BAMPTD news

Boryana Marinkova is the CEO of the Bulgarian Association for Medicines Parallel Trade Development (BAMPTD). Marinkova is responsible for the implementation of the BAMPTD goals, which are to ensure the access of Bulgarian patients to quality and effective pharmaceutical products under competitive conditions and to initiate changes for rapid parallel import of medicines. She has   11   years of experience   as a Marketing   director at   the

international healthcare investment Tokuda Hospital since the opening of the largest private hospital in Bulgaria. She was there managing the implementation of the marketing plan, corporate communications and strategic development. In the period 2012-2017 she was responsible for the corporate affairs and the PR of the Bulgarian National Association of Private Hospitals. She has a Master degree in Marketing at the University of National and World Economy in 2004 after a Bachelor's program in Economics at UNWE. She is certificated by BEIED in Professional Marketing Management in 2009 and Professional Executive Management in 2015. Currently she is undergoing a PhD program in Public Administration and a lecturer in Integrated Marketing Communication at the University of National and World Economy.

The Parallel Trade market has matured greatly over recent years, what key differences have you noticed in the last year regarding significant developments? 

“What actually has changed is the perception about parallel distribution and its better understanding. The COVID 19 pandemic showed in practice that parallel trade is important and vital part of the solution in fighting shortages – and definitely that solution proved to be flexible, affordable and safe. Now we know that there is now such phenomenon as unilateral flow and there are no south to north/east to west trends of parallel imports’ flows.

In June 2020 AME published a study that revealed in figures that more than half of the parallel imports in Europe are sourced in high-income countries like Austria, Belgium, Denmark, Finland, Germany, Netherlands, Norway, Spain, and Sweden. The country exporting most medicines per capita is Norway. The average European export per capita was 16.4 euro and a number of countries often considered to be lower-priced exporting countries such as Hungary, Italy, Poland, Spain, Estonia, Croatia, and Portugal export below or far below the European average, the study shows.

That means that distribution among northern, southern and eastern countries is considerably homogeneous and this myth is eradicated.”

What are your thoughts on how COVID-19 is currently impacting the Parallel Trade industry and your role?

“COVID 19 stressed the globe emphasizing the need of fast and flexible solutions in the supply chain of medicines. Parallel distributors managed to play important role in the pandemic in those countries that followed the EC Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak for open borders and no restrictions on export. There are numerous of examples for the input of EU parallel wholesalers. In Bulgaria one of our members managed to supply specific antimicrobials for the COVID 19 protocols but only because the company had prior  permission for imports. We need to learn from the outbreak and to protect the free movement of medicines because solidarity saves lives.”

What current hot topic will you be addressing in your presentation and what would you say makes it relevant to 2021?

“We have created Online platform for missing medicines alert, firstly, to investigate and understand the problems in the supply chain and to help in difficulties in accessing medicines, and secondly, to investigate the causes of the problems and thus offer workable solutions to the competent authorities. We do not claim to be exhaustive because we receive, consider and resolve individual human issues. We study each signal and look for a solution close to the patient when possible, but we investigate them and look for the individual solution.

What are the causes of the signals?

• • 27% are for medicines with temporary difficulties in import mainly due to production reasons
• • 19% of the signals are for drugs, whose import and sales in our country have been

suspended mainly due to economic and marketing reasons.

• • 15% are for unauthorized products in our country
• • 3% are alerts for hospital products that are not dispensed in pharmacies for patients
• • 35% are logistical cases in which we manage to cooperate with the help of wholesalers and

retailers and to find stocks near the patient

What the official statistics for Bulgaria shows: more than 2000 are the deregistered drugs in the period 2014 - 2020 according to BDA. In 2019, at the request of the marketing authorization holders, 287 marketing authorizations for medicinal products were terminated.

We have managed to be useful not only for individual problems. For example, we received a report from your media this year about a missing medicine for breast cancer. It turned out that there were suspended deliveries and inability to import by the marketing authorization holder. The luck in this case was that our member had already issued permit for parallel import, delivered and repackaged stocks. Within 6 days, deliveries were made to the pharmacy network in the country. At present, for example, parallel imports complement the supply of several antimicrobials included in the COVID 19 Protocol.

However, there are also negative examples, I will give only 2: we registered a long-term interruption of the import of immunosuppressant medicine in 2019 and a drug for gout this year. Despite our efforts and desire to provide quantities from Europe, this has not been possible due to the lack of legislation, about which we have been appealing for 4 years.”

Where do you think the biggest growth area will be in 2021 and how would you like to see the market developing in the future?

“We see the future in solidarity only. Solidarity between economies, Member States and the conviction of mutual assistance in Europe by all politicians and public authorities. In the narrow sense, solidarity means that when one country is in difficulty, another or the whole community will be open to proposing a solution. The post COVID 19 future key is beyond standard thinking and pre-crisis routines. Shortages mitigation, social benefit and market growth is possible if urgent, extraordinary import by wholesalers is allowed in EU and EEA. This regime should be different from the procedures for parallel imports or imports in a non-crisis situation.

Our proposal for emergency imports during a crisis can be considered a proactive measure, one in which the member-state Minister can ban exports with his order. Let him/her then, with an order, to be able to authorize imports for certain medicines. These crisis imports could be allowed within days, not under the procedures for parallel imports to obtain registration and price validation. And if we want to be adequate to the situation, we need blitz solutions. Let each pan European distributor which wants and have the expertise to help, be allowed by law to do it. After the crisis we see the future in fast track resolution of supply by parallel importers and effective measures on encouraging parallel trade of medicines.”

Register your place at: www.parallel-trade.com/boryana