José Inácio Faria MEP, Group of the European People’s Party (Christian Democrats) explains the approach of taking advantage of the EU scale to improve national healthcare systems
Even if healthcare is a Member State prerogative under the subsidiarity principle, the future ahead will pose several threats that will benefit from a European approach, one that will focus on better outcomes in health and pave the way to health systems performance optimisation.
Member States individually and also collectively – out of the European budget – have been financing innovation especially in areas where a low return on investment does not allow for private venture. Still, the sustainability of healthcare has been put at stake with the high price of new technologies. Politicians now see with some suspicion whether innovation actually translates into greater benefits, or if the incredible amounts of money are not proportional to the little added value that these products, sometimes, actually bring. Centralising the clinical part of HTA in Europe has the potential to introduce more fairness inaccessibility to true innovation for European citizens. Unfortunately, this will not translate immediately into higher affordability.
Our cheap old medicines in the market can be found to have new uses – repurposed medicines. Many candidates for repurposing are widely used low-cost generics. For example, the Repurposing Drugs in Oncology project identified more than 230 licensed non-cancer drugs with data supporting anti-cancer activity, of which over 75% are off-patent. As the drugs are already in routine clinical use, early phase clinical trials can be bypassed, saving time and money. The same happens with combination therapies that use cocktails of inexpensive drugs with their synergic effect being greater than the sum of their parts. However, research in these areas is harder as the funding pathways are meagre because of the low-appealing financial return.
With the passing years, as medicines for cancer become less expensive, they become scarce in the market for more reasons than one. While stakeholders are entertained in the blame-game, passing on the responsibility for these shortages, none of them actually looks into his partaking in solving the problem.
The shortages of inexpensive essential medicines are a growing public health emergency that requires concerted and collaborative action at European Union (EU) level. While there is a clear impact of shortages on patient outcomes, the causes of shortages are complex and multifactorial – such as manufacturing planning, parallel import/export and poor reporting mechanisms – and cannot be solved by any Member State alone. Many European countries across the range of the EU are facing shortages of essential medicines and this pressing issue is currently threatening patient safety across Europe and severely limiting the ability of physicians to provide effective treatment regimens.
The impact of shortages, even for inexpensive essential medicines, has a significant impact on patient care. The lack of these crucial medicines can lead to failure to treat, delayed treatment and the use of less desirable, often expensive, alternative products. This is of particular concern in the field of oncology where, in many cases, there are no alternatives. Thus, shortages negatively affect both the health of European citizens and the sustainability of European healthcare systems through increased costs. For children diagnosed with cancer, the situation can be particularly devastating as the medicines affected by shortages are curative and with few proven effective alternatives.
In addition, at the operational level, health professionals such as hospital pharmacists incur on major time losses in trying to find alternative treatments for patients, which, in turn, leads to increased costs for healthcare systems and higher costs of alternative treatments for payers. What is more, shortages have a direct economic impact on patients where the substitution with higher- cost medicines may fuel individual out-of-pocket payments.
It is my sincere belief that a European solution is required to tackle the problem as no one measure will suffice. Recommendations of the European Society for Medical Oncology endorsed by other stakeholders, health professionals and patient associations as well as several civil society organisations, have made the path quite clear. At the start of all measures, we need a clear definition of what constitutes a “medicine shortage” and this needs to be consistent throughout Member states. There is also a need for national strategic plans for medicines shortages, lists of essential medicines and legislation for early notification of supply disruptions. We also need to consider the financial incentives in place to address the economic causes of shortages and make essential shares of medicines remain on the markets where they are intended and manufactured for. Intervening on the pricing mechanisms can be an alternative, not necessarily imposing prices at the national level but establishing minimum indexed prices for exports in the EU.
National health systems face several other challenges and are not immune to the European single market. While this can be one of the reasons for shortages, as the low prices in some countries make it appealing for over-exploitation, it is also true for health professionals who will also be scarce in the future, according to the social sciences projections. Other challenges rise in the area of prevention and early detection as this has been deemed the smartest way to invest in health systems, even if outcomes are only measurable much after each government’s mandate. I believe that cross-party longitudinal agreements for healthcare are the way forward in order to save avoidable health interventions and to curb higher costs of advanced stage treatment.
According to recent findings by the EU Expert Group on Health Systems Performance Assessment, 20% of current expenditure in modern health care systems can be categorised as either ineffective or wasteful. Handling these inefficiencies correctly can save part of the budget without unintended consequences on accessibility or on the quality of care.
The burden of disease is too high for negligent approaches. Health systems need more tools to work and the European scale and its solidarity model, which stands exemplary as a beacon for the rest of the world, can be a solution to many of the challenges at hand.
José Inácio Faria MEP
Group of the European People’s Party (Christian Democrats)
Tel: +32 2 28 45454
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