Case studies: Italy, Spain, Romania
Before the workshop split into smaller break-out groups to look at specific aspects of developing the EUPATI presence at the national level, it heard three case studies: from Italy, Spain and Romania. Each dealt with a different kind of experience. Italy and Spain are both core countries of the EUPATI project and both have established National Networks.
But although EUPATI has had to limit the scope of its funded operations – the money simply isn’t there for complete European coverage at this stage – this has not stopped other countries from seeking to set up their own Teams and Platforms. Romania is one such country.
Italy – central and local
The case studies began with Italy. Silvio Berioli from the European Forum for Good Clinical Practice, Italy, dived straight into the difficulties. One complication in Italy is the sheer number of patient organisations – somewhere between nine and ten thousand, with some local, others regional or national, large variations in experience, and with many organisations for the same disease or condition.
Among the hurdles listed by Berioli were variations in management expertise, the difficulty in finding human and financial resources, and the fact that each patient organisation can be jealous within its own network. “We have to be willing to share. Not just to talk about it, but really,” he said.
As if all that were not enough, Italy has no established, standard way in which patient organisations work with pharma companies. Sometimes, as well, patient organisations are led by ex-politicians or “prima donnas”, VIPs, each with their own agendas. And the media aren’t much help. “We have to explain to them that this is not ‘a problem’. It is ‘the problem’,” he said.
With all those problems, where do you start? “Our crucial approach was to have a central strategy and a local strategy,” said Berioli. Centrally, the aim was to invent the idea of the “mentor”, someone with recognised experience of Italy’s political and institutional environment. Locally, the first task was to find the right people for the National Networks.
Here Berioli was quite specific: they were looking for people at what he called the “intermediate level”, from organisations that were neither too big nor too small, but with plenty of experience – “people with friends everywhere”. Once they were found, the next job was to decide how to work together and divide up the tasks. Then they set out to identify institutional and academic partners to endorse the European Patients’ Academy.
Here they struck luck, becoming the first organisation in Italy to be endorsed by both AIFA (Italy’s medicines agency) and the Rome Chapter of ISPOR, the International Society for Pharmacoeconomics and Outcomes Research. These successes were followed up with the creation of a scientific board for the National Network, launched just 12 days before the Dublin workshop.
So far, the Network includes more than 200 patient organisations.
Spain – first find your stakeholders
The Spanish experience was presented by Daniel Gil from Spain’s industry association, Farmaindustria. Spain’s National Network, he explained, began in 2013 with the creation of a National Liaison Team with four partners: two patient organisations, Spain’s main university (Complutense University of Madrid) and, the country’s pharmaceutical industry association. The next key step was, like Italy’s, the appointment of someone to drive the work forward – Laura Kavanagh, the Network’s coordinator.
Then they approached Spain’s health ministry, including the person responsible for relations with patient organisations. As Gil put it, “They may be reticent to engage with EUPATI until they learn more about the role of industry and [its] influence on patients within the project.” (The experience here is not unique…Others, later in the workshop, talked about the problems persuading people that cooperation with industry is just that, cooperation, rather than domination by industry.)
After the National Platform was launched in December 2014, nine were elected to form the executive board at a meeting held with all the organisations interested in EUPATI. Six are from patient organisations, two from academia and one from industry.
The National Platform then set about enthusiastically spreading the word about EUPATI, with a series of events in Barcelona, Toledo and Madrid during the spring. Further events are planned for later in the year. Work is being developed around three themes: content (for the expert patient courses, toolbox and Internet library); education activities; and communication via mass media and social networks.
Stakeholder work has a high priority. The Network is working with many companies and hopes to involve other companies soon. It will now work with Spain’s medicines agency (AEMPS) to collaborate in informational and educational work – something that might be a more effective route to work with the government than via the health ministry. Communication with patients is assured through Spain’s two largest patient organisations.
High on the agenda for future work is Spanish participation in the patient expert course. Only one of the first tranche of 50 is from Spain, but there are now 20 Spanish candidates for the second course (fingers crossed!). Meanwhile, the Network is waiting for publication of the expert course material in English, to translate and use to mobilise further Spanish patient engagement. And (like many others at the workshop) the team is looking forward to working with the Research Toolbox.
Gil finished describing the “new landscape” being created in Spain that will allow patient advocates to take part in ethics committees, in the design of clinical trials, and in the writing of therapeutic recommendations. EUPATI’s existence and resources will be crucial in making such collaborations work, he said.
Romania – on the way
Romania may not be on EUPATI’s initial list of 12 countries, but with 22 million people (and 3 million Romanian-speakers in Moldova) it is the second most populous country in central and eastern Europe. And it is pressing ahead with plans to set up a National Network, as Rozalina Lapadatu from Romania’s Autoimmune Diseases Patient Association explained.
On paper, the country’s health law provides for a fair amount of patient engagement, but in practice it is “not well implemented”, said Lapadatu. Patients are represented in what she called “legal debates” about the health system, and on hospital ethics committees, but not in the Romanian Drug Agency’s ethical committees and not at meetings on health technology assessment.
Lapadatu described a situation that is not unusual in Europe, “We need stakeholders to listen to what we have to say, because physicians, academia and pharma are focused on their own goals, but forget that it should all be for our benefit as patients.”
Against this background, they are working to establish a National Network. The team consists of Romania’s three expert patient students (including Lapadatu), a key academic (the chair of internal medicine and rheumatology at Bucharest University), and two media partners. Contacts with industry have been encouraging, and the team is waiting for some internal approvals before they can announce the names of industry partners. Discussions have begun with the Ministry of Health and medicines agencies.
As in Spain, the team has been promoting patient education and its values to media audiences and at professional meetings. “We believe the first brick in our wall is education,” said Lapadatu. “We have to start there.” She hopes that EUPATI will give patient representatives the confidence to work with industry and government. On a visit to the Ministry of Health she recalled an official asking why she was there. “I said I was here as a patient. Now I can say I am here as a patient expert.”