In July the German Federal Ministry of Health has sent a draft bill concerning changes to the market access and pricing legislation for pharmaceuticals (Gesetz zur Stärkung der Arzneimittelversorgung in der GKV) to other ministries and industry associations. The German industry associations had the opportunity to comment on the draft bill until 15 August. In addition, a hearing of the relevant stakeholders and other experts at the Ministry is scheduled for 23 August.
One of the main concerns from the industry stakeholders’ perspective is the fact that the draft includes proposals that have never been discussed during the pharma-dialogue meetings. This holds in particular true for the extension of the price moratorium until the end of 2022 which basically keeps the prices for pharmaceuticals at the level of 2009. The extension of this price freeze has been largely criticised by the industry. Although the introduction of a compensation for inflation is generally welcomed, according to the industry stakeholders, this measure is not sufficient to balance the losses incurred since the introduction of the price freeze in 2010.
The industry stakeholders also criticise the Ministry’s plan to alter the principle of free pricing in the first year and to introduce a revenue threshold of EUR 250 million. If this threshold is exceeded within the first twelve months, the price negotiated between the manufacturer and the National Association of Statutory Health Insurance Funds will apply retrospectively as of the first month following the month in which the threshold was exceeded. According to the German industry associations’ points of view such an amendment would contradict the original purpose of the principle of free pricing in the first year, namely to guarantee swift patients’ access to new and innovative medicines.