European Medicines Agency widens access to its documentsBMJ 2010; 341 doi: https://doi.org/10.1136/bmj.c7039 (Published 07 December 2010) Cite this as: BMJ 2010;341:c7039
All rapid responses
The European Union (EU) is known for having a persistent serious concern
for health of its population as well as health care standards. People have
a wide range of curiosities and queries when they have to take a drug or
medicine in the twenty first century. Because of the stringent standards,
European Pharmacopoeia, British Pharmacopoeia and British Herbal
Pharmacopoeia are followed in a number of countries. Many of the
developing countries rely on their European counterparts for primary
research evidence for existing and new drugs.
THe European Medicines Agency (EMA) is a London-based decentralized agency of
the EU entrusted with the responsibility of the scientific evaluation of
medicines used or intended for use by EU populations .
It is appreciable to read that EMA has made many of its documents on the
regulatory filings accessible for the general public as well as health
care professionals . Being stakeholders in health and health care
sector, they have a right to enquire about drugs. One may fail to comprehend why EU failed to provide information without
the interference by the ombudsman,
Nikiforos Diamandouros . No?l Walthion, the Patient Health Protection
Head at EMA is correct in his assertion that the openness and transparency
 are fundamental policies in drug regulatory affairs at EMA.
Providing no access or delayed information on scientific evaluation of
therapeutic and toxicological effects of drugs or medicines can cast
aspersions on the integrity of the process as well as that of the
organization / its staffers. It is the responsibility of EMA to ensure
that no one has an opportunity to raise doubts on the EMA working in
general and health policies of the EU in particular.
It is indeed a welcome step that public now has access to some of the EMA
documents. This initiative needs to be followed by drug regulatory
agencies in all nations across the globe.
1. EMA website: http://www.ema.europa.eu/ accessed on Jan 24, 2011.
2. Watson R. European Medicines Agency widens access to its documents. BMJ
3. Watson R. EU ombudsman criticises drug agency over access to documents.
BMJ 2010; 340:c3474.
Competing interests: Pharmacy Teaching at UG and PG level.