On Tuesday, 22^nd March 2011, the launch of the Melanoma Independent Community Advisory Board (M-ICAB) marked a historic moment in cancer advocacy, and in particular melanoma. Stakeholders and members of the melanoma community gathered to identify and adopt concrete actions to improve the situation for melanoma patients. The event was hosted by ECPC and moderated by Prof. Patricia Garcia Prieto, founding member of M-ICAB and stage IV melanoma patient. The M-ICAB initiative was inspired by her battle for access to treatment and to clinical trials.

Participants in the interactive workshop included representatives from pharmaceutical companies, academic researchers, practising clinicians, MEPs, representatives from the European Commission and from the regulatory body the European Medicines Agency, as well as patients, relatives, carers and advocates. This is the first time other stakeholders have been invited by patients to an event where patients shape the agenda. M-ICAB offers a new model of connectivity to improve communication between stakeholders and to ensure a patient-centred approach at all times.

The conference was launched by Sandra Craine, chair of ECPC’s Rare Cancer Action Group, who explained the purpose of the Independent Community Advisory Board structure and ECPC’s goal of establishing ICABs to address other disease communities. A series of presentations then followed.

Prof. Véronique del Marmol, Chair of Euromelanoma and head of the Dermatology Department at Université Libre de Bruxelles (Belgium), gave a presentation on the importance of education and awareness for catching melanoma early. This includes education of the general public, as melanoma is usually diagnosed after the patient identifies something unusual, but also for healthcare professionals such as nurses and general practitioners, as direct access to a dermatologist is not possible in many countries and training often does not include diagnosis of melanoma. This is reflected in the number of misdiagnosis litigation cases in some European countries.

Prof. del Marmol compared incidence and mortality of melanoma across European countries, showing that incidence was much higher in northern countries but mortality rates were consistent across Europe, meaning that someone diagnosed with melanoma has a much higher chance of death in Eastern and Southern Europe than Northern and Western. In many of the countries where the odds are worst, public health programmes are non-existent or have only been recently introduced.

From the University of Leeds, Prof. Julia Newton Bishop shared the work of the GenoMEL consortium and their future programme. The consortium, funded under the Framework Programme Six, has studied large numbers of melanoma patients, looking for genes which predispose people to develop melanoma and have identified a number of ‘susceptibility’ genes. The studies rely on the use of biological tissue samples from large patient populations (in the two studies discussed, 1,500 and 3,000 patients were tested). Studying ‘melanoma families’ (families with three or more cases of melanoma) has helped identify hereditary melanoma genes, which opens the door for genetic counselling for relatives with this gene.

Prof. Newton Bishop emphasised that genetics offers the only route to learn more about how the patient’s immune system interacts with the tumour in a real-life setting rather than a group of cells in a laboratory. She urged the inclusion of biological samples in clinical trials, to help identify markers for patients who respond to particular treatments. This would not only lead to more personalised treatments and help to avoid useless toxicity, but would open new avenues for therapy development, and could lead to the development and authorisation of drugs which are very effective in a small number of cases, which is currently not the case.

The conference was interactive, with participants dividing up into multi-disciplinary groups to discuss specific aspects of melanoma policy. Those discussing patient care identified two key areas for progress. The first was the importance, and current lack, of reliable and up-to-date information about what treatments and trials are currently existing, with a centralised website identified as one possible means to address this. The second was the barriers to and inequalities in access to treatment, and the implementation of the Cross-Border Healthcare Directive will be key in this.

Those addressing detection and prevention agreed that there were many, many things which could be done in this area to reduce melanoma mortality. They focused on two steps which could be taken urgently: designing awareness campaigns targeted to reach at-risk groups; and revising existing European directives which are relevant. These would include the directive governing sun bed use; the directive defining sun cream as a luxury good and taxable as such; and the directive on the hazards of optical radiation in the workplace, which currently excludes sunlight.

Discussions on research and innovation concluded with three steps to make resources more accessible for researchers and to speed up drug development. The first proposal was to make it compulsory for all clinical trials to invite participants to submit biological samples. These samples would be accessible to all other researchers by application to an independent committee. The second proposal was to increase the funds allocated to an open call for applications in FP7/8, to facilitate long-term funding for essential projects which may not match the often political priorities of the EU’s funding allocation. The group also called for a centralisation of approval for clinical trials, which would cut the delay in obtaining authorisation for multi-centre trials by obviating the need to obtain authorisation in multiple countries with different systems.

Finally, the group considering access to trials and treatment welcomed the cross-border healthcare directive as improving access to new active treatments, while lamenting that the timeframes of clinical trials were such that some patients have no access to trials and thus to active treatment. The regulatory framework was called on to live up to patients’ expectation of having access to active treatments more readily. Secondly, they called for legislation to recognise the differences between academic studies and industry-sponsored trials, as they have different possibilities and goals. Requiring the same from both creates hurdles and inhibits research. They concluded by emphasising that, when assessing risk, we must first and foremost consider the risk to the patient of doing nothing. ECPC Board member and melanoma survivor Tom van der Wal spoke about the need for effective action to be taken to improve clinical trials in Europe.

MEP Marisa Matias spoke about the importance of prioritising cancer patients among all the other bureaucratic and political demands on MEPs and policy-makers. Detailing some of the documents produced by the European Parliament on issues already discussed, including cross-border healthcare and pharmacovigilance, she said that the problem was not lack of engagement by the Parliament, but the disjunction between what MEPs want to do and what power they have to put that into action. Some efforts in this have overlapped, with some policy areas over-governed and others left without a legal basis. For all these reasons, parliamentarians welcome initiatives such as M-ICAB. By joining forces, stakeholders can identify opportunities for collaborative action and support. She invited delegates to contribute to the green paper on research and innovation strategy as she is the rapporteur for the European Parliament. She concluded by reminding everyone present that, “we owe a lot to patients, and they should be the key orientation of our intervention.”

The delegates then divided into groups again, this time divided by disciplines. Patients and advocates spoke of the need for more information about available treatment and support to be disseminated. Catherine Poole, from Melanoma International Foundation in the USA, said that “an educated patient becomes very empowered – they live longer and happier.” Patients concluded that the only way to effect change was to speak up, and to assert themselves not only as patients but also as European taxpayers with a right to access the European Parliament.

The pharmaceutical industry agreed that there was a willingness among different companies to collaborate with one another and with other stakeholders, but that frameworks often limit it. They called for neutral ground, like ECPC M-ICAB, to come together and address these issues. They also highlighted that the problems, from their perspective, begin after regulation, with differences in Health Technology Assessments and a lack of EU support for patient access to drugs immediately after authorisation. They called on patient advocates to tell them how they can help.

Researchers summarised their views with two concrete proposals. The first was for half of future FP7 funding to be allocated through open calls, balancing specific needs for under-researched health issues with support for sustained best science. The second was to make biological sample collection integral to future clinical trials, allowing the identification of biomarkers in the future.

The final in-put came from drug regulators the European Medicines Agency. They expressed their frustration with receiving unfocused applications for drug approval, with no clear indication as to exactly who will benefit. With nine out of ten oncology drugs failing at phase III of the clinical trial process, regulators call on researchers to invest more time into each drug before taking it to clinical trials. Secondly, they agree that tissue collection is crucial. Companies tell us that they cannot collect samples because patients are reluctant to give them, while patient advocates show that there is willingness among the patient community to do whatever they can to improve treatments for themselves and for the next patient.

The event was concluded by Marisa Matias MEP, who urged everyone present to speak out in the European Parliament and have an input in consultations through ECPC FACE Champions, saying “This is your house, come in and speak with us through ECPC.”

Download the press release in PDF