Generic equivalents ... affordable medicines.

About Generics

The Science of Generic Medicines

Affordability & Sustainable Health

Intellectual Property

Further Resources

“Making Medicines Affordable”

A Video Profile of the European Generic Medicines Industry

Quality Medicines at Competitive Prices: A Profile on Generic Pharmaceuticals

Generic Medicines   —   Affordable Healthcare    

Rory O'Riordan
President, EGA (2002-2004)

Essentially, generic drugs are the same as original medicines. The original product is the first version of a compound introduced on the market, and the generic is the product that is introduced after the patent has expired. The main difference is that generic medicines cost a fraction of the original products, which is good news for governments and good news for patients.

We know what dose is required, we know what dosage form is required, we know the safety, and the efficacy of the product. And therefore we are able to produce these medicines at a much lower cost than the originator products.

There are very strict rules covering the development, the manufacturing and the marketing of these products. They are made in inspected plants under what is called “GMP” or “Good Manufacturing Practice” and meet a very strict level of approval before they are allowed onto the marketplace. And even then they are obliged to be followed up by the marketer in terms of monitoring the number of adverse events that may be reported for the medicine. So they are under exactly the same legislation and protection as original medicinal products.

Greg Perry
Director General, EGA

In the first place, they [generics] provide affordable medicines for our citizens, and that means greater access to medical care for more people in Europe. Secondly, through competition, we provide an incentive for big pharmaceutical companies to create more innovative drugs. If there wasn’t competition in the market, at the end of the day, there wouldn’t be any new drugs or innovation.

Generics medicines are already very important for the old EU-15 Member States, and they are even more so in the new EU-10 Member States where there are severe budgetary problems in the healthcare sector. Generics are absolutely essential to sustaining the healthcare provisions of these countries.

But there is another really important factor. We are about to see an amazing change in the structure of our population. We are going to have a much more elderly population. We have got to consider how we are going to sustain our healthcare systems. And this is a really fundamental role for generic medicines, because it’s through the affordability of generic medicines that we will be able to afford and sustain our healthcare systems in the whole of the European Union.

The future of our industry will depend very much on the regulatory framework that is developed in the European Union for generics. That means the legal framework, whether or not we are going to have excessive intellectual property protection or reasonable intellectual property protection. Whether we have the regulatory system — which is about the authorisation of medicines — whether this will be developed and written in a way which is good for generic medicines. These two factors will very much influence where our industry will be able to go.

Susan De Stasio
Chair, Regulatory & Scientific
Affairs Cte, EGA

From my perspective, the primary benefit of a generic medicine to society is providing a quality, safe and effective, affordable alternative to the originator product to the people of the European Union.

Greg Perry

GP: Society will benefit from a greater number of affordable medicines on the market. That’s great news for society, it’s great news for the healthcare budgets, and it’s great news for the elderly in particular, who use most medicines...

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