"Thank you Gordon,
Good afternoon.
First of all let me say how pleased I am to be here at the third annual conference of the European Alliance for Personalised Medicine.
As you know, my country takes over the EU’s rotating presidency in a few weeks from our colleagues in Latvia. What you may not know is that personalised medicine will be a thematic focus of that presidency and discussion of the topics will get underway with a high-level conference on 8 July. This will involve all stakeholders including many connected with EAPM.
The Luxembourgish Presidency has made Personalised Medicine one of its health policy priorities.
I firmly believe that by taking stock of where we are in Europe in terms of access to personalised medicine, acknowledging challenges need to be overcome.
The Luxembourg Presidency will highlight opportunities to accelerate progress. In this regard, incentives on national and EU-level as well as cooperation between Member States are vital to make early access to Personalised Medicine a reality for patients throughout Europe.
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.
We believe that 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.
In order to provide a clear focus and to devote sufficient space to analysis, discussions during the conference will concentrate on how:
- to assess and address obstacles to the integration of Personalised Medicine into Europe’s healthcare systems
- to identify best practices and their added value
- to outline the potential benefits of Personalised Medicine on public health and its impact on policymaking in the EU
The conference’s main findings will feed into Council Conclusions to be adopted by the 28 health ministers during the Council of Health ministers on 8 December 2015.
Attendees will be drawn from key stakeholders whose interaction will create a cross-sectoral, highly relevant and dynamic discussion forum.
These participants will include public health decision makers, representatives from the Commission, Members of the European Parliament, patient organisations, and European umbrella organizations representing interest groups and associations actively engaged in the field of Personalised Medicine.
The exciting field of personalised medicine is, and should be, all about the patients. It offers the opportunity for them to be seen not merely as passive recipients of care but as participants, partners and even experts in their own healthcare.
Involving patients in treatment-related decision making is in line with the increasing acknowledgement of their right to autonomy and self-determination. For personalised medicine to reach its full potential, it needs engaged and informed patients who are empowered, who are informed about their health risks, illnesses and treatment options in an understandable way, who are encouraged to discuss their treatment options and their possible consequences, hence who can forge an informed decision about the best action to take for their health, in their personal context and preferences.
Success for personalised medicine as a whole will require higher levels of health literacy among patients and the wider population. There is also a clear need for updated skills among healthcare professionals – a subject you will hear more about tomorrow. This will allow our front-line professionals to engage more closely with patients over personalised prevention, treatment issues, and options. We recognise that investment in education and training of clinicians and health professionals is needed to achieve this.
In Luxembourg, we aim at enhancing and strengthening the relation between the patient and his or her so-called "Médecin Référent", or trusted doctor, or preferred doctor, whose missions involve coordinating care, helping the patient navigate the health system and making choices about prevention and treatment strategies. Launched in 2012, the "Médecin référent" is dedicated to become an important tool to tackle chronic diseases. It is also the suitable element to funnel and deliver information about Personalised Medicine to the ones who need it most, patient and clinicians.
Education and information is also crucial as the arrival of Big Data has marked a new moment for health care. Clearly, the advancement of personalised medicine can only occur if easier use and circulation of personal health data is allowed for scientific research purposes and clinical benefits, with, of course, appropriate protection of private data.
If we want to achieve progress and integrate Personalised medicine into clinical practice, it will be necessary to regulate circulating and sharing of personal health data with a wide range of data experts and medical specialists. While working together, they can derive the most appropriate interpretation from the data and extend it to others.
We must engage all stakeholders - especially patients, research participants, healthcare professionals and the public - on how to obtain the best balance between these conflicting priorities of data sharing and data privacy.
In Luxembourg, we have succeeded in addressing this challenge very recently with the so-called "dossier de soins partagés" or "shared health file". This new electronic tool allowing for the sharing of personal health and medical data was launched on 11 May this year. This secure electronic health record is under the direct control of the patient, who decides alone what information goes into it and who is allowed to access it. He or she is able to see at all times who accessed his or her record and for what reasons. He or she can decide to close the record any time. This tool, currently involving a sample of patients, clinicians and health professionals, is serving as a pilot to pave the way to the enactment of its detailed specifications, in a very pragmatic and responsive approach. This is an excellent example of a measure allowing people to become active participants in their own health care.
The national "Dossier de Soins Partages" is also one of Luxembourg strategy to break the "silos" in which health and medical data are currently stored and move forward to an enhanced capacity to use data, interdisciplinary and intersectorialy.
But Luxembourg has also been very active in other fields relating to Personalised Medicine.
1) One major best practice example is the Personalised Medicine Consortium (PMC), an umbrella organisation which serves to coordinate activities between groups, encouraging information-sharing and avoiding the duplication of activity. The PMC regroups the Integrated Biobank Luxembourg, the Luxembourg Centre for Systems Biomedicine and the Lung Cancer Project.
The PMC also devises programmes in research that will help to make Luxembourg a world leader in the adoption of personalised medicine into the national healthcare system. Its initial areas of focus include cancer (lung, colon, and breast), diabetes, and Parkinson’s Disease. The PMC is keen to build new collaborations between clinicians and researchers from Luxembourg and to foster new synergies. To aid in this process, the PMC has developed since 2014 a PMC FUND to "pump prime" new initiatives.
The expectation is that the funding will be used to initiate new collaborative research projects on biomedical research between clinicians and researchers who have not previously worked together and who are based in different research institutions. Priority will be given to projects that are innovative, that are establishing new collaborations within Luxembourg.
The main expected return on investment of such funding relies on:
- Solving unmet clinical needs with innovative approach
- Fostering research interactions between the 3 biomedical research institutes of Luxembourg
- Enabling researchers/clinicians to develop this project into an externally funding project if successful
Since 2011, the PMC organises an annual retreat for its members to discuss the progress of current personalised medicine research projects and establish new interdisciplinary collaborations.
2) Today and tomorrow, discussions will also touch upon biomarkers. Luxembourg has also to offer expertise in this field: The IBBL (Integrated BioBank Luxembourg) is a biobank dedicated to support biomedical research for the benefits of patients.
Created in 2008, IBBL plays a central role in the Action Plan’s goal of developing Luxembourg as a centre of excellence in biomedical research, and bringing personalised medicine to its people.
IBBL is more than a traditional biobank: it has built an integrated infrastructure. Not only does IBBL collect and store biological samples and their associated data, making them available to research organisations studying human diseases, it also aids in sample analysis and the provision of technologies and research. IBBL is committed to maintaining high standards of quality of data and samples, meeting the highest standards of medical ethics, and ensuring the rigorous privacy of the data that is collected.
3) Luxembourg is also very active on the integration of Personalised Medicine in the field of cancer treatment – a subject that will be addressed tomorrow at this Conference.
Our recent national cancer plan (2014-2018) fosters regular exchange between researchers and clinicians in order to allow better and more personalised treatment of the cancer patient.
Personalised information of the patient is also one of the major pillars of this plan.
The plan is articulated around 10 actions which will boost cancer research in Luxembourg and guarantee an intersectorial approach between all the actors concerned.
Coming back more generally to the issue of Personalised Medicine – let me just underline a few other points which I consider to be most important and that I would like to be addressed during the Luxembourg Presidency:
- The voice of the patient: the role of patients as regards empowerment, shared decision making, their consent and the protection of their private data.
- health technology assessment: the future development of personalised medicines requires developments in health technology assessment that will support timely patient access. Effective evaluation of the medical, social, economic and ethical issues of products in a systematic manner will promote safe, effective, health policies that are patient-focused and obtain best value.
- Paying for Personalised Medicine : There are wide divergences in national regulatory systems, and many countries do not require regulatory approval for reimbursement - thus disadvantaging or discouraging the search for clinical evidence. We need to promote the acceptance of innovative payer models based on patient relevant outcomes and of added value offered by PM, rather than based on overall healthcare spending
- Training of healthcare professionals: healthcare professionals will need to adapt to new ways of approaching patients, new patient needs and new health technologies requires suitable training. They need to develop communication skills with patients to allow for an informed choice and shared decision making. They need to learn how to interact with various professionals involved in the treatment.
- Public-private partnerships: it is Luxembourg’s view – and one that I am sure is shared by you all – that public-private partnerships, such as IMI, are vital in supporting pioneering research.
- Public-private partnerships can drive forward personalised medicine research, benefiting from wide expertise and input, and knowledge that can be rapidly exploited by all key groups.
All of these topics will be addressed in depth during - what I am certain - will be a highly successful and productive conference in July in Luxembourg.
I am sure that the result of the Conference of today and tomorrow will feed in nicely into the Presidency Conference and that both events will mark a new moment in the promotion of Personalised Medicine.
Once again, let me tell you that I am very pleased to be here, especially with such a distinguished audience of stakeholders from the European Alliance for Personalised Medicine who, I am sure, will be collaborators in pushing forward the personalised medicine agenda for the benefit of all of Europe’s patients, now and into the future.
Thank you."