In a news release issued by the European Organisation for Rare Diseases (EURORDIS) this week, the society commended the European Medicines Agency (EMEA) in its efforts to make the information that it has available on medicines more patient-friendly.

The society was referring specifically to a report issued earlier this year by EMEA, which highlighted some of the failings of the agency and other regulatory authorities to provide clear information on the risks and benefits of medications in a language that is clear and understandable to patients. The report was based on the results of a survey of regulators, healthcare providers, patients and consumers across Europe.

EURORDIS has shown a particular interest in this survey because of the increasing involvement of patients and consumers in treatment decision-making. According to the society, this is especially true for rare disease patients who are often very involved in the management of their disease.

In its report, EMEA highlighted the importance of simplified information provision on the benefits and risks of medicines. According to the EURORDIS release, this “is particularly critical to orphan drugs which are often developed under exceptional circumstances and for which there is less long-term information about safety than for regular drugs.”

As the number of patients going it alone and seeking information on their disease and treatment options continues to escalate, the importance of reliable and good quality information becomes even more critical. The fact that the public has free access to an inordinate amount of information, which is largely unregulated, via the Internet, is naturally a concern to regulators, healthcare professionals and drug manufacturers so the EMEA’s efforts to address this problem are indeed commendable.

According to the agency’s report, regulators need to take more responsibility for the dissemination of reliable information on medicines to healthcare professionals and patients. This information should clearly present the benefits and risks of a therapeutic in lay language, and should identify patient subgroups for whom risks or benefits may differ. It is recommended that warnings and clinical trial information should also be presented in understandable terms.

EMEA, along with its patient, consumer, and healthcare professional working groups, have now outlined an action plan, which aims primarily to optimize the provision of regulatory information that fulfils patients’ and healthcare professionals’ expectations in a number of ways and through different tools and channels. While this is indeed an admirable undertaking, one might ask how feasible it will be to create, in essence, a one-stop information shop for patients and healthcare professionals that is not only comprehensive, but is also sufficiently publicized so that the public are aware of its existence and opt to visit this trusted information source over and above any other.

Naturally, it will be mission impossible to prevent patients from basing decisions on potentially inaccurate and/or unregulated information, but the idea of a harmonized public access information source, issued by regulators, is very exciting. According to the report, ideally “a central web portal provided by EMEA and national competent authorities” could be used to disseminate trusted information on medicinal products.

Suggestions relating to the expansion of the existing Eudrapharm database of information on all medicinal products authorized in the EU were made within the report. Although the idea of this database, which is available in most European languages, is an interesting one, the information that it currently stores on approved medications is severely limited and is of no real use to patients as it stands. As such, if it were to be considered a valuable resource for healthcare professionals and patients, it will require a significant investment of time and money.

According to Francois Houyez, Health Policy Officer at EURORDIS and patient representative at the Patients’ and Consumers’ Working Party (PCWP) of the EMEA in this week’s EURORDIS release, “This is the first time that patients, doctors and regulators are thinking together to define the benefit-risk ratio of drugs and how best to communicate it. Patients who take orphan drugs have been asking for more balanced information, not only information about the risks they are exposed to, but equally important the benefit they can expect.” He concluded, “This project and the recommendations coming out of it are a real step forward in this direction.”

I couldn’t agree more!