Generic Medicines

Introduction to generics

You can think of a generic medication or “generic” as a copy.

While overly simplistic, let’s use bottled water as a comparison.

Volvic create a bottled water product and become known as the brand leader. They run adverts on TV and radio and have posters scattered around selling their product. Some time later, other supermarkets like Tesco and Spar create their own versions and sell them for a lower price. While differences may exist in the appearance, packaging or taste, both bottles of water hydrate you in the same way.

How generics come about

In the pharmaceutical industry, a company will spend years and billions of euro discovering a new drug. A new drug has to be tested and trialled rigorously and its “recipe” changed until it is safe for humans to take. It then has to be marketed as a brand to the medical professional and public in some countries. Because the company has spent so much money before the drug is even sold, they are given a patent for 8-10 years usually during which time no other company can make the same product. This time is used to recoup the money they invested in launching the new drug.

Once this patent expires, other drug manufacturers are free to make the product and are given access to the original “recipe” which they can then copy into “generic” versions of their own. Generic versions are much cheaper to make as the company making them doesn’t have to carry out the same research as the original company did.

How generics are regulated

All medicines for sale in Ireland are regulated by the Health Products Regulatory Authority (HPRA). Irrespective of whether a medication is for sale in another country already, all products must be shown to the HPRA to be safe before they are granted a license for sale in Ireland (Marketing Authorisation).

The same applies to generic medications. While the branded product may already be licensed for sale by the HPRA, each and every generic manufacturer must demonstrate that their version has the same effect on the body as the branded original does.

How generics can differ from the branded version

While generic medications must have the same effect on the body as the branded product and contain the exact same amount of drug or “active ingredient”, there may still be slight differences.

The following are some differences you may notice:

• Different colour tablet/capsule
• Different taste
• Tablet instead of a capsule or vice-versa