The Bulgarian authorities are accused of aggravating shortages of scarce medicines by imposing administrative obstacles to parallel trade, the Bulgarian Association for the Development of Parallel Trade in Medicines (BADPTM) has claimed.
Parallel trade in medicines is allowed and encouraged in the EU. The EU pharmaceutical market allows for the resale of drugs in any EU/EEA country without the authorisation of the owner of the intellectual property (IP) rights associated with those products.
It’s a response to price discrimination, whereby an identical product is sold at different prices in different countries, and occurs under strictly regulated conditions – medicines are moved to the destination market and repackaged to comply with national legislation and linguistic needs.
“Artificial barriers to the parallel distribution of drugs hinder patients’ access to therapy and harm the competitive market in the country,” Boryana Marinkova, the executive director of BADPTM, told EURACTIV.
In Bulgaria, 324 drugs are supplied through parallel imports by four large companies, yet the association complains that the release of some medications for sale in pharmacies is sometimes delayed for more than a year, because the authorities are unable to set prices.
The pattern of delays is varied – it took 416 days to register a price for Moduxin, which is used by patients with coronary disease; a delay of 169 days to determine the price of the macrolide antibiotic Sumamed; 106 days to determine the price of a Ventolin inhaler; 93 days for the diabetes drug Glucophage, and there is a delay of over two months for many commonly used antibiotics and insulins.
Medicines in pharmacies but out of reach
One of the problems is that Bulgarian legislation does not allow pharmacies to sell drugs from parallel imports to patients whose therapy is paid for by the state. A medicine may be available at the pharmacy but cannot reach the patient due to bureaucratic obstacles – drugs from parallel and direct imports receive different registration numbers.
According to Marinkova, the state puts patients in the absurd situation of not receiving the necessary drugs, even though they are available in the pharmacy network. Many people with diabetes are sometimes forced to buy their medication, even though it is legally provided free of charge. The other big problem is the slow release of prices of drugs from parallel imports.
Delays in setting prices
“We are perplexed by the fact that the National Council on Prices and Reimbursement of Medicinal Products needs hundreds of days to register an already existing price of drugs for diabetes, cancer [and] hypertension. When there is a price for the equivalent product, it can be entered immediately, and the medicines can reach the patients quickly,” Marinkova commented.
She added that in the EU, parallel distribution actually solves the problems of drug shortages. According to her, the contribution of parallel imports during the COVID-19 pandemic in the supply of antimicrobial drugs is indisputable in order to avoid acute shortages.
“Artificial barriers to parallel distribution hinder patient access to therapy and harm our state’s competitive environment,” she added. According to data from Affordable Medicines Europe (AME), which represents parallel drug traders in Europe, in 2022, working parallel imports led to savings of €202m, €60m, €31m, and €67m per year for Germany, Sweden, Denmark and Poland respectively.
Obstacles associated with parallel trade
Bulgaria imports the most drugs from Romania through parallel trade and exports the most to Poland. In response to a question about how the new EU pharmaceutical legislation will contribute to better access to drugs at affordable prices for patients and national health systems, Marinkova said it was too early to give an assessment because the negotiations were at an early stage. The Bulgarian Ministry of Health has not yet commented on the association’s accusations.
While the Bulgarian authorities are accused of placing artificial obstacles to the sale of drugs from parallel imports, problems periodically arise in Bulgaria, which MPs and patients associate with parallel exports. In November 2023, nearly 200 Bulgarians with diabetes wrote an open letter to the national ombudsman and the parliament about the lack of vital medicines.
The ordered inspection showed that medicines for people with diabetes in Bulgaria are imported rhythmically and are available in the medicine warehouses, but in practice, they do not reach the pharmacies en masse, and the patients cannot get them. Then, the Deputy Minister of Health Ilko Getov directly admitted that one of the diabetes drugs was kept in warehouses to be exported afterwards.
This case, from November last year, showed that domestic mechanisms to stop the export of scarce drugs are not working effectively. The complaints of the parallel trade association show that excessive bureaucracy prevents Bulgaria from also benefiting from the advantages of parallel trade.
[By Krassen Nikolov, Antonia Kotseva, Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]
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