Medicines are developed to benefit patients, yet historically,
their views have been overshadowed by the views of healthcare professionals. Regulators
have tended to follow this pattern too, but are now committed to fully
involving patients in decision making wherever possible. The move of patients
from being a passive voice in healthcare to an active
one has helped bring about this change. Patients have not only become
better informed, but also increasingly
vocal in what they desire in terms of healthcare. A number of patient
groups have formed worldwide
alliances to represent their views.
Patients have been involved in the development of new regulations
around the world, but not in a consistent manner. The AIDS
crisis led to considerable patient pressure being placed on regulators in
the US to ensure that new medicines were developed. Similarly, the legislation
concerning orphan
medicinal products for rare diseases has been greatly influenced by the
work of patient groups in the EU, US and other regions.
Historically, the
US has been seen as further ahead in recognising the views of patients in
medicines regulation. The FDA has a section called the Patient Network, whose role is to
ensure that the perspectives of patients, family members, caregivers, and
patient advocates are not overlooked during the review process. The FDA also
put in place a Patient-Focused
Drug Development (PFDD) program to systematically
involve patients and this features regular
meetings for different disease areas.
The European
Medicines Agency (EMA) has interacted with European patients since it was
founded in 1995, but is seeking to formalise
this type of engagement. The Agency works via a network of over 30 European
patients’ and consumers’ organisations that must fulfil certain eligibility
criteria. There is a framework
to direct how interactions between regulators and these groups take place. Currently,
patients can be asked to become involved in a variety
of activities, ranging from taking part in scientific
advisory groups to being involved in the preparation of guidelines. The EMA
Human
Scientific Committees’ Working Party with Patients’ and Consumers’
Organisations (PCWP) was established to provide recommendations on all
matters of direct or indirect interest to patients.
In September
2013, the EMA held a workshop in London that brought together representatives
of patients, consumers, healthcare professionals and the pharmaceutical
industry with members of the EMA’s
scientific committees and staff. The aim was to get a better understanding
of how patients could become further involved in the assessment process for
medicines, particularly when it came to benefit
and risk evaluation. The EMA appears committed to further involving
patients in its activities and will be using the outcomes of the workshop
to make further improvements to its processes. Presently,
it produces an annual report on its involvement with patients that includes a
satisfaction questionnaire.
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