It is ultimately my responsibility within the company to ensure European patients can receive the medicines we launch as quickly as possible. On this dashboard I wait to see each country turn green. Green to signify the medicine is not only approved but also available to patients. This can only happen following successful completion of the reimbursement process in each Member State.
Indeed, I feel these expectations if we are not meeting our aspirations to have patients access medicines as rapidly as possible. Where you live in Europe can determine your ability to access a treatment, and that is understandably concerning.
In this, at AbbVie, we absolutely share the European Commission’s ambition, contained in the proposed revision of EU pharmaceutical legislation, to address unequal patient access across countries. Years of research do not fulfil their full potential if the medical outputs remain out of reach.
But the current proposals provide the wrong treatment to the root causes of this issue. At this stage, the reform penalises pharmaceutical manufacturers for something that is outside of our control to deliver, challenging ongoing European predictability and undermining private investment.
There is an alternative, more realistic, solution building on a commitment from manufacturers like AbbVie to go further. But first, let us consider the shared challenge.
The end goal – patient access to medicine
A case from Belgium, where I worked earlier in my career, provides one example to illustrate the complexity of this challenge.
Rhea is a Belgian patient (a real case but a different name). After the shock of her diagnosis of chronic lymphocytic leukemia, a cancer that can ultimately be fatal, Rhea’s body was unable to fight the relentless multiplication of white blood cells, her lymph nodes were swollen to the size of tennis balls and she felt her health slipping away.
Her doctor suggested a new treatment, available at that time in Germany, Spain and Greece, but not yet in Belgium. She nevertheless obtained it through a special research access program.
The intervention worked, and today, three years after this treatment, Rhea is in remission and no longer takes any medication.
Long before Rhea’s doctor could consider this medicine, the journey began with painstaking research: thousands of molecular compounds tested with the goal of finding the one to make the difference. On average, only one out of 10,000 tested has any potential.
Additional years of clinical trials and testing took place until it finally secured EMA approval. It is after this that our challenge of variable access really began, as pricing and reimbursement processes (meaning getting to the point when the medicine is made routinely available to patients within any particular country) got underway.
This is the dashboard I look at every day.
Reimbursement is a national responsibility of each Member State. Demographics, healthcare infrastructure, and patient pathways established over decades all contribute to the different processes that now exist, with the patient as the final destination.
In the example above – which while taken from Belgium ultimately occurs in many countries highlighting this complexity – the national approval of the medicine Rhea benefited from took 1,310 days.
One step forward, two steps back
The current Commission proposals would treat this challenge by reducing the current regulatory data protection that pharmaceutical manufacturers obtain when launching a medicine – a critical provision that underpins the significant investments needed in medicine development – unless they manage to conclude these access procedures with all Member States within two years of EMA approval.
At a time when Europe needs to become more, not less, competitive in medical research on the international stage, this approach penalises a company unless it can navigate and achieve 27 successful Member State reimbursement outcomes. It ignores the reality that access is a discussion that involves many different decision-makers.