Parallel imports in Bulgaria are lagging behind regulatory obstacles
The shortage of medicines in Bulgaria is due to the lack of import and withdrawal of medicines from the Bulgarian market

In Capital Health, 23rd November 2018


Shortage of medicines is a global problem and a hot topic in the European Union. Its causes are multifactorial and exports are not among the leading ones. We have repeatedly cited global and European reports that are clear that production problems and regulations take a major lead. Evidence that parallel distribution does not generate any gaps is a shortage in countries like the United States or Serbia, where parallel trade is not taking place.

As a publicly committed NGO this year BAMPTD's priority was to seek an effective solution to the issues of access to medicines. The Association launched a cooperation program with patients, which was written in a Memorandum of Cooperation. Federation of Bulgarian Patients' Forum and BAMPTD have declared that they are joining their actions in the name of guaranteed access of Bulgarian patients to therapy and achieving an effective regulatory framework that not only establishes restrictions but creates opportunities for businesses to provide the necessary medicines on time.

BAMPTD built the first online drug-shortage warning platform in Bulgaria that has been in operation for 6 months. This is how we contribute to the priorities of the EMA Task Force on "Improving the availability of medicines in the EU". Our contribution is to facilitate communication on issues related to drug delivery to citizens, to promote stakeholder cooperation and to provide the public with clear and useful information on drug availability issues and supply disruptions across the EU.

53% of the shortage of medicines in Bulgaria is due to a lack of imports

The interim results of our national online survey have shown that in 53% of the cases, the solution lies in imports and rapid intra-community supplies. Patient alerts refer to deregistered drugs, products with permanent or temporary discontinued imports into Bulgaria. Another main conclusion is that the lack of information accounts for 65% of the signals. 20% are closed cases with information provided where the medicine is available, and over 60% of the senders are directed to their caregiver. 

BAMPTD online platform for signaling drug shortages in figures:

- 53% of the shortage signals would be solved by imports

- 65% of alerts are due to lack of or poor information

- 42% of the signals come from Sofia, over 80% of the big cities

- 20% are the people directed to a pharmacy nearby to get their medicine

- 66% are referred to their treating physicians for amending the treatment regime due to lack of imports, products not registered in our country or when searching for hospital products pharmacies

- The average feedback time is 12 hours

- Alerts solution average time is up to 32 hours

Feedback time for addressees is up to 12 hours, and up to 32 hours is for solution of the signal, which is highly rated by the respondents. For each product found, written or telephone feedback was obtained to successfully supply the patient with the necessary medication. The platform continues to receive and service deficiency signals.

The main reasons for reporting a shortage:

- 51 products are reported because they are not found in the first pharmacy in the settlement, while it is available in other pharmacies in the city

- 50 products have suspended imports or discontinued sales on the Bulgarian market

- 29 drugs have no registration in Bulgaria

- 9 are hospital products that are not available in an open pharmacy

- 8 products are temporarily suspended

No prohibitions and discriminatory measures but imports encouraging will overcome the deficit of drugs

The conclusion that imports and more information are needed confirms our task of conducting an active dialogue to achieve an adequate and non-discriminatory regulatory framework that ensures the availability of medicines in our country. We know that only such legal and regulatory infrastructure would largely solve the drug shortages in Bulgaria and will ensure that patients in Bulgaria have access to the variety of medicines in all European countries and not only those registered with local market.

Urgent amendments to the Ordinance on Regulation and Registration of Prices for Medicinal Products are needed. Since 2014, this sub-legal act has established a restrictive restrictive regime that hampers parallel imports at competitive prices and restricts patients' access to medicines. The requirement to re-refer to the price of medicines from parallel imports is virtually neglected and makes it impossible for new medicines to be made in the last four years. This is the reason for a total of 128 parallel drug admissions, only 75 of which are marketed in Bulgaria. Among them are medicines for diabetes, hypertension, pain syndrome, which patients pay 100% and are not subject to reimbursement. This reduces their cost even more for patients. Their value after the introduction of drugs from parallel imports actually decreased by between 20 and 40%.

Dropping the second reference of parallel imports and rapid intra-community supplies - strong levers to prevent the shortage of drugs

Our insistence is with amendments to the Ordinance on the prices of medicinal products, to introduce a regulation whereby the parallel imported product should benefit from the registration already made by the first sponsor. Parallel import of medicinal products must receive the price of a medicinal product already in the drug price registry.

The changes we have been asked for years in LMPHM are in several ways. The main suggestion of BAMPTD, which is extremely important for patients, is to allow parallel imports of medicines that have been deleted in Bulgaria for non-pharmacological reasons. It is because of them that many Bulgarian patients have become traveling buyers of medicines from neighboring and not so close countries.

There are a number of examples of rapid import and adequate intervention by parallel distributors in Europe. In Bulgaria there has been since the summer of last year when for several months a lack of a medicine for cardiovascular diseases occurred and the producer declared that it could not provide quantities for the Bulgarian market. Two parallel distributors secured supplies for the entire summer, and patients did not feel deficient and did not have to go through a change in their therapies. The case here is that both parallel co-importers at the time had current authorizations to use for parallel imports. Our aim is not to rely on random coincidences, but to have a regulatory procedure for quick import in the event of a crisis situation.

BAMPTD declares its commitment to continue to be a strategic and trustworthy partner of the institutions and to work to protect the public interest. Parallel distributors have the capacity and expertise to make solutions in the event of a shortage and to prevent it. Understanding and promoting parallel distribution at national level will continue to be our main task and we believe that we will achieve constructive solutions together with the institutions in the name of Bulgarian patients.

Boryana Marinkova

CEO of BAMPTD

Boryana Marinkova is responsible for fulfilling the BAMPTD goals of ensuring the access of Bulgarian patients with quality and effective medicinal products under competitive conditions and initiating changes for rapid parallel import of shortage drugs. She has 11 years of experience as marketing director at Tokuda Hospital since the opening of the biggest private hospital in Bulgaria. Between 2012 and 2017 he heads the public relations of the National Association of Private Hospitals. She graduated in Marketing at the University of National and World Economy in 2004. She has two certification programs at BEIED - Professional Marketing Management and Professional Executive Management in 2015. Currently she is a PhD student in Public Administration.

Dowload the full article in Bulgarian
Download the EN translation