PM Dancila uses wrong term when referring to ‘immunoglobin’ crisis –soon to be solved. Drug supplier claims it could provide 10,000 vials


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Prime Minister Viorica Dăncilă has said on Wednesday, at the Government sitting, that the immunoglobulin crisis will be solved soon by triggering the European Civil Protection Mechanism. The Prime Minister has misused the term six times, pronouncing ‘immunoglobin’ instead of ‘immunoglobulin’, media report.

“Another issue I want to talk about is the triggering of the European Civil Protection Mechanism and I refer to immunoglobulin. In the past days, I have given the approval to Health Minister, Sorina Pintea, for triggering the European Civil Protection Mechanism due to the lack of immunoglobulin in hospitals. The impact on the lives of patients diagnosed with primary immunodeficiency, autoimmune diseases, neurological diseases would be very high. Thus, the situation in the past year, in which there was an acute shortage of immunoglobulin, will be finally brought to an end. I think we can solve it over the short term,” Premier Viorica Dăncilă said.

Dăncilă also said that the steps for the purchase of “immunoglobin” will be made by Unifarm National Company, which will also cover the related costs.

“I recall that the discontinuities in the supply of immunoglobulin are generated by the withdrawal of the manufacturers from the market, which supplied 80% of the market, and despite the efforts made by the Ministry of Health in 2017, including the elimination of the clawback tax, the immunoglobulin crisis has continued,” the Premier added.

Health Minister, Sorina Pintea, announced Monday evening that Romania has triggered the civil protection mechanism for immunoglobulin, as the medicine lacks from the domestic market.

“The reason is obvious, i.e. the lack of immunoglobulin from the domestic market, the medicine is not available for the patients. We’ve made efforts, the Government has suspended the clowback tax and nothing happened. In March there is no chance to have any vial with this drug. We have promises for April. We’ve received the go-ahead from the Premier to activate the procedure. It is about the alert at European level, we request immunoglobulin at European level,” Sorina Pintea said for Antena 3 TV private broadcaster.

Drug supplier says it notified the Health Ministry it can supply 10,000 vials, no answer received

Torus Pharma Medical Distributor claims it has notified two months ago the Ministry of Health that it can bring to Romania at least 10,000 immunoglobulin vials, but the competent authority has not officially responded, the company informs.

Torus Pharma, representative of Reliance Lifescience, a manufacturer of plasma and blood products, sent the Health Ministry last year information on its availability to meet the immunoglobulin requirement in Romania by delivering human immunoglobulin for intravascular administration, but so far has not received an official response from the institution.imnoglobulina

“Until today, the Ministry of Health, through the National Medicines Agency, hasn’t provided an official response, but we were contacted by telephone, in early February, by representatives of the Ministry, responsible for the drug policy, and during the telephone conversation we have confirmed the possibility to supply this drug on the market in Romania, after obtaining the marketing authorization, at the price of the other manufacturers,” Dr. Isabela Komporaly, director of Torus Pharma, said.

Immunoglobulin produced by Reliance Lifescience is not registered in Romania, and the registration process has been initiated on December 28, 2017. The dossier was reviewed by two specialized committees (Paediatrics and Infectious Diseases) with the Ministry of Health, which have issued favourable responses to support the authorization of this medicine.

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