The MoH purchased COVID-19 medication from China without the required documentation and sold it as a general treatment in violation of the law

ACF has alerted the Prosecutor’s Office about an irregular purchase order of medicines from China and their subsequent distribution to medical institutions in the country in violation of the law.

At an emergency session held on 3 April 2020, the Bulgarian Government approved two draft contracts with the Chinese National Pharmaceutical Foreign Trade Corporation. The first contract was for the supply of 171,429 units of Hydroxychloroquine Sulfate Tablets 100 mg. The other was for the supply of 30,000 units of Azithromycin Dispersible Tablets 250 mg. Both medicines are used to treat COVID-19, and the total value of the two contracts amounted to USD 629,000.

Article 7 of the Medicinal Products in Human Medicine Act (MPHMA) provides that in order for a medicinal product to be allowed for use in Bulgaria, it has to be approved by the Bulgarian Drug Agency (BDA) in accordance with the MPHMA or by the European Medicines Agency in accordance with Regulation (EC) No 726/2004.

However, Art. 10, par. 1 of the MPHMA stipulates that in extreme circumstances (epidemic outbreaks, radiation, chemical threats) and in the absence of an appropriate medicinal product that has already been approved, the minister of health can — in line with a well-reasoned proposal by the country’s chief health inspector and in coordination with the executive director of the Bulgarian Drug Agency — authorize treatment with an unapproved medicinal product for a limited period of time in order to overcome the extraordinary situation.

This was the precise legal procedure invoked for allowing the use of the two Chinese anti-COVID-19 medicines on 5 May 2020. The approval period was fixed to the duration of the emergency epidemic situation.

At the end of May 2020, scientists expressly denied the positive effects of quinine preparations on COVID-19 patients [1]. Some publications even claimed that such preparations had a negative impact on treatment efficacy and death rates [2]. On 4 July 2020, the World Health Organization (WHO) adopted the recommendation of The Solidarity Trial’s International

Steering Committee to discontinue clinical trials with hydroxychloroquine with immediate effect. The reason was that treatment with that drug led to little or no reduction in the death rate of hospitalized COVID-19 patients [3].

In the meantime, in the middle of July 2020, Deputy Health Minister Zheni Nacheva promised the Chairman of the Bulgarian Organization for Patients with Rheumatic Diseases that part of the Chinese hydroxychloroquine would be given to lupus and rheumatoid arthritis patients free of charge via the hospitals where they receive their treatment. “Such actions are in blatant contravention of the legal procedure for allowing the use of medicinal products. It is precisely the strict observance of the Medicinal Products in Human Medicine Act that guarantees Bulgarian citizens access to safe, quality and effective treatment,” comments Sofia Zheleva of ACF’s legal team and adds, “In accordance with the CoM resolution of 3 April 2020 and the order of Minister Ananiev dated 14 May 2020, the hydroxychloroquine that the MoH will readily give to lupus and rheumatoid arthritis patients is purchased and allowed for use only for the purposes of treating COVID-19. The use of the two Chinese medicines in any other treatment is in serious violation of the law and endangers the patients concerned.”

In accordance with 3 letters issued on 25 June 2020 and 17 July 2020 by Minister Ananiev and Deputy Minister Nacheva, all the purchased Hydroxychloroquine Sulfate and Azithromycin units were distributed among the regional health inspectorates (RHI) in the country to be used for treatment of COVID-19, lupus, rheumatoid arthritis, and for general antibiotic treatment (only Azithromycin). All RHI in the country confirmed to ACF that they had received the medicines and sent them to the medical institutions within their respective areas.

According to the ACF team, the letters sent by Deputy Minister Nacheva and Minister Ananiev to all RHI directors in the country, with which they authorized the use of the two Chinese medicines for treatment of lupus and rheumatoid arthritis patients, are not only in violation of the law, but also endanger the health of the Bulgarian citizens who end up taking the medicines.

ACF has submitted detailed questions to the competent institutions — the CoM, the MoH, and the BDA, among others — about the negotiated contracts and the subsequent actions surrounding the inspection and distribution of the drugs. It took more than 6 months and one court trial to receive responses to the posed questions.

By analyzing the information obtained from the institutions, as well as other publicly available facts, we established the following:

– On 15 May 2020, 171,429 Hydroxychloroquine Sulphate tablet 100mg x 14 and 30,000 Azithromycin Dispersible tablet 250mg х 12 were supplied and handed over for safekeeping to Bul Bio – NCIPD EOOD.

– Only 12 out of more than 200,000 total units of the two medicines were sent to the BDA for examination.

– During an open hearing at the Sofia-City Administrative Court, the BDA expressly stated that the 12 units were sent to them without any accompanying documentation; all they received were the drug boxes containing the blister packs inside.

– The letters issued by Nacheva and Ananiev permitted and advised the use of the two medicines for treatment of COVID-19, lupus (only Hydroxychloroquine), rheumatoid arthritis, and for general antibiotic treatment (only Azithromycin), in violation of the law.

– Permitting the use of the medicines for general treatment is not only in absolute violation of the law, but also endangers the health of the patients receiving them. The medicines were produced by unknown manufacturers with no company website and no publicly available information about them; the medicines entered the country without any accompanying documentation or information about their specifications and properties. Essentially, they were given to patients on the basis of a chemical analysis of 12 out of 200,000 units.

– The use of the Chinese anti-COVID-19 medicines also infringed the rights of Bulgarian citizens and posed threats to their lives and health. This is due to the fact that all of the 171,000 units of Hydroxychloroquine and 30,000 units of Azithromycin were distributed by the MoH for treatment of COVID-19 patients after the WHO had announced their position (to discontinue the use of hydroxychloroquine for treatment of COVID-19 due to identified negative effects of the drug) and discontinued the use of the drug in a number of countries.

– The are no signed contracts for the purchasing of the medicines and no measures have been taken to protect the rights of the Republic of Bulgaria as a buyer.

“These facts, established with reference to official documentation, raise serious concerns that the authorities did not exercise due care in protecting the health of Bulgarian citizens, considering that the latter were given medicines whose quality has not been duly examined, and in the presence of strong scientific evidence that this type of COVID-19 treatment is not very effective,” states Boyko Stankishev, Director of ACF. “In order to clarify the raised doubts and safeguard the health of Bulgarian citizens, ACF is referring the case to the Prosecutor’s Office, along with all the information we have on our hands,” Stankushev adds. You can access and read our report to the Prosecutor’s Office here.