People with rare and life-threatening diseases, including many children, may find themselves facing delays in their necessary treatment due to proposed changes in the procedure for providing unregistered medicines.
The Association of Importers of Unregistered Medicinal Products for the Treatment of Rare Diseases warns about this in a public declaration to institutions.
The organization opposes the proposals for changes to Art. 266a of the Act on Medicinal Products in Human Medicine, according to which medicines without a marketing authorization in Bulgaria will henceforth be provided mainly through centralized supplies or procedures under the Public Procurement Act.
When there is no alternative, time is of the essence
According to the Association, the current mechanism allows for the rapid provision of therapy for a specific patient when there is no other treatment option. The medicine is prescribed by a medical commission, delivered to the specific person and paid for by the state when there is no registered alternative.
The organization points out that this order is not an exception created only at the national level, but is a mechanism also provided for in European legislation, specifically for cases where the patient does not have access to other treatment.
The new procedures will not create competition
According to the submitters of the declaration, turning public procurement procedures into the main mechanism will lead to additional administrative burden and delay.
“Where the medicine has one manufacturer, competition cannot be created by law“, the Association points out. According to them, a large part of these products are intended for a small number of patients, often have one manufacturer or one official representative for Europe, and the need for them arises individually – after a specific diagnosis is made.
Concerns about treatment delays
According to the organization, advance planning of supplies at the national level is difficult to implement, as the need for the drug cannot be predicted with certainty. Each patient has a different therapy, dose and time of need.
The association warns that the new requirements may lead to the interruption of already started treatments and place medical institutions in a situation of legal uncertainty due to complex administrative procedures.
“In progressive and life-threatening diseases, lost time is not returned“, the organization states.
Transparency through accountability, not through additional procedures
They emphasize that they support full transparency in the spending of public funds, but believe that it must be achieved through the publicity of information, accountability and control, and not by introducing additional procedures between the patient and his necessary treatment.
The declaration also states that the Commission for the Protection of Competition has recommended measures for more transparency – a single public list, publicity of invitations and contracts and better accountability, instead of centralized tenders for supplies intended for specific patients.
Insisting on dialogue before changes
The organization insists that the proposed changes be withdrawn or rejected by the National Assembly, and that any future change in the system be discussed with patient organizations, medical specialists and medical institutions.
“Behind each of these supplies stands a name, a diagnosis and a family that is counting the days“, the Association concludes and calls for access to treatment to remain the guiding principle in decision-making.
You can read the full text of the declaration – HERE.
Source: kmeta.bg