Spain prevents automatic substitution of
biological medicines, providing clarity for pharmacists and patients
Brussels, 12 October 2007 EuropaBio - the EU association for
bioindustries - welcomes the new Spanish Ministry of Health and Consumer
Affairs Ministerial Order (MO) that prevents one biological medicine
being automatically substituted for another. The Order demonstrates the
Spanish authorities' recognition that biological medicines are complex
and cannot be automatically substituted for administration to patients.
The regulatory piece, outlined in Order SCO/2874/2007 and passed on 28
September, 2007, specifically excludes certain medicines, due to their
particular therapeutic or pharmacological characteristics, from
substitution by pharmacists, without express permission from the
prescribing physician. The fundamental goal is to protect patients, as
stated by the Order. This MO is an update of the former MO, 28 May 1986,
based on the acknowledgement of recent scientific and medical evidence
for a certain group of medicines. It is the first time that the MO
includes biological medicines.
"We applaud the new Spanish regulation that protects patient safety. It
is important that the biotechnology industry has an appropriate
regulatory framework in place, which provides clear guidance to
pharmacists and patients alike", commented Mr. Andrea Rappagliosi, Chair
of the Healthcare Council, EuropaBio.
The Spanish Order follows a similar law on medicinal products, including
biosimilars taken by France earlier this year approved by the French
Parliament. The law stipulates that biotechnology-based reference
products and biosimilars are not identical and therefore such reference
product cannot be substituted at the pharmacy level by a biosimilar
product automatically.
"Spain and France are providing leadership on this issue by pursuing
patient-centred policies. We hope other countries will also provide such
clear guidance", Mr Rappagliosi concluded.
The decision by Spain follows guidance in the recent EMEA Q&A on
biosimilars that states, 'since biosimilars and biological reference
medicines are similar but not identical, the decision to treat a patient
with a reference or a biosimilar medicine should be taken following the
opinion of a qualified healthcare professional '.
For further information, contact:
EuropaBio's Healthcare Council Director,
Michael Leader, Direct Tel: +32 2 739 1183
Email: m.leader@europabio.org
EuropaBio's Communications Director,
Adeline Farrelly Direct Tel: +32 2 739 1174 Mob: +32 475 93 17 24
Email: a.farrelly@europabio.org
About EuropaBio
EuropaBio, the sole and unique European Association for
Bioindustries, has 85 direct members operating Worldwide, 12 associate
members and 5 bioregions as well as 25 national biotechnology
associations representing some 1800 small and medium sized enterprises
involved in research and development, testing, manufacturing and
distribution of biotechnology products.
http://www.europabio.org
