Patent protection for pharmaceuticals
Newly developed drugs are protected by patents for twenty years. Within this period, the pharmaceutical company may exclusively sell its original preparation and determine its price.
Patent protection can only be extended through certain procedures, such as conducting pediatric studies or applying for a special protection certificate.
After patent protection expires, the manufacturer of the original drug must publish its research results on the active ingredient in question. Other manufacturers can then also produce the active ingredient on the basis of this information and bring it to market as a generic.
There are now one or more generics for almost every drug whose patent protection has expired. This applies both to over-the-counter preparations such as mild headache remedies and to prescription drugs such as preparations for high blood pressure, kidney weakness, diabetes or even cancer.
Are generics therapeutically equivalent to the original?
Accordingly, generic and original products are considered bioequivalent – i.e. therapeutically equivalent – if the human body absorbs the active ingredient from the generic product at approximately the same rate and in approximately the same quantity as that from the original product (bioavailability).
In practice, the deviation for most imitation preparations is about five percent.
In many cases, this small deviation does not play a major role. For some drugs, however, the exact rate of action is important. In these cases, the authorities can set the tolerance range more narrowly.
Other changes may result, for example, from the ingredients used. If no lactose was used as an excipient in the original, this may be the case in the generic and vice versa. This may result in intolerance reactions or, conversely, better tolerability.
Dosage form
Are there differences between generic and original?
Differences between a generic and its originator product may exist in the excipients added (e.g. preservatives and colorants) and in the manufacturing process. Further development of the added excipients and/or the manufacturing process may improve the generic preparation in some respects.
The active ingredient is then not released quickly and in one go, but slowly and continuously. This results in a constant level of active ingredient. In such cases, however, the generic drug must undergo extensive clinical trials in humans before it is approved, just like the original.
Why are generics cheaper than originals?
The approval of a generic drug is also much less expensive: bioequivalence tests, such as those required for generics, are significantly less complex and much cheaper than the clinical trials that the original drug has to undergo.
Overall, therefore, generic suppliers have to invest much less money in their product than the manufacturer of the original drug. They can therefore also offer it at a much lower price.
Savings in the healthcare system
In Germany, generic drugs now cover 75 percent of the total pharmaceutical requirements of the statutory health insurance funds (GKV), but account for less than ten percent of pharmaceutical expenditure. So when doctors prescribe less expensive generics instead of the original drugs, this means savings for the health insurance funds and a reduction in the burden on the healthcare system.
If a physician checks the “Aut-idem” box on a drug prescription, the pharmacist can dispense a less expensive alternative preparation to the patient instead of the prescribed (original) drug.
This preparation must contain the same active ingredient as the prescribed drug and have the same strength and package size. It must also be approved for the same area of application and have the same or a comparable dosage form.
In addition, the reference price regulation for prescription drugs is also aimed at curbing the enormous increase in pharmaceutical expenditure. For certain groups of active ingredients (e.g. beta blockers, statins), maximum amounts have been set which are reimbursed by the statutory health insurance funds.
If the price of a drug exceeds the fixed amount, the insured person must bear the additional costs themselves – in addition to the statutory co-payment that applies anyway.
The exact regulations governing the pricing of pharmaceuticals differ between Germany, Austria and Switzerland, which is why the potential savings described here do not necessarily apply to all three countries.
Disadvantages
However, the – in some cases repeated – change of preparation also carries the risk of medication mix-ups. Medication errors are known to lead to serious side effects, including hospitalization, and in the worst case can even be fatal.
Generic drugs in pediatrics
To date, there are only a few drugs on the market that have been developed and approved specifically for children. Therefore, the little ones mostly take medications that are actually intended for adults – both original preparations and the respective generics.
In Switzerland, since 2018, there have been recommendations on the indications for use (indications), dosage and administration of the active ingredients most commonly used in pediatrics – prepared by the SwissPedDose association on behalf of the Federal Office of Public Health.
In return, in both cases the patent protection is extended by six months (even if the tests on minors are negative and the preparation does not receive approval as a pediatric drug).
Generic drugs, among others, are excluded from this provision. For them, the EU has come up with something different. Pharmaceutical companies can subsequently adapt a drug developed for adults for children (in dose, dosage form, etc.).
In addition, the manufacturer is “rewarded” with ten years of document protection. Other generic suppliers will only be allowed to view the research documents, refer to the studies conducted on minors and copy the children’s product after this period has expired.
In this way, the EU – out of ethical concerns – wants to prevent a second manufacturer from carrying out the same tests on children in order to launch an analogous children’s generic on the market.
Special case of biosimilars
While generics are the copycat preparations of classic chemically-synthesized drugs (such as the painkiller ibuprofen or the cholesterol-lowering drug atorvastatin), biosimilars are copycat preparations of biotechnologically produced drugs (called biologics or biopharmaceuticals).
Because biologics and their imitators, the biosimilars, are produced by living cells, they can never be completely identical, but only as similar as possible (generic drugs, on the other hand, are an identical copy of their original). For this reason, biologics must not simply be replaced by their biosimilars – such a change in therapy is always accompanied and monitored by a physician.
Only when this has been proven is it possible to draw on existing studies and data as well as experience gained – in this case, the studies conducted with the originator cannot be repeated in their entirety.
Overall, therefore, the requirements for biosimilars are much greater than for generics.
You can read more about biotechnological drugs and their imitation preparations in the article “Biopharmaceuticals & Biosimilars”.
