Our ageing population coupled with the desire to reduce healthcare spending are the factors behind the growth of the global generics industry. Access to high quality, affordable treatment options is more critical than ever.
Generic pharmaceuticals are marketed after the patent protection on the originator’s brand medicine has expired. They are the same as existing approved brand-name medicines in active ingredient, dosage form, safety, strength, route of administration, quality and performance characteristics. Generic medications are just as safe and effective as their brand-name counterparts, and often cost less. However, the colour, size or shape could be different from the originator and they will come in different packaging.
As stated by Ireland’s Health Service Executive: “The regulatory authority, the [Health Products Regulatory Authority] (HPRA), monitors the safety of medicines available in Ireland. The IMB aims to make sure that all medicines on the Irish market are safe, effective and high quality.”1
Learn more about generic medicines on the Health Service Executive website.
In Ireland, the European Medicines Agency along with the Health Products Regulatory Authority (HPRA) follow a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications:
- Contain the same active/key ingredient
- Have the same strength
- Use the same dosage form (for instance, a tablet, capsule, or liquid) and
- Use the same route of administration (for instance, oral, topical, or injectable).
- The HPRA's review process also ensures that generic medications perform the same way in the human body and have the same intended use as the name brand medication. Healthcare professionals and consumers can be assured that HPRA-approved generic products have met the same rigid manufacturing standards as the innovator medicine. In addition, HPRA inspects facilities to make certain the generic manufacturing, packaging, and testing sites pass the same quality standards as those of brand-name medicines.
Ireland introduced compulsory generic substitution in 2013 with the aim to “ensure value for money in the supply of medicines” so that “lower prices are paid for these medicines resulting in further savings to both taxpayers and patients”.2 Since then healthcare professionals and patients more readily accept generic medicines as a safe, effective and less expensive alternative to a branded product.
Moreover, according to Medicines for Ireland - the country’s pharmaceutical industry association - generic medicine usage in the country was at 11% in 2013 and in 2018 that figure increased to 58%, saving the Irish healthcare system an estimated €1.6 billion in medicines spend.3
Branded generics are generic medicines that have been given a different brand name than the reference product.
Mylan markets branded generic prescription medicines in Ireland after approval by the appropriate health authorities.
Investing in R&D and Manufacturing
Makers of generic medicines do invest significant sums in R&D and in manufacturing capacity. But because generics developers are not required to reproduce expensive clinical trials and do not engage in product promotion, generic medicines typically cost far less than brand-name medicines.
DOP: July 2020