German Pharmadialog Updates

Regarding the finalisation of the Pharmadialog, a series of meetings between the pharmaceutical industry and Germany’s coalition government earlier this year, please note that the German Federal Ministry of Health has proposed numerous changes to existing legal regulations in a concept paper in order to implement the results of these meetings.

The most important aspects are as follows:

  • The price moratorium for pharmaceutical companies will be extended until the end of 2022. From 2018, however, a compensation for inflation will be introduced which was one of the industry’s main demands. The Ministry expects savings of 1.5 to two billion euros from the extension of the price moratorium.
  • While, in general, the first year of free pricing will be maintained, the Ministry is planning to introduce a revenue threshold. If this threshold is exceeded in the first year, the negotiated price will retroactively apply from the month following the excess of the threshold. However, the level of this threshold is still unclear. In the EUCOPE view, it is essential that the application of the threshold provision will be a true exception rather than becoming the rule.
  • Under certain circumstances, it will be possible for the G-BA to arrange for a benefit assessment for medicinal products with known active compounds, namely, when the authorisation of a new indication is sought that is substantially different from the first indication. The Ministry has underlined that such a requirement will only apply under very specific conditions and it is vital that these conditions are clearly defined to give the industry the necessary legal certainty.
  • The Ministry is also committed not to make the negotiated price publicly available. By forgoing the publication of this price, the Ministry also satisfies a demand vital to the pharmaceutical industry and acknowledges the possible negative impact of such a publication for international reference pricing purposes. The agreed price shall only be available to those public bodies that require this information “to fulfil their legal obligations.”
  • The Ministry has also announced tighter sanctions in cases where companies do not submit complete dossiers to the G-BA. The concept paper anticipates that, where the dossier does not prove any additional benefit or where no dossier is submitted, the reimbursable amount will be below the annual treatment costs of the comparator therapy.
  • The concept paper does not mention any changes to the rules for the benefit assessment of OMPs, i.e. that the G-BA determines the extent of additional benefit for OMPs with revenues not exceeding 50 million euros based on market authorisation and its substantiating studies.

Another outcome of the Pharmadialog is the focus on the fight against the progressive development of resistance in antibiotics. To promote an accurate use of antibiotics, the Ministry proposes to improve the provisions concerning the reimbursement of diagnostic methods. In addition, the G-BA shall be enabled to take into account the specific resistance when assessing the benefit of antibiotics.

Whereas the concept paper incorporates some of the demands of the industry, other envisaged measures are less clear and it remains to be seen how the actual legislative proposals look.

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Published 20. July 2016 in News Germany