Harmonising access

With medicine shortages and inequalities in access on the rise in the EU, there is a pressing need to shift more healthcare powers to the EU institutions, explains Katerina Konečná.
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By Katerina Konecná

01 Apr 2020

The number of patients with rare diseases in Europe is increasing every year. However, less than five percent of those living with a rare condition have access to an EU-approved therapy, while inequalities in access persist between and within countries.

We are also starting to feel the consequences of an ageing population, such as increased healthcare costs that are placing a growing burden on Member States’ health budgets.

Considering that most countries have been shrinking their public healthcare systems for decades, they may be unable to face what is coming.


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Unfortunately, this development creates unrealistic expectations of what the EU can do. Especially as the EU legal framework cannot address unequal access to medicine; we can only make cosmetic changes. Unfortunately, this debate remains a political one and sits only at national level.

This has to change. It seems to me that Member States are unwilling to harmonise their different health systems more and transfer at least some of their powers to the EU institutions in this area. Without this, we cannot move forward.

We are seeing more and more medicine shortages across Europe. A staggering 99 percent of EU pharmacists say they have experienced it, while 63 percent report that they continue to on a weekly or even daily basis.

“The EU legal framework cannot address unequal access to medicine; we can only make cosmetic changes”

Medicines that become unavailable are often substituted with less effective, inferior or more expensive alternatives.

The ENVI committee is now preparing a resolution on this issue, for which I am the shadow rapporteur.

There are numerous causes of shortages, like medical, regulatory, economic or Republic, for example, we are desperately trying to solve the problem of the so-called parallel re-export of medicine.

In Germany, health insurance companies are encouraging pharmacies to replace prescribed medicinal products with imports of the same product from other countries at a lower price.

The result is that these irreplaceable medicines are then unavailable to patients in the exporting country. Germany has begun depleting medicine stocks in the countries that have the lowest prices – often a result of having lower living standards.

However, if a Member State tries to block this practice, the Commission can launch infringement proceedings because the medicine is still treated as a commodity.

Member States should reach agreements based on solidarity and fairness, and they should restrict parallel trade from poorer to richer countries where it threatens the local population’s supply.

“We have to consider the impact of the current COVID-19 crisis, which shows us that cooperation at EU level on public health issues is not working”

They should also prioritise the interests of patients and public health over the internal market and take action to limit the negative impacts of parallel trade, where necessary, on grounds of public health.

I think it is time that we start considering medicines as not just another normal good, and therefore the definition of a good in the sense of the free movement of goods must be amended.

Moreover, Cohesion Policy could also soften this issue, if there are enough resources. However, under the status quo of the EU’s primary legal framework relating to health and the lack of financial resources, we cannot expect significant improvement.

For example, we cannot even add economic criteria into the joint health technology assessment (HTA) because we are prevented from doing so by the wording of the Treaty on the Functioning of the European Union.

Pricing and reimbursement authorities should be transparent about their decisions: how these are made, what criteria are used and who is involved in the process.

Unfortunately, this is not common practice. What we can probably do is cooperate more on joint purchases of medicines between Member States.

We can see a good example of this practice in the Benelux countries, where the three Member States are jointly negotiating the purchase of remedies for rare diseases with pharmaceutical groups.

So far, the group has only been successful in completing formal joint negotiations for the purchase of Biogen’s Spinraza - a medication used for treating spinal muscular atrophy.

According to available information, this group has negotiated a significant reduction in the price of this drug. This means more affordable medicines for patients and huge budgetary savings for governments.

We are also trying the same approach with the Visegrad group, although joint purchases have so far failed due mainly to the lack of a common HTA and the differences between our national health systems.

For example, in one Member State, the drugs for hospitals are directly bought by the Ministry of health, while, in other Member States, those medicines are bought by the hospitals. It is clear in this situation that joint purchases are not possible, and this is the core of the problem.

We should focus on what is possible under the existing legal framework, while also limiting the expectation of our citizens of what the EU can do to address this problem, since, without significant constitutional changes, further steps will not be possible.

Last, but not least, we have to consider the impact of the current COVID-19 crisis, which shows us that cooperation at EU level on public health issues is not working.

After we overcome this crisis, we have to think about how we can redesign this system. We have to see this situation as the opportunity to improve.