216 rheumatologists across the country have signed an open letter to health authorities, unhappy that the authorities may remove the need for patient informed consent for treatment with biological/biosimilar medicines.

On November 29, 2022, the National Health Insurance Service (CNAS) published in the transparency of decisions the draft of amendments to Government Resolution No. 696/2021 regarding the approval of service packages and the framework contract.

Under Article 156^1, more than 5,300 patients, including children, with severe rheumatic diseases (rheumatoid arthritis, juvenile idiopathic arthritis, spondyloarthritis, psoriatic arthropathy, systemic vasculitis) currently treated with original biologics will be transferred on April 1. 2023 for biosimilar biologics, eliminating the need to obtain patient informed consent for new treatments as required by current regulations, rheumatologists say.

The exception to obtaining the patient’s informed consent for the treatment he will undergo, proposed by the CNAS and the Ministry of Health, “is a serious violation of medical ethics and deontology, as it eliminates the patient’s legal right to be informed about the existing therapeutic options” for his disease. Currently, the informed consent procedure allows the patient to receive information about the expected benefits of available treatment methods, as well as their potential risks, so that they consciously agree to the recommended treatment, as is also legal, according to the provisions of the Patient Rights Act, rheumatologists believe.

“We, the undersigned, practicing rheumatologists, ask the state authorities, which have authority in the field of public health protection, to ensure compliance with the principles of medical ethics and deontology in the medical activities we carry out, including the protection of the patient’s health. informed consent, as a guarantor of his right to be informed about the treatment recommended by the doctor,” says the open letter.

The letter provides a number of supporting arguments, including:

• Biosimilars are biological therapeutic agents for which the patient’s informed consent must be obtained before prescribing;

• Abolition of the patient’s informed consent procedure is unacceptable from the point of view of medical practice in Romania in 2023, it is against all European principles followed by Romania;

• The current billing mechanism for biologics/biosimilars at 120% of the reference price results in CNAS billing different prices for different biosimilars well above the reference price and leads to the ridiculous situation of having biosimilars for which CNAS sets a higher the price than for the original, or in which the “savings” obtained by CNAS is 9 lei per therapeutic unit;

• The approach to increasing the penetration of biosimilars should be associated with a significant reduction in the price set for them, following the example of other countries such as Denmark, where the authorities received an 83% reduction in the cost of biosimilars in exchange for ensuring 95% penetration in them.

In addition, on the basis of the complex reasoning presented in the letter, the rheumatologists request the withdrawal of the CNAS proposals to amend the Government Decree No. 10. 696/2021 for the approval of service packages and the framework contract, as they were published in the transparency of decisions, and in particular Article 156^ 1, and support a number of alternative proposals:

• 1. preservation of the obligation to obtain the informed consent of the patient for all types of biological therapy, both biosimilar and original;

• 2. implementation of other agreed measures to save the budget, without affecting the rights of patients and medical practice:
• a) cancellation of the application of the provisions of CNAS order no. 615/2010 (calculation of 120% of the reference price), for biological preparations (both original and biosimilar);
• b) the implementation of a multi-year program to gradually increase the penetration of biosimilars into the market of biologics, associated with a consistent reduction of the amounts paid by CNAS for them through negotiations on significant price reductions.

The open letter, signed by 216 rheumatologists, was submitted to the National Health Insurance Fund, the Ministry of Health, the Romanian College of Doctors, the Presidential Administration, two health commissions of the Romanian Parliament, two human rights commissions of the Romanian Parliament. and Lawyer to people.

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