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Highlights

Active Citizenship Network, promotes this multi-stakeholder event since 2007, and as its Director, I am so honored to have celebrated this relevant anniversary at the European Economic and Social Committee.

On this 10 of May 2017 there were with us leaders of civic and patient organisations and relevant stakeholders coming from at least 17 Countries, some of them outside the European Union, such us Albania, and others even from other continents, such us Canada.  Moreover, there were representatives and leaders of 22 international and European networks, professionals and experts, public and private bodies and providers, public relation agencies and other relevant stakeholders.

The European Patients’ Rights Day was established in 2007 to underline the relevance of the patients’ rights across Europe, as stated in the European Charter of Patients’ Rights, which was drafted in 2002.

As suggested by the title of the event “European & National Medicines Regulatory Systems:
challenges for an equitable, timely and suitable access to innovation”,
last 10 of May’s conference focused on the patient’s right of access “every individual has the right of access to the health services that his or her health needs require. The health services must guarantee equal access to everyone, without discriminating on the basis of financial resources, place of residence, kind of illness or time of access to services”, and on the patient’s right to innovation “each individual has the right of access to innovative procedures, including diagnostic procedures, according to international standards and independently of economic or financial considerations”.

The topic of the day has been chosen in compliance with the last two editions of the European Patients' Rights Day, both dedicated to sustainability of the European healthcare systems, which still represents a major challenge for governments, healthcare providers and patients.

We are aware that the regulatory world (and others as well) is facing some formidable, but at the same time extraordinarily stimulating scenarios in trying to solve one of the greatest challenges of the modern age: the future of sustainable innovation. The world of health care is revolutionised by new, increasingly personalised treatment options, in some cases at extremely high costs: for instance, trying to fight  hepatitis C and cancers. In the second session of the conference, some case histories about that has been shared.

Accessibility to medicines, in particular to innovative medicines, is becoming increasingly urgent as it is recognised as a fundamental right, promoted as a common EU policy. Across Europe, there is a common need for a comprehensive review of drug policies. New ways to provide people with the care they need should be identified. To achieve this, we need strategies shared globally, introducing, for example, new models of interaction between regulators, payers, health professionals, companies, advocacy patient groups and civic organisations: without this, the risk is the financial collapse of the systems, first at national level, then at EU level.

Promoting, evaluating and supporting healthcare innovation is a key issue: it is ultimately the condition on which depends access to safer, more effective therapies, and therefore better treatment opportunities and better quality of life for patients.

In this context, the aim of the convention was to discuss, inform and suggest new approaches to the existing European and National Medicines Regulatory Systems, for a better management of access to innovation. Indeed, access to innovative therapies strongly contributes to define the quality of life of patients and the quality of healthcare services provided, respecting the fundamental values recognised by the already mentioned European Charter of Patients’ Rights.

The Council conclusions on Innovation for the benefit of patients during the European semester of the Italian Presidency (December 2014) recognised that “innovation in healthcare can contribute to health and well-being of citizens and patients through access to innovative products, services and treatments that have added value with regard to the existing ones. It can also lead to more effective ways to organise, manage and monitor work within the health sector as well as to improve the working conditions for healthcare staff”. Nevertheless, for example, in many European countries patients still have to wait a long period of time before the medicines – although already approved by the European Commission – are available. The European legislation has provided many tools to facilitate the early availability of therapies. However, in many cases long national procedures for reimbursement can delay this availability. Unacceptable disparities in patients’ access – due to different pricing models, authorisation times, information accessibility, channels and criteria of distribution, etc. – in particular with regard to innovative medicines, persist, and they have been made even worse by the adoption of austerity measures and by the reduction of healthcare spending in many Member States since 2009.

European and National Regulatory Authorities and Institutions, patient Organisations and Companies should work together to overcome the increasing number of barriers and inequalities.
In this context, the first steps should concern a clear and shared definition of innovation, but also current procedures – and their transparency – for authorisation, pricing and reimbursement, and to bridge the gap caused by the lack both of information and of patient involvement in these processes.
Indeed, despite their differences, each National Health System in the EU should guarantee the same rights to patients and people in general.

We need to come to grips with the new pharmacological treatments, often much more expensive, and with patient’s right to timely access to safer and more effective drugs. The panelists has been thus invited to share their point of view on that, according the following main issues:

  • how to balance the pharmaceutical innovation with an adequate responses to population’s legitimate demand for healthcare?
  • Highlighting the need to harmonise drug policies, how to address and implement the European Commission recommendations, taking into account the interrelationships that are inevitable, in a unified global market, between the policies of the different EU and non-EU countries?
  • At national level, what about new, more flexible approval models - already adopted at European level - since the procedures are becoming more and more centralised and patient populations increasingly stratified?
  • Is it feasible for the national medicines agencies to recognise a more active role of advocacy patient groups and civic organisations during both the authorisation and the negotiation phases? Months ago, Active Citizenship Network conducted a survey to know if and how patient representatives and associations are officially involved in the decision-making processes within their national medicine agencies. The answers from 20 EU Countries showed that 10 are involved in the process, while 10 are not involved instead. For this reason, in the third part of the conference, we putted together Representatives of National Medicines Agencies and Patient Associations from countries with and without an official patients’ committee in the National Medicines Agency to exchange experiences and learn from each other the best way to (re)act.

From the conference, I did not expect to find solutions! I did expect an open debate with no misconceptions, and concrete actions to follow up this initiative. The key messages, recommendations and next steps emerged

Thank you!
MarianoVotta
Director Active Citizenship Network

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