In July the German Federal Ministry of Health 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.
The German industry associations, including EUCOPE member associations BPI and BioDeutschland, have, in general, welcomed several of the proposed amendments, for example that:
- the internal reference price system shall reflect the specificities of antibiotics, i.e. the occurrence of antimicrobial resistance (Sect. 35, subs. 1, sentence 3 Social Code Book Volume V – “SGB V” – as proposed in the draft bill);
- if new improved scientific data is available, pharmaceutical companies should be entitled to request a new early benefit assessment within one year (Sect. 35a, subs. 5, sentences 5 und 6 SGB V);
- the reimbursement for companion diagnostics shall be facilitated (Sect. 87, subs. 2a, sentence 12 and subs. 5b sentences 5 and 6 SGB V);
- reimbursable amounts negotiated between companies and the payers shall not be published but only made available to public bodies that require this information “to fulfil their legal obligations” (although the draft lacks a definition what these legal obligations could be, c.f. Sect. 130b, subs.1b SGB V)
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 particularly 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.
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 patient access to new and innovative medicines.
The industry also considers the proposed wording regarding a benefit assessment for medicinal products with known active compounds to be critical. The bill anticipates that the Joint Federal Committee can initiate a benefit assessment if the product is authorised with a new indication that differs significantly from an earlier authorisation. Since the draft does not define what is meant by “significant differences” but leaves this to the Joint Federal Committee, it is feared that this wording will lead to a wide application of this rule which was agreed during the pharma-dialogue to cover only very few cases.
It has now to be seen how the draft bill will be amended before the Ministry will initiate the parliamentary legislative process. EUCOPE will keep EMIG informed of developments and we will circulate the Membership.