Regulatory framework and market access of generic medicines in the European Union

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

M. Alekya

Posters: Pharmaceut Reg Affairs

Abstract :

Generic medicines have become essential contributes for government in their effort to contain public health care budgets. Generic medicines are substitutes for originator medicines with the same quality, safety and efficacy. Prices of generic medicines tend to be 10-80% lower than those of innovator medicines so any delay constitutes a missed opportunity for savings to health care budgets and for access to health care for patients. They can enter the market when all protection on the originator medicine has expired which are protected by patents and exclusivity to reward the inventor for dissemination of the details of their invention. In addition to patents, market protection can be extended for other reasons such as supplementary protection certificates, data and marketing exclusivity. The reasons for delay of market access for generic medicines in Europe are their regulatory frame work, pricing and reimbursement of pharmaceuticals. The establishment of a unitary European Union patent together with a unified and specialized patent litigation system, the reduction of backlogs in national agencies, avoiding third party interventions as much as possible and automatic approval of pricing and reimbursement status upon marketing authorization approval of the generic medicines are few polices which would enhance market access of generic medicines in the EU.

Biography :

M.Alekya has completed her B. Pharmacy from St. Ann?s College of Pharmacy, Vizinagram and v M.Sc. Regulatory Affairs from Manipal College of Pharmacy, Manipal University, Karnataka. She did poster presentations in several college competition including IPC.