Belgium does not have a coherent generic medicines policy and there is no generic medicines competition within the existing regulatory frameworks [1].
Although in Belgium the same pricing scheme is applied to both in-patent and off-patent medicines, generics have to be priced lower than the reference price if generics wish to receive reimbursement [2, 3].
A reference pricing system (RPS) has been in place since June 2001 [2,4] which imposes a fixed price difference between generics and the originator [5]. This currently stands at 70% of the originator price [6].
A regulatory framework governing international non-proprietary name (INN) prescribing was introduced in 2005. However it is not compulsory for physicians to prescribe by INN, and in 2008, only 3% of prescriptions in Belgium were written by INN [7].
Patient co-payments in Belgium are high compared to other European countries and Belgian policy attempts to foster demand for generic medicines by increasing patient co-payment for specific medicine classes and for off-patent branded medicines [2].
Pricing
The Transparency Directive 89/105/EEC specifies a 90-day limit for adopting a decision on price and a 90-day limit for reimbursement. However the time delay for price approval in January 2005 equalled 90 days in Belgium, delaying the introduction of generics onto the Belgian market.
The pricing procedure for generics is the same as that for branded medicines [2].
Generic medicines need to be priced at or below the level of the reference price (RP) in order to qualify for reimbursement.
In 2006, a policy measure was introduced to reduce the turnover of pharmaceutical companies by 2%. This reduction can be accomplished by a 2% price decrease of medicines. Alternatively, companies can choose to reduce the price of specific medicines by a minimum of 4% in order to achieve a total fall in turnover of 2% [3].
Reference pricing
A reference pricing system (RPS) termed the Reference Reimbursement System in Belgium by active substance was implemented in June 2001 for medicines with generic equivalents [2, 4]. The RPS in Belgium works by imposing a fixed minimum price difference between generic and originator medicines [5].
Over time, the Belgian government has progressively reduced the RP from 84% (until July 2002), 80% (until January 2003) to 74% of the price of the originator medicine (until July 2005). The current level stands at 70% of the price of the originator medicine [6].
After its introduction in 2001, the RPS was associated with an increased market share of generic medicines [5]. The RPS was enlarged in 2005 to include all pharmaceutical forms and dosages of the same active substance.
Additionally, the law offers the possibility to set a RP for a class of medicines with a similar therapeutic indication. If prices of originator medicines fall under the 2006 pricing policy, the corresponding RPs decrease as well.
Incentives for physicians
Prescribing guidelines exist that provide comparative information about, amongst other things, costs of medicines in a number of therapeutic classes.
There are no incentives for physicians to prescribe the most efficient medicine and physicians do not have to adhere to these guidelines.
In 2005, a regulatory framework governing international non-proprietary name (INN) prescribing was introduced. This makes it possible, but not compulsory, for physicians to prescribe by INN. In 2008, only 3% of prescriptions in Belgium were written by INN [7].
In 2006, quotas for prescribing low-cost medicines—generic medicines or originator medicines that have reduced their price—were assigned to physicians [2]. The volume quotas, expressed in defined daily doses (DDD), affect reimbursable outpatient medicines dispensed by retail pharmacies, but not pharmacists’ magistral preparations. For the physicians, the minimum prescribing rate for lower priced medicines is 27% of all prescriptions expressed in DDD.
Pharmanet (an information system created in 1996) data are used to check whether physicians comply with quotas. If physicians prescribe expensive medicines inappropriately, they are monitored by the Ministry of Health for at least six months and receive information and training in low-cost prescribing.
Incentives for pharmacists
A law permitting generic substitution by pharmacists conditional on getting approval from the prescribing physician and patient was passed in 1993. However, as the royal decree necessary to put this legislation into practice has not been passed to date, generic substitution by pharmacists is not allowed.
If the physician prescribes by INN, the pharmacist can dispense an originator medicine or any generic medicine priced at or below the level of the RP in consultation with the patient. If this option does not exist, the pharmacist can dispense an originator medicine priced above the level of the RP. Failing this second option, the pharmacist can deliver an originator medicine not included in the RPS. The choice of medicine by the pharmacist is inspired in the first instance by the therapeutic interests and continuity of care of the patient; and in the second instance, by the price of the medicine.
Since April 2010, pharmacist margins in Belgium are made up of two components: a fixed lump sum and an economic margin set as a percentage of the price of the medicine (4%). This system aims to make the delivery of generic medicines neutral to pharmacists from a financial perspective. Even though discounts to pharmacists and other commercial practices do not violate pharmaceutical legislation, questions remain over the legality of discounting in Belgium.
Incentives for patients
Patient co-payments in Belgium are high compared to other European countries [2], and range from 0% to 80% of the medicine price depending on the type of patient and medicine. Belgian policy attempts to foster demand for generic medicines by increasing patient co-payment for specific medicine classes and for branded medicines that are off-patent [2].
Maximum patient co-payment on a range of non-life-saving generic medicines increased at the end of 2005.
In 2004, the Government launched an information campaign to increase patient awareness of generic medicines. However, the campaign was short-lived and had limited exposure, therefore its impact is likely to have been limited.
Articles titled 'How successful is the reference pricing system in Belgium' and 'The reference pricing system: a socio-economic analysis of the use of low cost medicines in Belgium' giving further insight in the reference pricing system in Belgium have been published in GaBI Online.
Policy analysis
Key factors aiding the development of the generic medicines market
- Generics use has been stimulated by the introduction of a reference pricing system (RPS).
- Patient co-payments are lower for generics.
Key factors hindering the development of the generic medicines market
- Successive reductions of the RP and the guarantee of absolute pharmacist margins threaten the economic viability of the generics market.
- Medical students are not taught to prescribe by INN.
- Physicians have few incentives to prescribe generics.
- There are no incentives for pharmacists to dispense generics.
References
1. Bongers F, Carradinha H. European Generic Medicines Association (EGA) Health Economics Committee. How to Increase Patient Access to Generic Medicines in European Healthcare Systems. June 2009.
2. Österreichisches Bundesinstitut für Gesundheitswesen (ÖBIG). Surveying, Assessing and Analysing the Pharmaceutical Sector in the 25 EU Member States. July 2006.
3. Simoens S, De Coster S. Sustaining Generic Medicines Markets in Europe. April 2006. [monograph on the Internet]. Brussels, Belgium, European Generic Medicines Association (EGA) [cited 2011 May 13]. Available from: www.egagenerics.com/doc/simeons-report_2006-04.pdf
4. Federaal Kenniscentrum voor de Gezondheidszorg (Belgian Healthcare Knowledge Centre [KCE]). The reference price system and socioeconomic differences in the use of low cost drugs. KCE reports 126C. 2010.
5. Simoens S. Generic medicine pricing in Europe: current issues and future perspective. J Med Econ. 2008;11(1):171-5.
6. Simoens S, De Bruyn K, Bogaert M, Laekeman G. Pharmaceutical policy regarding generic drugs in Belgium. Pharmacoeconomics. 2005;23(8):755-766.
7. INAMI/RIZIV. Info Spot. Het voorschrijven op stofnaam. In; 2008 [monograph on the Internet]. Brussels, Belgium, Rijksinstituut voor ziekte en invaliditeitsverzekering (RIZIV) / l'institut national d'assurance maladie invalidité (INAMI) [cited 2011 May 13]. Available from: www.riziv.fgov.be/drug/nl/statistics-scientific-information/pharmanet/info-spot/2008-03-27/pdf/infospot20080327.pdf
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