IQWiG comments on EMA’s policy on the publication of clinical study reports


IQWiG welcomes the adoption of Policy 0070 as an important step towards an increase in transparency and thus to more reliable benefit assessments of drugs. We are particularly pleased that – in contrast to the procedure planned in May 2014 – the data can be downloaded, saved, and thus processed for non-commercial purposes after all.

However, in the “terms of use” there is still a gap between this approved non-commercial use on the one hand and impermissible (or “unfair”) commercial use on the other. It remains unclear which forms of use by companies are permitted or “fair”.

HTA agencies are explicitly allowed to use the EMA study database. However, this is insufficient: European procedures for benefit assessments require that the drug manufacturers themselves submit dossiers with information for the benefit assessment to HTA agencies. As long as it is unclear whether the use of documents from the EMA study database by competitors can be penalized as “unfair commercial use”, then the potential of the EMA policy with regard to the European procedure for the benefit assessment of drugs will not be exploited. This is because the use of documents from EMA’s study database is important for meaningful comparisons between drugs, particularly for so-called indirect comparisons.

In addition, the policy only regulates the publication of clinical study reports submitted to EMA after 1 January 2015 within the framework of marketing applications. However, data are also required from older studies of drugs that have been available for longer on the market, as well as from studies that are conducted after drug approval. The experience of previous years shows: A voluntary commitment by industry to publish older study data is insufficient. A legal obligation is required.