I’ve made no secret of my recent challenges with mental health but when my drugs failed to pick me up like they had done in the past I fought back and did some research into why. I’d been on a low dose of generic medication for ages and never had a problem with them so I was truly puzzled as to why they weren’t working when I really needed them.
We’ve all been told by our Dept of Health, doctors and pharmacists that generic medications are the same as branded but cheaper. I endeavored to dig a little deeper. I wanted evidence.
As you may know once a medication patent expires, a bunch of different companies can jump on the bandwagon and try to make that same medication to flood the market with cheaper product. They didn’t undergo the cost of research & development, clinical trials, new product marketing and the like so it’s understandable they can sell it at a lower price. So what’s the problem, they’re the same right? Well, yes and no.
Directive 2001/83/EC, Article 10(2)(b) defines a generic medicinal product as a product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance are considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy. Furthermore, the various immediate-release oral pharmaceutical forms shall be considered to be one and the same pharmaceutical form.
I’m focusing on drugs that are pitched within Europe with the same dosage and delivered orally only, as these are the most common and this was what was potentially affecting me. That said, the rules for USA and Australia seem at a glance to be identical.
Firstly, the generic manufacturer must adhere to the same requirements with respect to clean production area, traceability, packaging & labeling, submissions, market authorisation, business conduct standards, etc. I’d expect nothing less.
Secondly they must perform what’s called a bioequivalence study. This study will prove that the drug is in fact the same as the branded one. There are specific rules with respect to eating and drinking before and after test times, duration between sampling, methods of collection and so on. This is also quite normal. The subjects within this study must be healthy and suitable for evaluation naturally enough. The number of subjects required is 12 at a minimum. Is this an usually low number to you? It certainly is to me but let’s continue.
For generic medications there is no need to show efficacy. This means the generic manufacturer isn’t required to show that the drug actually treats what it’s sold to treat. Then again, these tests were completed by the patent holder for the branded drug and this generic is the same so why would they need to redo these tests.
I think it is also worth mentioning that if a number of different dosages are being applied for, it may be permitted to perform this study for just one strength. This isn’t ideal but not a dealbreaker either.
The molecule must be mostly the same. It doesn’t need to be identical in any instance. Slight differences are permitted. It must be designed to treat the same condition/ailment as the branded drug and it must pass the following mathematical tests (usually taken from blood or plasma):
- The concentration of drug circulating in the body (normally measured in plasma or blood) over a period of time.
- The maximum concentration of the drug in the body.
What is required is that the readings from the generic drug match the branded drug to within 80% to 125% for both tests. That’s a pretty broad range for something that’s supposed to be identical.
And that’s not all. It doesn’t even need that the generic drug company satisfy this exactly. They only need to provide 90% confidence that their results fall within the 80-125% band. There are some exceptions to these rules, such as drugs that rely on rapid release.
In summary, there’s a good chance you’re taking a generic medication whereby the molecule must be similar; the dosage you’re on might have been tested; the concentration needs to be in or around what is asked of it; the length of time it stays in your bloodstream should be roughly the same; it was tested on at least 12 people and there’s no requirement at all that it does exactly what it says on the box.
I don’t know about you, but in my eyes, that doesn’t equate to the same drug and I’ve returned to branded drugs. I refuse to put a price tag on my mental health.
Research gathered from Directive 2001/83/EC, Article 10(2)(b) and European Medicines Agency Doc. Ref.: CPMP/EWP/QWP/1401/98 Rev. 1/ Corr.