Bulgarian Livestock Vaccinated against Bluetongue with Product without License

The Sopharma provider is not entitled to trade, store and transport veterinary medicinal products

On December 8, 2014, the Executive Director of the Bulgarian Food Safety Agency (BFSA) issued a decision to launch a negotiation procedure without notice with subject “Supply of Inactivated Monovalent Vaccine Serotype-4 against Bluetongue Disease of Ruminant Animals”. Five companies were invited; only one of them was a manufacturer whose vaccine is authorized for use with the order of the Executive Director of BFSA from November 11, 2014, when a notification was accordingly sent to the European Commission (EC) that this product fits the approved vaccination plan. Huvepharma JSC and ASCLEPIUS-PHARMA LTD were allowed to participate by the opening of the price bids. The first company was admitted to the final stage of the procedure, although it failed to cover one of the minimum technical requirements, namely having a valid license to use the product in a Member State of the European Union (EU), on the basis of which an authorization for use in Republic of Bulgaria was to be issued. BFSA failed to reach agreement with either of the two companies and the procedure was terminated.

The BFSA Executive Director, through statements in various media, is pointing out as a motive the fact that no agreement has been reached with ASCLEPIUS-PHARMA LTD as the company is unable to deliver the vaccine by March 10, 2015. The protocol for negotiation between ASCLEPIUS-PHARMA LTD and BFSA, which is part of the documentation from the public tender, shows that the ability of the company to deliver the product by that date was not at all discussed. Prompted by the statements of the Executive Director of BFSA, on February 9, 2015, the company lodged a letter informing Professor Plamen Mollov that his statements do not correspond to the truth and the manufacturer has 6,000,000 doses (if needed 4.3 million) and needs no longer than four weeks to print stickers, brochures, packages in Bulgarian; to package and deliver the vaccine.

A new public tender procedure was opened on February 16, 2015. Only one company – Sopharma – was invited. On February 17, 2015, a contract for delivery of the vaccine BTVPUR AlSap 4 of the French manufacturer Merial was sealed. The statutory period for appealing the procedure was ten days, i.e. the contract should not have been signed until February 27, 2015 at the earliest, if no appeal of the procedure had been logged. The Spanish producer CZ Veterinaria S.A. appealed the procedure on February 26, 2015. On February 17, 2015, the Executive Director of BFSA issued an order revoking his own order from November 11, 2014, which authorized the use of the Spanish vaccine on grounds of it having a valid license for use of the vaccine in another Member State. Under administrative law, a body that issued an administrative act cannot cancel it on its own and this should be done by a higher authority. In addition, the change must be explained and the interested party that may appeal this decision must be informed, but this was not done. Furthermore, on February 20, 2015, Professor Plamen Mollov issued a new order, which authorized the use of the French vaccine, but it has no valid license for use. The order has no legal value without a Notification of the EC, which is also missing. There is a letter to the EC, but it does not constitute Notification.

By the date of the opening of the new public tender procedure, namely February 16, 2015, the only vaccine that had a valid license and was authorized for use was BLUEVAC-4 of CZ Veterinaria S.A..

Sopharma does not have a license for wholesale trade of veterinary medicinal products and under the Veterinary Law has no right to trade, store and transport veterinary products. Biofarm Engineering, whose owner is Sopharma, has such license, but this is a separate legal entity and it is not specified in the contract as a subcontractor. The number of doses and the deadline for the delivery are not specified in the contract as well.

On March 4, 2015, the Executive Director of BFSA organized a briefing where he showed the French vaccine and a package leaflet for the use of the product. He also displayed a valid license in an attempt to refute the allegations of ASCLEPIUS-PHARMA LTD that the French vaccine has no valid license, thus it cannot be authorized for use and the order from February 20, 2015, is unlawful. The more observant witnesses of this PR show immediately noticed that the valid license proudly displayed by Professor Mollov

was not for the product BTVPUR AlSap 4, but for another one – BTVPUR AlSap 2-4

which is a combination of serotype-2 and serotype-4 and is only for sheep. The public tender was for a vaccine for sheep and cattle, only against serotype-4, because the use of vaccine against serotypes that are not causing a disease is prohibited. In the package leaflet of BTVPUR AlSap 4, accompanying the product, the manufacturer refers for more information to the electronic register of licensed products under the centralized procedure of the European Medicines Agency – http://www.ema.europa.eu/. A valid license for the use of BTVPUR AlSap 4 does not exist there. In the analytical certificate, accompanying the consignment, it is clearly written that safety tests have not been carried out and that the production date was December 19, 2014.

Some very interesting questions arise here. Can the BFSA Executive Director cancel his own administrative act, without giving reasons and without notifying the interested party – holder of a certain right? Can a contract be signed before the expiry of the statutory period of ten days? Can a contract be signed prior to the Commission for Protection of Competition and the Supreme Administrative Courts issuing their rulings if there is an appeal? Can the Executive Director authorize the use of a product that does not have license, moreover only three days after the conclusion of the contract? What is actually being delivered and used on animals in the absence of safety tests? Given that this product has no valid license, i.e. it cannot be used anywhere, was it planned in advance, even before the date of production, to sign a contract precisely for this product?



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