparations by pharmacies; and to temporarily extend the expiry dates of certain drugs.
Among the files she oversees, there is one that Kyriakides holds dear due to her previous life as patients’ rights advocate and her own experience as a breast cancer survivor, as the pink ribbon she wears during the interview shows.
In the early 2000s, before she joined Cyprus’ parliament as a lawmaker, she served as the president of Europa Donna, the European Breast Cancer Coalition – an experience which she says has influenced her work at the Commission. She has, for instance, insisted on adding a seat for patients’ rights representatives in the main scientific committee of the EU Medicines Agency: “Only by talking to people and bringing them onboard we can achieve progress.”
Nothing in health is static
It came as no surprise, then, that the €4bn Beating Cancer Plan was among the very first initiatives she launched when she assumed office in 2019. Currently in its third year, Kyriakides says it has already produced concrete results. “In the fight against cancer, we have achieved more in this short time span than in the last 10 to 15 years. For example, we have adopted new recommendations on cancer screening and started to introduce the right to be forgotten for oncological patients to avoid discrimination in access to financial services.”
Another frontier, one where the road ahead is still long, is mental health. According to figures from the Commission, one in six Europeans experienced mental health issues prior to the pandemic. Now, with economic, geopolitical and climate crises all together, going beyond physical health is fundamental.
“When I started talking about mental health here in Brussels a few years back, it was not a priority for anyone,” Kyriakides remembers. “The pandemic once again has shown a change of pace. Mental health is being raised at every EU ministerial meeting; people are talking more and more about it. That is a success in itself”.
In June, the commissioner presented a first-ever EU policy document in this domain, “to break the stigma and the discrimination surrounding mental health” and encourage countries to share good practices existing at local levels.
“Nothing in health is static,” Kyriakides says when asked about the priorities that should top her successor’s list, hinting at the fact that the next EU health chief will need to keep the ball rolling and continue the implementation of the European Health Union. “They will have a great deal to build upon. If I have to pick a subject, though, the area of rare diseases is one I would focus on, learning from the Beating Cancer Plan blueprint.”
The print version of this interview stated that the proposed legislative reform 'sought make drugs “more accessible and affordable” across the bloc by rewriting intellectual property rights.' This is incorrect, and should have said that the reform seeks to make drugs "more accessible and affordable" by adjusting incentives for the development of medicines. We apologise for this factual error.