A new procedure for patients with serious illnesses whose treatment is not settled / new changes made by the Ministry of Health

The ministry led by Alexandru Rogobete proposes that the pharma producer or distributor will be fully supported, in the first year, the value of the drugs for patients with serious conditions whose treatment is not settled by the Romanian state. Starting in the second year, “if an additional therapeutic benefit” is found, the cost of the treatment will be supported by 30% by the health insurance house and 70% by the pharma company.

The Ministry of Health has published in decision-making transparency, on Thursday afternoon, a new legislative proposal targeting patients with serious conditions whose treatment is not settled by the Romanian state. The new proposal replaces the one published on Wednesday night and in which the Ministry of Health gave up on Thursday morning, after aroused the anger of patient associations.

The initial ordinance draft provided that patients with serious diseases who do not have access to settled treatment no longer have the right to address justice, by presidential ordinance, in order to shorten the compensated treatment.

Patients without settled treatment, between the court and the goodwill of the Farm company

The new variant of the order of ordinance published by the Ministry of Health leaves to patients who do not benefit from settled treatment the possibility of addressing the court, by presidential ordinance, to obtain access to settlement drugs, if the pharma manufacturer will not be willing to bear the value of the treatment, as the new mechanism proposes.

“These presidential ordinances are used by patients to obtain free treatments when the Romanian state” forgets “to compensate for serious diseases,” says Rozalina Lăpădatu, vice -president of chronic patients in Romania and the president of the Association of Patients with Autoimmune Diseases.

Through this procedure, “the court obliges the National Health Insurance House to settle the treatment of the patient until the trial is judged, which can last a few years,” Rosalina Lăpădatu explained on Wednesday in a Facebook page, shortly after the Ministry of Health had published the initial project in transparency.

“This is how the lives of many people who had immediate access to an absolutely necessary treatment and not after 3 years of processes were saved,” wrote Rozalina Lăpădatu.

What provides for the new legislative proposal published by the Ministry of Health:

• “Art. 7031 – (1) The mechanism by which the controlled access of the patients to the recommended drugs is ensured that do not meet the conditions stipulated in art. efficacy, sustainability and shared responsibility.
• (2) The value of the treatment with the drugs provided in par. (1) shall be supported by the holder of the marketing authorization or, as the case may be, the prescriber doctor having the obligation to monitor the patient, to evaluate the therapeutic benefit and the quarterly reporting of this result. In the event of obtaining an additional therapeutic benefit, after the first annual evaluation, based on an agreement to share the costs concluded between CNAS and the authorization holder for placing the drug or, as the case may be, from the budget of the unique national health insurance fund, 30% of the value of the drug will be settled. The difference of 70% of the costs will continue to be borne by the owner of the marketing authorization or, as the case may be, by the manufacturer.
• (3) Ensuring access to the treatment with the drugs provided in par. (1) is carried out in compliance with the obligation of public service provided in art. 804. ”

Monica Althamer: “Between the European approval of a drug and its compensation, on average, 887 days”

Monica Althamer, patient navigator and the director of the program “Public money hospitals” of the Metropolis Foundation, wrote on Wednesday night, in a post on his Facebook page, that “the Ministry of Health not only is we constantly delaying access to vital treatments. Now he wants to cut us the right to fight for them.”

“For years, patients with serious illnesses in Romania have not received some vital treatments in time. Not because there are no new, innovative therapies, to help them in the fight for life, but because in Romania, between the European approval of a drug and its compensation, on average, 29 months. 887 days! 481, Bulgaria – 702 days.

“Is this the state saves? Stop the thefts, fly incompetents and thieves from those chairs in which you sleep! Stop paying Hospital managers with 2 employees to clean the country's largest hospitals, on hundreds of thousands of euros annually! Do not save people!”