{"id":36615,"date":"2016-05-05T16:20:39","date_gmt":"2016-05-05T15:20:39","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=36615"},"modified":"2016-05-05T16:21:11","modified_gmt":"2016-05-05T15:21:11","slug":"matthias-wienold-drug-regulation-a-patients-view","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2016\/05\/05\/matthias-wienold-drug-regulation-a-patients-view\/","title":{"rendered":"Matthias Wienold: Drug regulation\u2014a patient’s view"},"content":{"rendered":"

\"Matthias_Wienold\"The European Medicines Agency (EMA) guards access of new drugs to the health markets of the EU member states. It was founded over 20 years ago to combine the best of knowledge from all national agencies and to respond to the need to speed up the evaluatory process, which in some countries could take more than three years.<\/p>\n

The EMA also listens to the patient’s voice, which I heard about in more detail at the recent 7th Global Patients Congress<\/a>, where Nathalie Bere from the EMA talked about how the agency makes use of patients as a resource<\/a> and how they recommend including patients from the very first steps of regulatory approval.<\/p>\n

I learned that in 2015 more than 500 patient representatives gave their input, on behalf of organisations and as individual experts. And I noted that 46% of their comments had been so well received that they became adopted as changes. These comments related to public information, package leaflets, and safety communications, and they were added during the full cycle of regulation from pre-submission to post-authorisation. That\u2019s a fair share to my mind.<\/p>\n

The EMA has over time contributed a lot\u00a0to how drug regulation in Europe is communicated to patients. Even from the perspective of patients\u2014who can be critical of how drug regulation works and its \u201civory tower\u201d perspective\u2014that is to be applauded. The growth of information on clinical research and drug regulation that is targeted to patients has also been supported by patient organisations, funding from the European Commission, industry-driven initiatives, and national governments.<\/p>\n

Today you can look for guidance online, and there are many online resources with information, testimonials, training materials, and the like in several languages and for specific diseases and audiences. The European Academy Patients\u2019 Academy<\/a> is a recent example of this emergence of new information.<\/p>\n

This focus on patients at the EMA has come about since 1996 as a result of the organised activities of patients and advocates. In our first meeting with the EMA as patients representing the European AIDS Treatment Group (which has retained that name), the EMA\u2019s representative asked us what we wanted to achieve. Our answer was simple: \u201cWe want to be involved in every decision you take.\u201d And in addition to this plain request, we had a more detailed agenda.<\/p>\n

Our strong points were simple, but even today they hold true. (1) Nobody knows more about the needs of patients than the patients themselves. (2) The qualitative reporting from organised patients is often ahead of formal reports. (3) There is no use in approval if patients won\u2019t take the drug. (4) All structured information about experimental use and safety of compounds needs to be taken into account. (5) \u201cThis is not the last time you meet with patients.\u201d<\/p>\n

When we came to the EMA in 1996 representing the European AIDS Treatment Group\u2014the first patient organisation to be thus acknowledged\u2014the three of us were well dressed and we spoke English, French, and German. We could talk about our lives in clear terms and we could base our arguments on hard evidence. We were acting on a common agenda. We followed up on the meetings. Today we\u00a0are<\/a> men who have sex with men (MSM), women, drug users, haemophiliacs, mothers and fathers, lovers and friends.<\/p>\n

Are we in patient paradise now? No, and there is difficult work ahead. Concerns around transparency of data and processes, and the need to account for new methods of input (by emails and personal reports), are ongoing and need to be resolved. There is also a debate brewing about whether it is wise of the EMA to exclude \u201cexpert patients\u201d (who sign confidentiality agreements) from communicating openly with peers from their own organisation.<\/p>\n

Patient organisations have some way to go\u00a0in expanding their role at the EMA, and in drug regulation more globally, before nothing remains to be changed. The idea of patients in drug regulation isn\u2019t that easy to swallow for some, but it has proven to provide\u00a0a valuable link to patients\u2019 realities and understandings, over and over again.<\/p>\n

Matthias Wienold<\/strong>\u00a0represents the European AIDS Treatment Group (EATG) at the International Alliance of Patients’ Organizations (IAPO). He is an elected governing board member of IAPO.<\/em><\/p>\n

Competing interests:<\/strong> I have read and understood BMJ policy on declaration of interests and declare the\u00a0following interests: I am a member of the European AIDS Treatment Group.<\/p>\n","protected":false},"excerpt":{"rendered":"

The European Medicines Agency (EMA) guards access of new drugs to the health markets of the EU member states. It was founded over 20 years ago to combine the best […]<\/p>\n

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