Paragraph 130a(8) of the SGB V allows health insurance funds and pharmaceutical companies to conclude framework rebate agreements for the medicinal products to be supplied at the expense of statutory health insurance funds. With regard to the relevant public procurement legislation, there is a regular process of active-related, formal procurement procedures under the regulations of Part 4 of the GWB by DAK-Health.
DAK-Health assumes that this procedure does not fall within the scope of ‘antitrust procurement law’ (4th part of the GWB § 97 et seq.) because of the contract value of less than EUR 207000 and the absence of a selection decision and therefore the non-discriminatory access of all pharmaceutical companies. Publication in the EU Notice Portal (i.e. in TED) is on a purely voluntary basis.
However, for medicinal products relating to the above active ingredient (Hydrocortisone, ATC D07AA02) to be specified by the tenderer in Annex 2 to the contract, DAK-Health intends to conclude pharmaceutical discount agreements with as far as possible all pharmaceutical companies, at least all interested pharmaceutical companies, until the entry into force of new drug rebate agreements. A discount contract under the authorisation model enters into force for the first time on 1 February 2016 and ends on 31 January 2018 at the latest. Irrespective of this, it automatically ends with the entry into force of the exclusive contract on the above active substance following a formal procurement procedure under the rules of Part 4 of the GWB with one or more contracting parties. In order to take into account the diversity of potential contractors under the marketing authorisation model, each pharmaceutical company will be able to conclude a framework contract at any time and under the same conditions during the contract period. The contractual documents required for this purpose can be requested via the following e-mail address: vergabestelle@dak.de
The following supporting documents/declarations/annexes must be sent in full and in good time (available on request from the above contact point: vergabestelle@dak.de) to the DAK health contact person listed below:
1st letter of tender.
2. Recent proof of enrolment in the professional or trade register (not older than 6 months in the case of dispatch) in accordance with the legislation of the country in which the company is established, e.g. current extract from the trade register; Copy is sufficient.
3. Self-declaration by the company that none of the exclusion criteria laid down in Section 6(5)(a) to (e) of the VOL/A applies. To this end, Annex A1 of the Conditions of Application must be signed, stamped and submitted in the original with the tender.
4. Self-declaration that medicinal products for which the interested party wishes to conclude a contract in the context of this procedure are subject to a marketing authorisation under the law on medicinal products and that the tenderer is entitled to sell to start the contract. To this end, Annex A2 of the Conditions of Application must be signed, stamped and submitted in original with the tender.
5. Acceptance of the contractual requirements of DAK-Health, in particular the discounts laid down, by signing the company stamped contract (3 originals) by the interested party in the proposed place.
6. Completed Annexes 1 and 2 to the contract (three copies each). The interested party must register the medicinal products relating to the above active ingredient, which are to be the subject of the contract.
DAK-Health has published a so-called prequalification procedure for pharmaceutical companies through the European publication platform for simplified participation in future drug discounts (EU Notice 2015/S 105-190319 of 3.6.2015).
Provided that the tenderer has received an effective prequalification decision from DAK-Health in good time before the submission of the documents, he is no longer required to attach the company-related evidence of aptitude (proof of enrolment in the professional or trade register, self-declaration by the company that none of the exclusion criteria laid down in Section 6(4) and (6) of the VOL/A-EG, health certificate from the statutory health insurance fund) together with a copy of the prequalification decision. Annex A2 shall in all cases be attached.
Accordingly, the prequalification notice of DAK-Health also serves as evidence in open-house procedures for DAK-Health, irrespective of the value of the contract.
Documents must be submitted by post to:
DAK-Health, Dr Claudia Heilig (0032 50), Nagelsweg 27-31, 20097 Hamburg.
Annex 2 should also be sent as an Excel file to am_rabattvertraege@dak.de at the same time.
Contracts under this model and for the above-mentioned active substance will be concluded for the first time with effect from 1 February 2016. Interested parties wishing to become contractors on this date must submit the above documents to the above-mentioned body by the 5th of the previous month. Timely access to health in DAC matters. Subsequent accessions are possible at any time. In order to be able to accede to the first or fifteenth of the following month during the period of validity of the contract, the documents referred to above must be available to DAK health by the 5th of the previous month, irrespective of the requested accession. Timely access to health in DAC is also important in this regard.
Example: The tenderer’s request for accession should take place on 15 July 20xx (follow-up month), and the documents must be available by 5 June 20xx (previous month).
Note: This publication will be done using the Open Procedure Form. As already made clear, this is not the case – the notice had to be used for technical reasons, as there is no suitable form for authorisation procedures.
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