Does the law say anything about the transportation of vaccines by sausage bus?

The transport of the first vaccines in Bulgaria against COVID-19 in the country in minibuses of a famous sausage company caused a wave of comments, ridicule and criticism on social media. But in addition to all this, questions are accumulating about how legal this is and if it managed to prepare and organize the so-called Vaccination Site.

And does the state, which strictly monitors how drug traffickers store, transport and monitor products, turn a blind eye to regulations when its structures are engaged in the same activity?

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This is what is written in the Law of Medicines in Human Medicine that, among other things, defines the wholesale and retail trade of medicines:

“Art. 1977. The persons referred to in art. 195 (Editor’s note – Persons approved by the regulator for wholesale trade) should have with:

1. adequate premises, equipment and facilities and suitable means of transportguarantee the adequate storage, distribution and transport of medicines in accordance with the requirements of Good Distribution Practices “

Article 198 of the same law establishes that the principles and requirements of Good Distribution Practices are established in an ordinance of the Ministry of Health. But, in fact, there is a special European Union Guide for this practice.

The Bulgarian ordinance states that distributors are obliged to:

“10. provide the necessary conditions for transport of drugs that require special storage conditions (temperature, relative humidity, direct sunlight, etc.) “

The European manual is much more detailed: it describes the requirements for a control system, as well as the rules for working with an external contractor:

“The quality management system must cover the organizational structure, procedures, processes and resources, as well as the activities necessary to ensure that the quality and integrity of the delivered product is maintained and that it remains within the legal supply chain during storage. and / or transport. (…)

Distributor management must ensure that all elements of the quality system are adequately assured by competent personnel and Adequate and sufficient premises, equipment and facilities. (…)

You need a shift control system that works. This system should include risk management principlesrelated to quality “.

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We assume that the vaccine distributor currently does not have vehicles and apparently outsources this activity, which is also outside the drug supply system.

There are also special texts in the European Guide for this case:

“The quality system must include the control and inspection of all activities outsourced and related to the acquisition, possession, supply or export of medicines. These processes should include quality risk management and cover:

me) assessment of the suitability and professional training of the contractor in relation to the implementation of the activity and verification of the status of the permit, if required “.

If something happens to vaccines on the way, the responsibility, at least according to European guidelines, does not lie with the carrier:

“Wholesale distributor assume the responsibility to protect medicines against breakage, counterfeiting and theft, as well as to ensure the maintenance of temperature conditions during transport within acceptable limits.

Regardless of the mode of transport, it must be possible to demonstrate that medicinal products are not exposed to conditions that could impair their quality and integrity. A risk-based approach should be used when planning transportation. “

as much as:

“The wholesale distributor must guarantee that the vehicles and equipment used for the transport, storage or handling of medicines, are suitable for use and are equipped accordinglyto prevent products from being exposed to conditions that could affect their quality and the integrity of the packaging. “

and

“When handling medications, if possible, specialized vehicles and equipment should be used. When specialized vehicles and equipment are not used, procedures should be established to ensure that the quality of the medicine is not compromised. “

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Television reports on the arrival of the shipment in Burgas showed that the packages were opened and shown to cameras, after which they were returned to a refrigerated display case. The vaccine instructions for personnel in the United States, for example, state: “Reduce exposure to light in the room during storage and avoid exposure to direct sunlight and ultraviolet.” Placing the vaccines in a refrigerator with a glass door through which light penetrates suggests that in a room with windows it is expected that the product will be protected only by the cardboard box containing the vials.

From the moment of turning off the GPS device from the box delivered by a Polish carrier, Phizer is not responsible for the vaccine, this becomes an obligation of the Bulgarian state. According to the Minister of Health, there is no problem with the use of minibuses for sausages, and the proposal for them came from the Association of International Transporters because they had adequate refrigerated trucks.

C in art. 13 of the Law of Measures and Actions during the State of Emergency, the administration is exempt from compliance with the Public Procurement Law and can assign it directly at its discretion when it comes to anti-epidemic measures.

The position of the company

The company “Bella Bulgaria” sent a letter to the media explaining the situation with the transport of vaccines. The company owns the buses that distribute sausages, with which the vaccines were delivered to Plovdiv and Burgas today.

“In response to a request from Bull Bio, Bella Bulgaria offers free specialized refrigerated transportation of COVID-19 vaccines, destined for our country,” the company said. They add that their fleet meets the most modern European requirements for this type of vehicle. “They are equipped with the most modern refrigeration equipment, supporting special temperature regimes, sensors, thermograph, etc. The high quality of the company’s refrigerated transport services is a guarantee of full compliance with the conditions for the rapid and quality transport of the vaccine to points throughout the country ”. , are categorical of “Bella Bulgaria”.

“We believe that in the conditions of unprecedented crisis that we are going through, we all have the obligation to contribute to overcoming it, regardless of the particularities of their activities. The situation is complicated. The humor is inappropriate,” the company concluded.