ACCESSING THE PHARMACEUTICAL MARKETS OF BRAZIL, RUSSIA, INDIA AND CHINA

Author(s)

Faria-Billinton EC*1;Murray GC1;Raza SA2;Grubert N3, Pickering L4 1Abacus International, Manchester, United Kingdom, 2Abacus International, East Delhi, India, 3Decision Resources, London, United Kingdom, 4Decision Resources, Burlington, MA, USA

While pharmaceutical sales in mature economies are declining, in emerging markets they have been expanding rapidly, with growth rates in double figures. Here we focus on market access in BRIC (Brazil, Russia, India and China) which together represent just over 40% of the world population. OBJECTIVES: To identify the processes and key stakeholders involved in gaining market access in BRIC; to assess the importance of health technology assessment (HTA) in gaining reimbursement in these countries; to identify opportunities and challenges to market access. METHODS: A review was conducted to identify the current processes and key stakeholders in market access in the BRIC countries and to identify favourable and unfavourable factors to market access. RESULTS: The licensing and reimbursement processes vary in the BRIC countries. Brazil follows processes similar to those in Western Europe, including HTA and public consultation as part of the reimbursement application. In China, the licensing process can take 4-6 years, though fast-tracking for innovative drugs has recently been introduced. Russia, China and India do not yet rely on HTA for reimbursement decisions. In India plans to use “pharmacoeconomic principles” in setting prices of new molecules have been announced. Opportunities in all these countries result from increasing affluence and life expectancy and the diseases associated with these. Some challenges to market access are: poor IP protection; protectionist measures; compulsory licensing; drive to use generics or biosimilars, often produced locally; price controls; variable health insurance/NHS coverage; and limited budgets for prescription drugs. CONCLUSIONS: HTA is now common practice in Brazil, but not yet in Russia, India or China. Although demand for new drugs is increasing in these markets, protectionism measures, competition from generics and budget constraints due to the increased burden and requirement for new high priced drugs present a challenge when accessing the pharmaceutical market in BRIC countries.

Conference/Value in Health Info

2013-11, ISPOR Europe 2013, The Convention Centre Dublin

Value in Health, Vol. 16, No. 7 (November 2013)

Code

PHP137

Topic

Health Policy & Regulatory

Topic Subcategory

Reimbursement & Access Policy

Disease

Multiple Diseases

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