Personalised Medicines: How Can Policy Make It Happen For Patients?

You may have noticed that personalised medicines has bounced to the top of the EU health policy agenda of late. This past month alone has seen high level discussions on how best to leverage their potential here in Europe, from the European Alliance for Personalised Medicines (EAPM)'s annual conference to the Luxembourg Presidency conference earlier this week. Why the focus on personalised medicines right now?

This can be explained by the policy question at the heart of personalised medicines: their potential for increasing and extending access to high quality health care is clear but how to make that happen is not. This is why the Luxembourg Presidency decided to devote a day to answer the following question “How to make access to Personalised Medicine a reality for a larger amount of citizens and contribute to integrating Personalised Medicine into clinical practice?”

Despite the potential personalised medicines can bring to improving health outcomes for patients, the integration and uptake of these medicines across Europe’s health systems is low. Reasons vary: at which point of a patient’s journey should a personalised (also known as stratified or targeted) medicine be used? Is there a diagnostic tool to identify which patients will benefit from it? How can a healthcare system balance the imperatives of universal access to care and financial limitations? There are no easy answers. As one of our guest bloggers, Denis Horgan, Executive Director of the EU Alliance for Personalised Medicines, put it, facilitating the introduction of personalised medicine in Europe’s health care systems “cannot be done without many shifts in mindset”.

Many healthcare systems in Europe today are built on the principle of offering access to a ‘package’ of care for the largest possible audience. Focusing therefore on the tailored response for a single patient may seem counter-intuitive. But its applications could revolutionise prevention and treatment. What is needed can be summarised in three points:

  • Health literacy and patient engagement: personalised medicine is about the characteristics of an individual patient. It’s therefore essential that the patient voice is central to decision-making.
  • A regulatory, reimbursement and HTA environment which allows early and flexible patient access to novel and effective personalised medicine.
  • An approach to healthcare that looks at the health continuum from prevention, to diagnosis and treatment of each individual in a tailored manner, rather than a population-based approach.

There is good reason to be hopeful. Innovation exists to offer more tailored interventions for the diagnosis and treatment of patients, and policymakers are keen to capitalise on it. The Luxembourg Presidency will be working towards conclusions that are to be adopted by the 28 health ministers during the Council on the 8th of December 2015. As Health & Food Safety Commissioner Vytenis Andriukaitis put it speaking in Luxembourg this week: “The stratification of the population is one of the answers on how to calculate the future costs to make sure that the scientific innovation finds its righteous place. Clearly, there are many challenges and right balance needs to be struck.”