A review of the market and trends in Europe and North America revealed that the majority of medicines consumed in Canada, Europe and the US are generics. Biosimilars were also highlighted as being key to increase patients’ access to innovative treatments. Trends for the generics market in Canada, Europe and North America were the increased uptake of generics and cost reductions, as well as the consolidation and globalization of generics companies.

The importance for Europe to adopt a manufacturing provision allowing generics companies to develop their products during the period covered by the Supplementary Protection Certificate (SPC) was highlighted. Other intellectual property topics covered were settlements between brand-name and generics companies and patent pools.

A review of the market and trends in Asia showed China to be one of the most significant markets for off-patent originators and generics. A review of the market and trends in emerging markets such as Brazil and Mexico showed the high use of generics and the great potential for biosimilars in these countries. A review of the Middle East showed how inequities in healthcare provisions contributed to the Arab Spring.

The importance of using an international approach in order to ensure the quality of starting materials for pharmaceuticals was highlighted. How regulatory agencies, such as EMA and FDA, were working towards increased cooperation and convergence of regulatory processes was outlined. The actions of International Generic Drug Regulators (IGDRP) to foster international collaboration and convergence of regulations was discussed. The willingness of Europe to adopt an ‘information-sharing’ model and accept data from Competent Authorities from third countries was also presented.

Finally, the impact of trade agreements on generics was discussed. In most cases these trade agreements were seen to have a negative impact, in that they generally increased patent protection for brand-name drugs, delaying the introduction of generics.

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