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Supplementary protection certificates: highly profitable for drug companies

A European scheme enables pharmaceutical companies to prolong their market monopoly, sometimes unjustifiably, to the detriment of social welfare systems.

In the European Union, the supplementary protection certificate scheme is one of a range of industrial protection mechanisms that includes patents.

These certificates enable companies to extend their market monopoly by up to five years beyond the 20 years of protection afforded by a patent. They were introduced in the early 1990s primarily because the increasingly long period between filing a drug patent and obtaining marketing authorisation was making "the period of effective protection under the patent insufficient to cover the investment put into the research".

Things have changed since then however, and several studies have shown that pharmaceutical companies actually recoup their investment very quickly, especially on cancer drugs, because research and development (R&D) times have shortened considerably in recent years and because drugs are sold at such high prices.

In 2017, a report commissioned and published by the European Commission showed that pharmaceutical companies make such extensive use of this mechanism that 86% of drugs were granted a supplementary protection certificate between 2010 and 2016.

Prolonging a pharmaceutical company's monopoly has serious consequences: it delays the market entry of cheaper generic drugs, penalising both patients and social welfare systems. The fact that a number of "blockbuster" drugs (such as Sovaldi° (sofosbuvir), Glivec° (imatinib) and Herceptin° (trastuzumab)) received supplementary protection certificates shows that this mechanism is too permissive and must be reformed, with only drugs that are not very profitable for pharmaceutical companies in the short term being eligible.

©Prescrire 1 October 2021

Source: "Supplementary protection certificates: an industrial protection mechanism, highly profitable for drug companies " Prescrire International 2021; 30 (230): 249-250. Subscribers only.

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See also:

"Industrial protectionism
and drugs: too many
negative effects"
Prescrire Int 2019;
28 (209): 275-277.
Pdf, subscribers only

"Pharmaceutical companies:
profit above all else"
Prescrire Int 2018;
27 (196): 222-223.
Pdf, subscribers only

"Cancer drugs: very
profitable for drug
companies"
Prescrire Int 2020;
29 (211): 27.
Pdf, free


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