Sustaining Generic Medicines Markets in Europe

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Sustaining generic medicines markets 264.2 Generic medicines policy4.2.1 PricingThe Netherlands enforced pricing regulation setting maximum prices of medicines in 1996.Companies that set prices above the maximum level are liable for criminal injunction. Themaximum price is based on the average price of both originator and generic medicines having thesame active substance, strength and dosage form in Belgium, France, Germany and the UnitedKingdom. In general, this led to a 15% fall in medicine prices (Danzon and Ketcham, 2003).However, the level of medicine prices still tended to be higher in the Netherlands as compared toother EU countries in the early 2000s (Koopmanschap and Rutten, 2003). Health insurancefunds, pharmacists, generic medicines companies, and the Government agreed to reduce pricesof generic medicines by 40% (including claw-back) on average in 2004. Medicine prices were atthe average level of EU prices in 2005.4.2.2 Reference pricingIn 1991, a RPS by therapeutic class was introduced. Irrespective of patent status, medicines witha comparable therapeutic effect were grouped if they had the same mechanism of action, asimilar route of administration for treating the same indication in the same age group and acomparable clinical effect. For each active substance in a homogeneous group, the average priceper defined daily dose of all originator and generic medicines with that active substance iscalculated. The RP is then set as the median of the distribution across all active substances in thegroup.The 1996 pricing regulation introduced maximum prices for many medicines below the level ofRPs (Danzon and Ketcham, 2003). In 1999, RP levels were recalculated taking into accountactual prices.4.2.3 Incentives for physiciansSince 1995, the Dutch Government has stimulated physicians to prescribe by INN. This has beensupported by the introduction of an electronic prescription system, although this system is not yetwidely used.The Netherlands has a tradition of developing and implementing prescribing guidelines andtreatment protocols that promote the efficient use of medicines. Local pharmaco-therapeuticdiscussions take place periodically between GPs and community pharmacists to evaluate
Sustaining generic medicines markets 27medicine prescribing and dispensing, and formularies have been developed to rationaliseprescribing practices. Information campaigns have urged physicians to use generic names ratherthan brand names. There are no sanctions for physicians who do not respond to these incentives.A recent initiative by one health insurance fund is the introduction of a financial stimulus for thedoctor if (s)he uses generic medicines more frequently. This initiative has been legally challengedby the originator medicine industry.4.2.4 Incentives for pharmacistsGeneric substitution by pharmacists is allowed if physicians and patients agree with it. Physicianscan indicate on the prescription form that generic substitution is not permitted for medicalreasons. When the physician prescribes a branded originator medicine that is out of patent andgeneric substitution is allowed, the pharmacist can dispense any generic medicine withoutreference to the physician. If the prescription is issued by INN, the pharmacist may dispense anyoriginator or generic medicine. Health insurance funds have also agreed a target rate of genericsubstitution with pharmacists.Pharmacists receive a fixed dispensing fee per prescription. This implies that the delivery of ageneric or originator medicine is neutral from a financial perspective. As a consequence, it is inthe interests of pharmacists to dispense the medicine with the highest profit margin. Two policymeasures were introduced in the early 1990s that have a financial impact on pharmacistdispensing practices. First, if the pharmacist issues a medicine that is priced below the level ofthe RP, the pharmacist can retain one third of the price difference between the price of themedicine and the RP. Second, pharmacists can keep any discounts awarded by pharmaceuticalcompanies since 1991. Pharmacists are thus able to retain 100% of discounts offered bywholesalers, but only 33% of the difference between the medicine price and the RP. This led tocompetition between companies through discounts to pharmacists rather than lower medicineprices. In fact, prices of several generic medicines were raised to the level of the RP (Brouwerand Rutten, 2002). Therefore, since 1998, a claw-back system imposed a mandatory reduction inpharmacists’ reimbursement of 6.82% of medicine acquisition costs. This claw-back mechanismdoes not intend to fully recover discounts as discounts are seen by the Government as aninstrument to remunerate pharmacists, obviating the need to increase the fixed dispensing fee.
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Generic medicines create major savi
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Sustaining Generic Medicines Markets in Europe

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