Luxembourg EU Presidency to champion access to breakthrough therapies

“Many challenges need to be overcome,” in terms of access for patients to personalised medicine in Europe, said Luxembourg’s Minister for Health in Brussels this week. Speaking at a high-level, two-day conference on personalised medicine, Minister Lydia Mutsch (pictured) also called for “a patient-centred strategy involving EU decision makers and regulators in the area of public health”.

At the conference, hosted by the Brussels-based European Alliance for Personalised Medicine (EAPM), the minister told attendees that: “Personalised medicine will be a thematic focus of the Luxembourgish presidency,” which will “highlight opportunities to accelerate progress”.

She added: “Personalised medicine starts with the patient. It has enormous potential for improving the health of many patients and ensuring better outcomes. Yet, its integration into clinical practice and daily care is proving difficult given the many barriers and challenges to timely access to targeted healthcare that still exist as of today.

“The time has come to formulate a patient-centred strategy involving EU decision makers and regulators in the area of public health, to enable EU and Member States to contribute to integrating personalised medicine into clinical practice while enabling much-greater access for patients.”

The minister also called for “incentives at national and EU-level, as well as co-operation between member states”. These are vital, she said, “to make early access to personalised medicine a reality for patients throughout Europe”.

The conference heard that the importance of access to medicines and innovative treatments for Europe’s patients is undergoing particular scrutiny at the moment. Indeed, delegates were told, the European Parliament held a discussion earlier this year on access to medicines, following a statement by the Council and the Commission.Stanimir Hasurdjiev, Board Member of the European Patient Forum and the Patient Access Partnership emphasized that more and more patients’ groups and individual citizens are becoming aware of the potential of personalised medicine, with its ability to give them the right treatment at the right time.

He said that patients want empowerment, they want to have their illnesses and the treatment options explained in a transparent, understandable manner (from a clinician with up-to-date knowledge) to allow them to become involved in co-decision, and, crucially, they want greater access to treatments that could improve their lives and, in some cases, save them.

Latvia’s Zanda Kalniņa-Lukaševica, president-in-office of the Council, has already stated during the country’s own Presidency (which runs until the end of this month) that “access for patients to medicines that efficiently treat illness is an important issue that must be addressed both at national and EU level”.And earlier this year, the European Commission set up the Expert Group on Safe and Timely Access to Medicines for Patients, known as STAMP. STAMP began its work in January but, while the conference was told that EAPM welcomes the initiative, it maintains that it is not enough.MEP Cristian-Silviu Bușoi said that “despite the existence of innovative new drugs, new technologies and developments in medical science, many citizens are not able to access them, often due to high costs. Other issues include overly bureaucratic reimbursement procedures and a lack of implementation of the Cross-Border Health Care Directive.”

Bușoi added that EU policymakers should ensure that regulatory decisions on the value of innovative therapies are based on what matters most to patients, and ensure that they get access to innovative treatments following a centralised cost-benefit analysis by the EMA.

MEP Andrey kovatchev added that in a 500 million citizen-strong EU of 28 member states with an aging population that will inevitably become ill at some stage, giving patients access to the best possible treatment available in Europe is a massive issue.

Indeed, the importance of access to medicines and innovative treatments is undergoing particular scrutiny at the moment and is currently a big issue in the European institutions.The conference also heard about the growing proportion of new drug approvals that are personalized medicines. 20% of the 44 novel new medicines approved by the FDA in 2014 had included reference to specific biological markers, identified by diagnostic tools that help guide decisions and/or procedures for the product’s use in individual patients.

Reflecting on the development, Ansgar Hebborn, co-chair of EAPM’s Working Group on Access, and head of Global HTA & Payment Policy at Roche Pharmaceuticals, said: “The rapidly growing number of new personalized medicines demonstrates the progress that has been made in advancing the field from an visionary idea 20 years ago to an established approach to treating many diseases today.”

Hebborn added: “Getting novel medicines and treatments, to patients that could truly benefit must be a top priority. The ability to sustainably differentiate medicine prices between higher and lower income EU member states is a critical aspect towards more equitable and affordable patient access across Europe.”  Access for patients was debated by a high-level panel at the two-day EAPM conference in a plenary entitled ‘Overcoming barriers to access and understanding value: Patient access to innovative therapies’.

The panel included Breda Flood, president of the European Federation of Allergy and Airways Diseases Patients’ Associations and Luis Mendao, from the European AIDS Treatment Group. Delegates also heard that delays in access and inequalities in access to new treatments in different member states often had an impact on the economy, due to people being unable to work, an impact on the patient’s family, as well as the obvious negative impact on the citizen unable to get access. There is a need, the conference heard, for common action within those member states through collaboration. The conference was also addressed by Latvia’s Secretary of State for Health, a Maltese government health representative, and several cross-party members of the European Parliament, as well as representatives from relevant European Commission DGs.

These were joined by senior figures from across EAPM’s broad base of stakeholders ranging from academia, through research, to industry, policymakers and patient groupss

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