COMPULSORY LICENSES FOR NON-COMMUNICABLE DISEASES- IMPLICATIONS FOR PHARMACEUTICAL PRICING IN LOW-INCOME COUNTRIES

Author(s)

Wasserman M1, Priest VL21Double Helix Consulting, London, United Kingdom, 2Double Helix Consulting, Asia-Pacific, Singapore, Singapore

OBJECTIVES: The signing of the TRIPS agreement in 1995 and Doha Declaration in 2001 have allowed low and middle-income countries to issue compulsory licenses (CLs) for medicines in times of national emergency.  While normally for infectious diseases, given the epidemiologic transition occurring in these countries along with the development of insurance systems, it is likely that the trend in the next decade will be towards a higher demand for more expensive medicines to treat non-communicable diseases (NCDs). We sought to determine the impact of CLs for medicines that treat NCDs and make recommendations as to how pharmaceutical companies and governments can work together in the future.    METHODS: We analysed a series of cases where a CL was issued, or the manufacturer successfully negotiated to retain patent rights for drugs treating NCDs to determine the relative impact of the CL or negotiations, prices were benchmarked and compared before and after CL issuance in 2012 US dollars using the medical commodities consumer price index and relevant exchange rates. RESULTS: Of nine CL cases identified, six resulted in an issued license, two were withdrawn, and one was negotiated and resulted in a discount and cost sharing agreement.  For licenses issued, the average price reduction was 86.2% and supply was issued to a generics manufacturer.  Roche recently decreased the prices of three of its products by an average of 91.0% in India - indicating there may be a trend to reducing price in order to protect patent rights and avoid CL issuance. CONCLUSIONS: Low-income countries are increasingly using CLs to obtain lower prices for medicines to treat NCDs. Price negotiation tended to result in a greater price decrease than issued CLs, highlighting the importance placed on retaining patent rights. Pharma companies could consider proactively seeking cost-sharing arrangements to provide access to low-income patients and maintain market exclusivity.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PHP55

Topic

Health Service Delivery & Process of Care

Topic Subcategory

Prescribing Behavior

Disease

Multiple Diseases

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