The Case of Generic Medicines


Developing a medicine costs money, which companies must gain back by selling it. But medicines must be available to those in need regardless of their price. This is why governments allow bioequivalent medicines; but can we ask for a better option?


| Otho Mantegazza


Research and Development (R&D) of pharmaceutical drugs has costs:

  • It costs money - to buy and maintain structures and materials needed for pharmaceutical research, to cover for the pitfalls and dead ends that are unavoidable in the R&D process, and to pay and assure the well being of all people that work on it.
  • It costs human intellect and human labour - because people dedicate their focus and their time to it. And this process can be long, challenging and often unrewarding.
  • It has costs for the environment and for animal and human welfare - because research uses resources, it wastes plastics and harsh chemicals, and, it harms animals for our well being. And in the last stages, it also uses human subjects in clinical trials.

How to justify these costs? Once research is done, as a society we must make it worth. We must make sure that the medicines generated by this research reach everyone in need. We must make sure that every single detail, generated by research, reaches those that prescribe that medicine and those who take it, so that they know how it acts, when it is helpful and when it is not.

The interests of the companies that invest in R&D, and of the citizen/patients are mediated (in Europe) by the European Medicines Agency (EMA). This agency supervises and advises a network of regulatory bodies at the European and at the State level, setting guidelines for the R&D, marketing and safe use of medicines.

To gain back their monetary investments, innovating companies (the companies that develops the medicine) are granted exclusive rights to market a medicine for a certain period. Those rights are granted through patents and to the Data/Market Exclusivity Periods. Patents rights last up to 20 years since patent application is filed, but patent application often must be filed years before is deemed safe to access the market. The Data and Market Exclusivity period, instead, are granted for 8 + 2 years since the new drug is allowed to enter the market. Which of the two expires last determines for how long the innovating company has exclusive rights to the market.

Afterwards, others are free to produce and market the medicine as generic medicines. Those medicine come at lower price because their price does not have to cover for the cost of R&D and extensive trials. In a further attempt to lower the price of medicines, generic medicines are considered safe and helpful on the basis of bioequivalence.

Bioequivalence is a compromise among:

  • getting medicines on the market at low price,
  • limit animal and patient testing,
  • assuring the safety of patients.

The basic concept of bioequivalency is that two medicines are interchangeable if they release their active component in the blood of patients with the same kinetics.

Although this is a very reasonable assumption, and one that is tightly regulated and constantly checked by the EMA. I have found it hard to understand why regulatory bodies settled for bioequivalence instead of also requiring equivalence of the production process and full medicine formulation. Medicine seems too important to introduce unwanted variables.

While generics bioequivalents has succeeded around the world in bringing to the market reliable medicines at lower prices, they have not always been up to standards. A better way to make worth the research and environmental costs that come with developing a medicine, would be to make available the exact same medicine at lower price once the R&D investments have been covered.

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