The EU has moved forward with personalised medicine - so more of the same in 2015, please

Opinion by European Alliance for Personalised Medicine (EAPM) Executive Director Denis Horgan

In the arena of health care, and specifically personalised medicine, it can be argued that the European Union in general has had a pretty good 2014.

The Commission, Parliament and Council has combined to move new legislation along nicely while taking on board the views of various stakeholders – most notably patients (through the EMA), as well as those who make up the European Alliance for Peronalised Medicine (EAPM). We congratulate the powers-that-be for keeping their eyes and ears open and long may that continue to be the case.

Great progress has been made in the huge areas of the Clinical Trials Directive, Data Protection Regulation (DPR), Big Data issues, and the legislation on In Vitro Diagnostics, or IVDs.

Meanwhile, Horizon 2020 rolls on, the Innovative Medicines Initiative second phase (IMI II) is now under way and even the Commission’s new Semester process could aid health care systems if used wisely and in a forward-thinking manner, allowing opportunities for investment, training, research and focusing on sustainability.

With personalised medicine, we are on the cusp of a revolution in health care. But whether we can support innovation – and afford it – will depend on how smart health systems are at allocating resources in the right way. The Semester process should take this into account.

Another important development from 2014 could be Commission President Jean-Claude Juncker’s ambitious European Fund for Strategic Investments, which aims to ‘kick-start’ Europe by raising €315 billion over three years. This will be jointly funded by private investors (€252 billion) and guaranteed public money from the EU budget and the European Investment Bank.

So, a good and very busy year. The clinical trial regulation was published in the official journal of the EU in May, while the Spring of 2014 also saw the European Parliament vote on the EU proposal for a DPR, which will set the rules for handling personal data in member states.

But the work is not yet all done and must continue in the New Year. For example, EAPM believes that the Data Protection Regulation should permit the primary and secondary use of data for health research purposes bearing in mind the safeguards already in place across the EU. Meanwhile, clinical trials improvements should not be undone by the data regulation.

On top of this, the revision of the IVD Directive presents an opportunity for strengthening the current approval system for IVDs for the sake of patient safety, competitiveness and innovation. But a five-year transition period is needed for manufacturers to be able to fully comply with various new requirements.

Not to be forgotten is the fact that, in the changing world of health care in Europe, a key element is the education of health-care professionals. The true potential of all of the new science, built around genetic profiling and individual DNA, will never be fully realized unless the front-line clinicians have the knowledge and understanding to exploit it. The EU needs to make moves in this sphere and the Alliance has called for urgent action.

EAPM’s work, including countless meetings with policymakers and legislators, its four Working Groups (covering Big Data, Education and Training of Health Care Professionals, Early Access and Better Decision Making, Research Road Map for Personalised Medicine plus a Regulatory Affairs Task Force), and its STEPs Interest Group of 15 cross-party MEPs, is paying dividends in the drive to provide personalised medicine for all of Europe’s 500 million citizens across 28 Member States.

But, as stated above, more needs to be done. For example, the Alliance strongly hopes that, in 2015 and beyond, the EU will follow the recommendations of its Working Groups, plus the STEPs Interest Group.

STEPs, incidentally, stands for Specialised Treatment for Europe’s Patients and the campaign calls for the Union to commit to:

• STEP 1: Ensuring a regulatory environment that allows early patient access to novel and efficacious personalised medicine.

• STEP 2: Increasing R&D for personalised medicine, while also recognizing its value.

• STEP 3: Improving the education and training of health care professionals.

• STEP 4: Supporting new approaches to reimbursement and HTA, required for patient access to personalised medicine.

• STEP 5: Increasing awareness and understanding of personalised medicine.

In addition, in 2015, the European Union will have two of the smaller member states as its rotating presidencies: Latvia and Luxembourg. Europe’s health policies need to recognize and tackle the inherent health system vulnerabilities faced, specifically, by smaller countries and in the regions of the larger ones. EAPM therefore calls for a SMART approach – 'Smaller Member states And Regions Together'.

And patients are calling for the same: Elke is a 24-year-old Austrian with a rare cancer. She said: “Although my country is not particularly large, I still find it hard to discover information about clinical trials. Even so, my cancer is so rare that I would probably have to travel to another country at a high cost of money and time.”

In the north of England, meanwhile, Samantha – aged 53 – said: “I am a great believer in personalised medicine and, one day, would like to run my full DNA. Hopefully, by the time I need it, the health services will have caught up and will understand all this wonderful new technology.”

And 37-year-old Mario in Rome told EAPM that his idea of a Happy New Year is that his twin, teenage daughters can, if necessary, be assured of the right treatment at the right time if they ever develop breast cancer as their mother did.

Such stories are commonplace, but the future is bright for personalised medicine and the Alliance welcomes the EU’s hard work. We hope and expect the Commission, Parliament and Council to remain committed to promoting personalised medicine and its effective implementation, in order to help drastically improve the health options of the EU’s 500 million citizens across 28 member states.

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