State Refused to Release Information about Vaccine against Bluetongue Disease

The Bulgarian Food Safety Agency (BFSA) and its Director did not announce the name and license

The Spanish company CZ Veterinaria is trying to stop the procedure for the delivery of vaccine against Bluetongue, serotype 4, by filing a complaint with the Commission for Protection of Competition (CPC). The Spaniards lodged their claim against the decision of BFSA to assign the supply of vaccines to the French Merial. This puts once again Bulgarian livestock at risk.

Another episode of the drama with the supply of vaccine against Bluetongue started on February 18, this year, right on the day of BFSA’s anniversary. Then, its Chief Executive, Prof. Plamen Mollov announced that it has signed a contract for the supply of immunological veterinary product for vaccination against Bluetongue, serotype 4. Mollov mystifyingly informed that the product is produced in France, without communicating its name. The supplier of the product was not announced either. Damyan Iliev, Deputy Director of the Food Safety Agency, stated later that the company is the manufacturer Merial. It is part of the pharmaceutical corporation Sanofi-Aventis. And Iliev, like Mollov, stubbornly refused to name the French medicine that will save Bulgarian livestock from Bluetongue. The supplier also remains anonymous. Rumors emerged that this company is associated with Bulgarian businessman Ognyan Donev, the owner of Sofarma.

Corruption is worse than disease

There are many uncertainties around the vaccine. As a reference, the manufacturer Merial has a vaccine against Bluetongue with a central European license. That, however, is a bivalent vaccine – against two Bluetongue serotypes simultaneously – respectively 2 and 4. It is applicable only for sheep. According to European regulations, this vaccine is not applicable in Bulgaria because only serotype 4 is established in the country. The European Commission prohibits vaccinations against serotypes that are not causing disease in a particular Member State. Moreover, cattle will be also vaccinated in Bulgaria. The official representative of Merial for Bulgaria – SAM BS LTD has not submitted documents for participation in the announced on December 8, 2014, public tender for the supply of the vaccine. The company representative even launched an appeal procedure in the tender announced by BFSA. Their action was motivated with the requirement that the vaccine should be applicable to sheep and cattle being an insurmountable one for the vaccine Merial. Moreover, SAM BS LTD complained that the criteria of the tender procedure could be fulfilled by a single supplier – Asclepius PHARMA LTD, representative of the Spanish CZ Veterinaria. As Bivol already wrote, this laboratory is the only manufacturer in the EU of the inactivated monovalent vaccine against Bluetongue serotype type 4 – BLUEVAC-4, which has a license for the use of the product in the territory of the Union.

With its decision number 72 28 01 2015, CPC dismissed SAM BS’ LTD claim. The Commission for Protection of Competition referred to the fact that the criteria for selection of vaccine must comply with common European requirements, implemented in local law. Currently, they are fulfilled only by the product BLUEVAC-4. Moreover, to meet the requirements of the EC, Plamen Mollov sent on November 11, 2014, a notification to the Directorate General SANCO (Directorate General for Health and Food Safety of the European Commission) that the use of the immunological veterinary medicinal product BLUEVAC- 4 will be aligned with the approved by the Commission vaccination plan. “This vaccination plan is an integral part of the” Program for Surveillance of the Disease Bluetongue of Ruminant Animals in Bulgaria in 2014-2015 “, approved by the Commission. In practice Mollov declared to the EC that BLUEVAC-4 will be used in Bulgaria.

After the CPC decision, the procedure continued, and the price offers of two companies admitted to this final stage of the procedure were opened on January 30. Huvepharma of businessman Kiril Domuschiev and Asclepius PHARMA LTD. Allowing Huvepharma to be finalist is problematic, because they have not presented a license for the use of the vaccine they offered to deliver. They also had problems with their documentation. They wanted the vaccine to be accompanied by a provisional (quarantine) certificate. In practice this means that the vaccine certificates were to be presented after it is injected in cattle. And what would happen if it ends up being ineffective?

The Tender Committee rejected the proposal on the ground that the law explicitly precludes such an option. When Asclepius PHARMA LTD remained the only possible provider, BFSA offered to prepay 30% of the vaccines. The remaining 70% or over 3.2 million levs had to be paid 30 days after delivery – when vaccines have already been used. The supplier agreed with the payment scheme, but wanted a State guarantee for the payment of the 3.2 million levs. BFSA refused then to provide such a guarantee. As of January 30, when the parties negotiated, there was no secured financing of the delivery. Only on February 4, at the regular meeting of the Council of Ministers, a decision to provide 4.625 million levs from the budget of the Ministry of Agriculture was adopted. The State Gazette published in its issue 13, decree 26 from February 10, 2015, approving the additional cost of purchasing Bluetongue vaccine.


Има ли лиценз ваксината  срещу Син език?

History of bureaucratic machinations

In reality, the money for vaccines became available only after February 17. At that time, however, the procedure for delivery of the immunological product was discontinued. This happened with order RD11-190 from February 2, 2015, of the Deputy Executive Director of BFSA, Tencho Tenev, on the ground that “all bids failed to meet the criteria predefined by the contracting authority”. Prof. Mollov publicly announced during a briefing in BFSA that the reason for the termination was the inability of the two companies to deliver the vaccine by March 10, 2015 – the set deadline for the delivery procedure. On February 9, 2015, Dr. Georgi Yanchev, manager of Asclepius PHARMA, notified BFSA that the company was able to deliver the vaccine no later than four weeks after the conclusion of the contract and the prepayment, because the manufacturer CZ Veterinaria had the product in stock. At that time, the Spanish laboratory had six million doses – packed and accompanied by analytical certificates for the lot, in accordance with the law. If the texts were to remain in Spanish, the supply period would be shortened by 10 days, due to the urgency of vaccination, Yanchev reported. Fortunately for Ascleipus PHARMA, CZ Veterinaria had millions of doses because Romania, Croatia, Hungary, Spain and Portugal also ordered its vaccine serotype 4, as the only one possible to be used in the EU.

Bluetongue is treated “in the dark”

On February 17, on the political talk show “More from Today” of the Bulgarian public television BNT1, with host Dimitar Tsonev, the Executive Director of the Food Safety Agency announced that there was already a contract for the supply of the vaccine against Bluetongue. On the next day, at 11:00 am, during a briefing in BFSA, Mollov reported that the vaccine was French. It has already been manufactured, packaged, labeled and would travel from France to Bulgaria on February 27, 2015. The State official, however, declined to disclose the name of the vaccine before March 4 and argued that there was a license for its use, but refused to show it.

The document is public and is by far overdue to be uploaded on the BFSA site. The approved by the EC program to combat Bluetongue with which the Commission agreed to co-finance 50% of the vaccination is also missing on this same site. Such a program has not been provided to farmers’ organizations either, though they had written to BFSA and the Ministry of Agriculture, asking for it. The question which company would produce vaccine without knowing if there will be a market and realization remains open. The process of manufacturing of such veterinary medicinal product (VMP), according to BFSA, requires at least four months or 120 days. When was Merial notified that they were chosen to produce the vaccine for Bulgaria? There were less than 15 hours between Mollov’s announcement that the contract has been signed and the briefing during which he reported that the vaccine was manufactured. When did the French master the space-time continuum and how did they manage to do in 15 hours something for which other manufacturers need at least 120 days? Is Professor Mollov connected to this revolutionary discovery? Because the name of the product has not been disclosed yet, we will call it the “secret French miracle”.

It is still unclear how the “secret French miracle” is labeled, because according to the law, the draft texts in Bulgarian shall be based on the approved summary of product characteristics, which is an integral part of the license for the use of the medicinal product.

However, the “secret French miracle” does not exist in the BFSA’s registries of licensed and authorized VMP. In addition, we cannot find any other vaccine serotype 4 manufactured by Merial. We did not find a license issued by February 21, 2015, for the use of such a vaccine produced by Merial in the registries of any of the Member States in the EU and in the Central Registry of the European Medicines Agency. Executive Director Mollov ordered veterinarians to start the vaccination with the “secret French miracle” with order of RD11-292 from February 17, 2015. The order should be applied from March 1, 2015. In the attached standard operating procedure for vaccination, the Executive Director continues to keep secret the name of the vaccine to be administered. With this order Mollov involves veterinarians in a breach of the law, because article 276 of the Veterinary Activity Law is firm that only VMP licensed for use can be applied in the country and so far the “secret French miracle” does not fall into this category. Separately, it is not clear if the “secret French miracle” will require revaccination. Mollov ordered such to veterinarians, but insists before the media that the livestock will be vaccinated once, which will save money.

Clearly, the Bulgarian livestock can become again a victim of corruption and bureaucracy. The prosecution will not react to white-collar irresponsibility as it failed to do so in all epidemics that ruined the livestock industry in recent years. Because of the “dark” procedures, Bivol advises all farmers to implement the old recipe for the treatment of Bluetongue from the Strandza Mountain. Animals are closed in a completely dark barn or pen and are held there for three days. Then they get better. Maybe this will help.



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