The European Commission will soon present its long-awaited pharmaceutical strategy. This will address a problem that was already apparent before the Coronavirus crisis, but is one that has worsened drastically as a result of the crisis - shortages of certain medicines. The issue of securing the availability of medicines in the European Union must therefore be part of every future strategy.
The question is quite simply whether, and to what extent in order not to jeopardise our security of supply, we wish to be dependent on third countries for the production of medicines and active ingredients. Even with relatively simple products such as protective masks, the Coronavirus crisis has shown us how dependent we now are on such supply routes.
Short-term measures, such as the creation of a strategic reserve for personal protective equipment or the joint procurement of medical equipment, medicines and vaccines from all EU Member States, were quickly implemented to solve short-term problems. However, we need long-term solutions. What market-based instruments do we want to use and how much public governance will be required to improve supply chain diversification and create incentives to shift production back to Europe?
“The main reasons for the increasing dependence on third countries in medicines production are that, in recent years, health insurance companies or state health authorities have paid attention solely to the costs of production, while the important issue of security of supply has not been a factor”
In my view, the main reasons for the increasing dependence on third countries in medicines production are that, in recent years, health insurance companies or state health authorities have paid attention solely to the costs of production, while the important issue of security of supply has not been a factor in tenders. We must therefore create the framework conditions where the production of medicines in Europe is worthwhile.
We cannot accept the case that the supply of medicines for seriously ill patients or the safety of nurses is dependent on a single factory in China or India, whose production may fail or where they cannot export due to government intervention. Let me be clear: we must not be dependent on a single factory in Europe either, since its production may also be interrupted. Tendering by health services and health insurance companies must therefore also include criteria other than price alone, for example security of supply.
My suggestion would be that at least two production plants for the active ingredient must be available, at least one of one of which must be in Europe. In this case, we would be protected against interruptions to production due to accidents, but also by other measures such as export restrictions.
We must also find the best way to overcome market failure – where the development and production of some urgently needed medicines is simply no longer worthwhile for manufacturers and often simply abandoned. A high-profile example is the issue of antimicrobial resistance. Already today, 40,000 people die in Europe each year because antimicrobials are no longer effective, and experts are already talking about the possibility of a Post-Antibiotics era.
This serious problem unfortunately remains completely under the radar. We need new antibiotics on the market quickly to save lives, but pharmaceutical companies quite rightly assume that new antibiotics, when they come on the market, will only be used under very strict conditions. This is perfectly correct, as their widespread use would immediately risk new resistance.
“We must therefore create the framework conditions where the production of medicines in Europe is worthwhile. We cannot accept the case that the supply of medicines for seriously ill patients or the safety of nurses is dependent on a single factory in China or India”
They must therefore only be the means of last resort. Companies cannot be accused of not investing in a product that will end up costing them dearly. That is why we need a legal framework for such cases, one which enables companies to undertake this research and make it available and - if necessary - commits them to it. We already have a similar legal framework at European level for paediatric medicines, for example.
Here, we established a system of incentives and obligations several years ago, which has brought great benefits for young patients. The EU pharmaceutical strategy should therefore urgently address this problem.
EU PHARMACEUTICAL STRATEGY FOR EUROPE
According to the European Commission, citizens across the EU expect to benefit from equal access to safe, state-of-the-art and affordable therapies. Medicines play an important role as they offer options for diagnosis, treatment and prevention of diseases. Europe’s pharmaceutical sector is a major contributor to the EU economy in terms of creation of highly skilled jobs and investment in innovation. The EU believes digitalisation and innovation in the use of data can open new possibilities in how medicines are developed and used.
However, innovative therapies do not reach all patients across Europe quickly, and patients might not have access to medicines when they need them. The unprecedented COVID-19 pandemic has further demonstrated how important it is to have a crisis-resistant system and ensure availability of medicines under all circumstances. At the same time, Europe’s population is ageing and faces a rising burden of diseases and emerging health threats. Compounding this issue, health systems and patients have difficulty bearing the cost of medicines.
The EU is also becoming increasingly dependent on third countries for importing medicines and their active ingredients. Issues such as antimicrobial resistance and environmental sustainability of medicines are also a concern. The EU’s Pharmaceutical Strategy for Europe aims to address these issues by creating a future proof regulatory framework that supports industry, promotes research and technologies that reach patients, fulfilling their therapeutic needs, and addresses market failures. It will also consider the weaknesses exposed by the Coronavirus pandemic and factor in appropriate actions to strengthen the supply of medical drugs.