"Good morning Ladies and Gentlemen,
Please allow me to start my speech by expressing my deep condolences to the French Government and Nation as well as to the two representatives of France who unfortunately, due to the recent events in Paris and especially the ones in Saint-Denis yesterday morning will not be able to be with us today. All of us are deeply shocked and in mourning after the terrorist attacks in Paris.
It is an attack against our common values.
Today we stand united with the French people and the Government of France.
Ladies and Gentlemen,
I would like to warmly welcome you to Luxembourg for the meeting of EMACOLEX during the Luxembourgish Presidency.
And I am all the more delighted to be doing so as this year we are celebrating the 50th Anniversary of the pharmaceutical legislation and the 20th Anniversary of European Medicines Agency. I am especially grateful to the tireless efforts of legal officials thanks to which the EU may pretend to have one of the most comprehensive legislation in the world with the highest standards of quality and safety of medicinal products.
The pharmaceutical legislation touches upon a wide range of domains such as clinical trials, transparency aspects in relation to reimbursement and pricing, intellectual property rights or qualifications of health professionals. Some of the actions carried out in this field fall within competences which are shared between the Union and Member States, while other measures aim only to support, coordinate or supplement the actions of Members States without superseding their competence in these areas.
This is all the more true as the European pharmaceutical legislation builds upon a double Treaty legal basis. Indeed the EU legal regime on medicines follows at the same time the rules governing in the internal market and those governing public health. This requires some sensitive balancing between free movement of goods and the protection of human health.
The complexity and variety of medicinal products and the rapid development of new technologies in the pharmaceutical sector necessitate a harmonised approach among Member States while ensuring a flexible environment for regulators adopting tailor-made decisions.
Meetings like the EMACOLEX meeting contribute to reaching this balance.
They create the opportunity to share issues and learn from best practices at EU level. My hope for this meeting in Luxembourg is that we will move forward collectively with some challenging questions around pharmaceutical legislation, questions that need to be looked at closely if we want to ensure that safe, effective and high quality medicines will quickly be made available to all citizens across the EU.
You will address today and tomorrow legal issues related to parallel import, orphan drugs and medicines prepared in a pharmacy. You will also explore current trends in the new veterinary legislative package and reflect on the work done by the Commission Expert Group on Safe and Timely Access to Medicines for Patients.
I would like to thank the Dutch Medicines Evaluation Board who has worked tirelessly together with my services to deliver this meeting under the Luxembourgish Presidency.
Dear Ladies and Gentlemen,
I couldn’t possibly give an opening speech of this nature without referring to the priorities of the Luxembourgish Presidency in the field of public health.
In July Luxembourg Presidency started the health part with a debate in early July on a subject which is very dear to me: personalised medicine. The conference allowed to generate a cross-sectoral and lively debate on how to tackle the obstacles to the integration of personalized medicine into clinical practice, focused around the public health perspective and related needs of patients. This issue requires some sensitive balancing between the need to provide new targeted technologies to our citizens and the need to improve the sustainability of our healthcare systems. The Presidency has integrated the main messages of this Conference into Council Conclusions whose adoption revealed to be quite challenging. This confirmed me in the belief that Personalised Medicine is a challenging issue indeed and that it needs further discussions at EU level.
The Conference on personalized medicine was followed in September by the Informal Health Council. It focused on:
- secondary prevention of dementia and the role of post-diagnostic support. Dementia is among the diseases where new treatments are absolutely needed as an ever bigger part of our ageing population is concerned by dementia.
- the role of health in the European semester
- the application of patients’ rights in cross-border healthcare two years after the transposition deadline of the directive;
and on migration and health, in particular on the need for a solid, responsible migration policy addressing all the dimensions of this crisis and respecting our common values. A month ago a high-level conference on Ebola focused on lessons to be learned to improve preparedness and response in the EU for future outbreaks. The vital role of further research on the treatment and the vaccination against this epidemic were along the many messages retained.
Among other priorities I will quote the revision of the veterinary medicines legislation and of the medical devices legislation. We have invested an considerable work in these two files and we will put into place everything needed to make as much progress as possible.
Ladies and Gentlemen,
Making rapidly available on the market truly innovative safe, effective and high quality medicines is a real challenge. The speed does not go naturally with quality I need to admit. But “Innovation for the benefit of patients” is a motto I can easily subscribe to.
Indeed the Luxembourgish Presidency follows the leitmotif of "A Union for the citizens" which means that “European citizens are at the heart of the European project”. In terms of public health, patients and innovation will be at the core of discussions, which should be driven by a concern with issues of values and ethics.
In the context of the trio presidencies programme, a discussion was initiated on how to make effective use of the existing EU regulatory tools such as (1) accelerated assessment, (2) conditional marketing authorisation and (3) authorisation in exceptional circumstances. Shorten the assessment of the medicinal product while in the same time ensuring the high level of patient safety may indeed provide the expected benefit.
As you work through your discussions, it is important to remember that the sharing of new experiences gathered from around Europe will help and has, helped us all to look to the future of the health care provision related to medicinal products.
We have to continue to find ways to build on progress, to continue to push boundaries and to work together to meet the real challenges that face us all.
This meeting will make a valuable contribution to that and I am sure you will have a very productive time in Luxembourg.
Thank you so much for your attention!"