Table 2.
Some EU countries which have taken specific measures to limit or prohibit substitution of innovators with biosimilars, in others current law prohibits automatic substitution of innovators with generics
| Country, Regulation (Year regulation came into force) | Specific to biologics? | |
|---|---|---|
| No automatic substitution allowed | ||
| France 2006 | In 2006 French Law (LOI no 2006-3062, article 11) prohibited automatic substitution of biosimilar products (75). | Yes |
| Germany 2008 | The automatic substitution of biologics is not permitted in Germany. In January 2008, German Social Law (Rahmenvertrag 20080117, § 129) indicated that pharmacists are obliged to prescribe a generic product when available, and that physicians must actively prohibit automatic substitution when prescribing, however, this does not apply to biologics (76) | No |
| Greece 1976 & 1993 | Greek Law (ND 96/1973 – Article 13, section 3) states that pharmacists are obliged to provide the exact pharmaceutical products mentioned in a medical prescription and are absolutely prohibited from substituting them with other pharmaceutical products (77). | No |
| This is reinforced by the Greek Code of Ethics for Pharmacists (PD 340/1993 - Article 23), which states that pharmacists are not at liberty to substitute the pharmaceutical products stated in a prescription with any other product (78). | ||
| Italy 2007 | Based on a note from the Ministry of Health, the Italian Council of State issued opinion (n.3992.07) stating that biosimilars cannot be substituted (79). | Yes |
| Slovenia 2008 | Slovenian Medical Society guidelines prohibit the substitution of biologics, any medicinal product should be approved for substitution by the Slovenian Medical Society (80). | Yes |
| Spain 2007 | In 2007, the Spanish Health Agency (Ministerio De Sanidad Y Consumo) stated that biologics as not substitutable - ORDEN SCO/2874/2007 (81). | Yes |
| Sweden 2007 | In 2007, the Swedish Medicines Agency (MPA) issued a statement saying that biologics are not interchangeable and are not recommended for substitution (82). | Yes |
| UK 2010 (ongoing) | At present there is no automatic substitution of biologics in the United Kingdom, if the physician prescribes by brand, this is what must be given. There is ongoing consultation about the introduction of automatic substitution. The Department of Health (DoH) and the Association of the British Pharmaceutical Industry (ABPI) have proposed to Medicines and Healthcare products Regulatory Agency (MHRA) that biologics/biosimilars should be exempt from automatic substitution and that biologics should only be substituted with prescribing physician's knowledge and prior consent. The MHRA has stated that it is best practice to prescribe by brand name to ensure traceability (83). | Yes |
| Automatic substitution must be actively prohibited by the physician | ||
| Czech Republic 2008 | In January 2008, Czech Drug Law (No 378/2007, § 83, article 2) was updated to state that automatic substitution of any originator product with a generic must be actively prohibited by the physician (84). | No |
| Official list stating which products cannot be substituted | ||
| Denmark 2010 | Biosimilars can be substituted for each other, but not for reference products in the substitution lists issued by the Danish Medicines Agency (DKMA; (85)). | Yes |
| Finland 2009 | The Finnish Regulatory Agency (FINMEA) states that products given parenterally are not substitutable (86). | No |
| Hungary 2009 | Biosimilar products are absent from the positive substitution lists issued by the Hungarian National Institute of Pharmacy, thereby preventing their automatic substitution (87). | Yes |
| Norway 2010 | In Norway, all pharmaceuticals that are regarded as generics or therapeutically equivalent should be put on an automatic substitution list. Although filgrastim was initially considered for substitution, in July 2010 the Norwegian Medicines Agency (NOMA) announced that until further notice filgrastim will be taken off the substitution list (88). Biosimilars are absent from the October 2010 substitution lists (89). | Yes |
| Slovakia 2008 | Biosimilar products are absent from positive substitution lists published by The Slovakian Ministry of Health (90). | |
| Physicians obliged to prescribe by brand name | ||
| Austria 2005 | Austrian Medicines Law (AMG § 10 section 8) recognises that biosimilars are not generics. Physicians are obliged to prescribe by brand name and to look for the cheapest but best medicines for their patients therefore there is no obligation to substitute biologics and this responsibility lies with the physician (ökonomische Verschreibung, RÖF 2005; (91)). | No |