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A sustainable generics industry in the EU Posted 19/08/2011

Today, generic medicines play an essential role in treating disease by increasing the accessibility and affordability of modern day pharmaceuticals. It is therefore essential to ensure that generics can enter the market as soon as possible after patent and data exclusivity protections expire and compete effectively in order to maintain a sustainable generics industry.

The three pillars for obtaining such a sustainable generics industry are as follows:

Fair access to market

 

  • No hurdles to entry after patent/data exclusivity expiry
  • Efficient EU regulatory framework

 

Fair pricing

 

  • Profitability
  • Affordability
  • Savings

 

Fair competition

 

  • Stimulate market competition
  • Ban anti-competitive behaviours

 

The long-term sustainability of the generic medicines sector relies on fair prices and a level playing field. Acceptable margins across the entire generic medicines supply chain will be essential if their full value is to be realised. It is important to increase patient access to generic medicines and there are many benefits to be gained from their faster uptake. Treating them solely as a cost-saving mechanism will serve only to stifle their ability to deliver continued benefits long-term.

Generic medicines provide an opportunity to obtain similar treatments at lower costs for patients and payers, while liberating budgets for financing new innovative medicines. However, in order to achieve these benefits there needs to be a level playing field and governmental policies which maintain a sustainable generics industry.

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Generic drugs – registration, quality, value and sustainability

The role of generic drugs in the EU

Registration procedures for generic drugs in the EU

Quality control for generic drugs

Generic applications in the EU, patents and exclusivity

Source: EGA, IMS Health

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