Pharmaceutical companies to pay significant fees for state evaluation of their medicines 10 Oct 2018

A recent joint decision (No. 58584/02.08.2018) of the Ministers of Finance and Health obliges pharmaceutical companies to incur significant charges so that the recently established Committee for the evaluation and reimbursement of medicines (Health Technology Assessment- HTA) completes the procedure for the evaluation of their products.

The said Committee (Evaluation Committee) was introduced under Law 4512/2018. Its main purpose is to evaluate medicines which have received a marketing authorization and are marketed in Greece, on the basis of, amongst others, their medical need and therapeutic benefit in order to include them in the positive list of reimbursed medicines.

The evaluation process commences with the submission to the Committee of a relevant application by the pharmaceutical company/marketing authorisation holder which includes the complete file of the product (documentation and information). The Committee’s opinion re. the medicine is addressed to the Minister of Health, who decides upon the insertion (or omission) of a medicines to the positive list of reimbursed medicines. In order to evaluate whether the entry of a medicine to the positive list of reimbursed medicines will have an impact on the state budget, the Evaluation Committee forwards the applications which have been (initially) granted a positive evaluation, to a Negotiation Committee.  The latter negotiates the price of the reimbursed products with the pharmaceutical companies, so as to define the price that each medicine should be granted at the reimbursement medicines’ system.

Under the above mentioned ministerial decision pharmaceutical companies are called to pay the following fees:

a) For on-patent products: 5.000 € per pack unit.

b) For generic products: 3.000 € per pack unit.

c) For re-evaluation of medicines that are already included in the positive list of reimbursed medicines: 2.000 € per pack unit.

d) For re-evaluation following a negative decision by the Committee: 1.000 € per pack unit. In such case, companies may re-submit their file after approx. 6 months as from the issuance of the negative decision.

The payment of the above mentioned fees is necessary for the commencement of the evaluation process.

Pharmaceutical companies have apparently expressed concerns that the above fees may be high and/or disproportionate, as well as doubts whether the evaluation procedure will not be time consuming and resulting to delays in the inclusion of products to the positive list of reimbursed medicines. This remains to be seen.