Guest article by Charlotte Roffiaen, European Policy Advisor at France Assos Santé
For many years, the increasing prices of innovative medicines have focused the attention of the European public health community. Affordability issues were threatening both patient access to treatments and the sustainability of national healthcare budgets. This has long overshadowed another raising access issue that French patient organisations started reporting in 2009: the multiplication of medicine shortages. The COVID-19 pandemic has overturned the situation and medicine availability is now high on the EU health agenda. The revision of the pharmaceutical legislation is a unique opportunity to adopt a bold patient-centred policy on medicine shortages based on public health considerations. Let’s join forces to make this happen!
Medicine shortages are reaching unprecedented levels across Europe
Medicines shortages are not a new phenomenon in the EU but their exponential increase over the past years is striking. In France, 2,446 shortages of medicines of high therapeutic interest have been notified in 2020, compared to 1,504 in 2019 and 868 in 2018 (they were 44 in 2008). The numbers are still much higher in EU countries that register shortages of all medicines: in 2019, they were 6.633 in Portugal and 4.816 in the Netherlands!
Patients and healthcare professionals report dramatic impacts on health
According to EAHP 2019 European survey, almost one in two patients (47%) had experienced medicines shortages to their own person or by a family member. The unavailability of a medicine has an immediate impact on patients’ health. Delays in care and therapy (42 %), suboptimal treatment (28 %) or cancellation of care (27 %) are the most frequent consequences reported in EAHP study. This can worsen symptoms, cause disease progression, or even decrease patients’ life expectancy: according to a survey published by the French Ligue against cancer in 2020, two in three medical oncologists (68 %) consider that shortages of anti-cancer medicines have an impact on the chances of their patients to survive another 5 years. The high prevalence of shortages among anti-infectives and antimicrobial agents also contributes to the development of antimicrobial resistance and to the diffusion of infection diseases.
If price is the issue, cost transparency and public production are the answers
The generic industry is very vocal in asking for price raises as a response to the current shortage situation. It considers low prices of older medicines have contributed to weaken the supply chains and are the indirect cause of many medicine shortages. Without a full cost transparency, it is yet impossible to document situations in which prices do not allow for a reasonable profit margin. Cost transparency should also apply to new medicines and help rebalance the whole pricing system.
The public (or non-profit) sector – including hospital pharmacies – should also be allowed to produce medicines that have been withdrawn from the market or are not available because of price issues. This possibility needs to be included in the revised pharmaceutical legislation.
The diversification of production sources should be preferred to the reshoring of medicine production
The COVID-19 pandemic has once again highlighted Europe’s dependency on third countries – especially India and China – with the reshoring of production being presented as a key remedy to strengthen medicine supply chains. We consider the objective should rather be to diversify production sources of essential medicines, focusing on raw materials and API (active pharmaceutical ingredients). Any public incentive also needs to be exclusively based on patients and public health needs, and conditioned to full transparency, supply obligations and prices conditions.
The EU pharmaceutical legislation should set stringent notification and supply obligations
When the Directive 2001/83/EC was adopted, medicine shortages were not considered as an issue in Europe. As a result, it only includes general obligations for market authorisation holders (MAH) and distributors to ensure appropriate and continued supplies of medicinal products, and for MAH to notify health authorities if a product ceases to be placed on the market temporarily or permanently.
The current revision of the EU pharmaceutical legislation is a unique opportunity to adopt a bold patient-centred set of rules on the prevention and management of medicine shortages. The objective is to redesign the EU notification and supply obligations, aiming at the highest level of patient protection. Longer notification periods, safety stock obligations, stock transparency, shortage prevention and management plans are among the key measures that need to be adopted, making the pharmaceutical industry accountable for the fulfilment of its duties with dissuasive sanctions in case of non-compliance.
Disclaimer: the opinions – including possible policy recommendations – expressed in the article are those of the author and do not necessarily represent the views or opinions of EPHA. The mere appearance of the articles on the EPHA website does not mean an endorsement by EPHA.