Spain Prevents Automatic Substitution Of Biological Medicines, Providing Clarity For Pharmacists And Patients

Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Pharma Industry / Biotech Industry;  Pharmacy / Pharmacist
Article Date: 13 Oct 2007 - 9:00 PDT

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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 '.

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

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