MR Code of Conduct alerts
EphMRA proactively looking to influence critical new
legislation
In July 2012, new pharmacovigilance legislation will come into
effect that includes adverse event reporting (AER). Right now, the
European Medicines Agency (EMA) is defining the ‘legislative
implementing rules’ – which will impact AER from a market research
perspective. EphMRA has been invited to join the consultation
process. This is a highly significant piece of legislation and a
critical opportunity for EphMRA to make our voice heard.
About the legislation
The new pharmacovigilance legislation (Regulation (EU) No
1235/2010 and Directive 2010/84/EU) was adopted by the European
Parliament and European Council in December 2010, and is effective
from July 2012. According to the EMA: "The legislation is the
biggest change to the regulation of human medicines in the European
Union (EU) since 1995. It has significant implications for
applicants and holders of European Union marketing authorisations."
You can
find full details here.
The Consultation Process
To define its set of 'legislative implementing rules', the EMA
has begun a dialogue with stakeholders through its website, formal
public consultations and stakeholder workshops. Based on this
process, the rules detailing how the legislation is to be
implemented will be drafted, and AER requirements from MR in the EU
will be revised.
Having contacted the EMA, EphMRA has now been invited to raise
questions and any issues of concern. This is a rare and important
opportunity to make our voice heard. The consultation period ends
on 7 November 2011 so time is of the essence. EphMRA has convened a
small team of senior and experienced pharma market researchers
headed by Bob Douglas (EphMRA’s Ethics Group Lead) and this group
will be involved in the consultation process, framing and
communicating EphMRA’s issues.
Our goal is to represent the voice of international healthcare
market research in Europe – promoting understanding of AER
implications for MR, and trying to ensure that the demands placed
on our industry are reasonable. This Team is currently looking at
the EphMRA position on AER in the light of the new upcoming
legislation and will be developing the Association’s position in
relation to a submission to the EMA. This is in its very early
stages and so when we have an update we will be back in touch. In
the meantime feel free to make any suggestions and email generalsecretary@ephmra.org