Generics policies in Europe have room for improvement

Genéricos/Investigación | Posted 15/02/2013 post-comment0 Post your comment

In Europe, generics policies have not yet been implemented to their full extent, according to authors Vogler and Zimmerman, reporting on the 2011 Pharmaceutical Pricing and Reimbursement Information (PPRI) Conference [1, 2].

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The basics for implementing a generics policy have been outlined for more than a decade in World Health Organization’s (WHO) guideline ‘How to develop and implement a national drug policy’ 2001 [3].  Despite this fact, WHO representative Mr Kees de Joncheere still had to stress the great potential of generics policies and the need to apply these more frequently.

Examples of successful generic policies included Croatia, where a generic price link and reference price system, together with policy measures targeting new medicines, have contributed significant savings to the Croatian Social Insurance in 2009 and 2010.

Countries such as Ireland, Portugal and Spain were highlighted as needing to implement a bundle of measures in order to respond to the global financial crisis. Previously, Portugal’s pricing system for generics set a reference price, i.e. reimbursement amount within a cluster of medicines of identical active ingredient, dosage and pharmaceutical form; defined by the highest priced generics in the cluster. This system was criticized as a lost opportunity for savings. This was evidenced by Portugal being the only country in the EU to have higher generics market shares in value than in volume, which is an indicator of a high price level of generic medicines. In 2010, however, Portugal redefined the reference price as being the average of the five cheapest generics, which has led to generics shares becoming lower in value than in volume.

Strategies to enhance generics prescribing were also discussed. Appropriate medicines policies are key to enhancing generics uptake. Some of the policies being used in European countries included education and regular publications supporting generics, financial incentives for physicians to prescribe generics, mandatory international non-proprietary name prescribing and low generics prices.

An element that perhaps did not receive sufficient attention was that of ensuring public and professional confidence in the quality of generics approved by national or regional medicines regulatory authorities. This may not be a big challenge in Europe, however, in many other countries, a lack of transparency about medicines approval processes feeds both corruption and a lack of confidence in generics. Public access to an electronic medicines register that discloses the basis for generics approval would improve confidence in generic medicines.

WHO concluded that ‘generic[s] policies appear not to be fully exploited yet. At the PPRI Conference, generics were identified as one area where competition works. There is common understanding that savings from generics might be invested for funding innovation. However, as evidence on generics penetration across the countries demonstrated, generics uptake could be improved by more consistent generic[s] policies.’

Generics policies are critical in ensuring access to affordable medicines, but poorly designed and implemented policies can hamper generics from taking a significant market share, and thus reduce the ability of governments to achieve affordable health coverage for everyone.

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Related articles

Medicines pricing policies in Europe: a review

International trends in generics: the EU

References

1.  Zimmermann N, Vogler S. The potential of generics policies: more room for exploitation–PPRI Conference Report. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(3-4):146-9. doi: 10.5639/gabij.2012.0103-4.030

2.  Gray A. Generics policies–a globally-relevant implementation challenge. Generics and Biosimilars Initiative Journal (GaBI Journal). 2012;1(3-4):113-4. doi: 10.5639/gabij.2012.0103-4.027

3.  World Health Organization [homepage on the Internet]. How to develop and implement a national drug policy. 2nd ed. Geneva: World Health Organization; 2001. [cited 2013 Feb 15]. Available from: http://apps.who.int/medicinedocs/en/d/Js2283e/

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