Bulgaria must remain in solidarity for the EU to be open to us
CEO of Bulgarian Association for Medicines Parallel Trade Development (BAMPTD)
In 2019, our platform for missing medicines signals won first prize in its category in Innovation and Good Practices in the Health Sector Capital weekly Competition. Only a year later, its importance was proven again. We have created the platform, firstly, 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
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 one of the immunosuppressants 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.
Medicines - economic fugitives
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.
Trying to be constructive and even more useful, we are looking for ways to simplify the procedures by which imports are made. Since 2016, we have been submitting our proposals at each opening of the Law on Medicinal Products in Human Medicine, but, alas, so far we have no development, both on our proposals for facilitated import and import of drugs withdrawn from Bulgaria for economic reasons.
In recent weeks, the hot topic has been low molecular weight heparins - we have had signals and we have been able to cooperate through wholesalers and retailers. We have checked through our partners in Europe and we know that we can import a certain amount from some countries. At the moment, however, this cannot be done because the law does not allow it. We are not talking about a standard parallel import here, because the procedures take more than 120 days, i.e. ideally 4 months.
Export bans are not a solution
The solution lies 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 European Commission's guidelines are unequivocal:
Guidelines for border management measures to protect health and ensure the availability of goods and essential services EC of 16 March 2020:
„Member States must maintain the free movement of all goods and, above all, ensure the supply chain of essential products such as medicines, medical equipment,…. There must be no restrictions on the movement of goods in the single market, especially when they are are related to health…“1
Guidelines on the optimal and rational supply of medicines to avoid shortages during the COVID-19 outbreak of EC from April 8, 2020:
„Member States are expected to protect public health in a spirit of European solidarity. It is therefore critical to lift the ban on the export of medicines within the internal market. Measures leading to requisitioning of medicines, intermediates or APIs, or their production, should not be considered as an option.“2
Prohibition of any kind is a problem, because through prohibitions and raised barriers we cannot ensure what is not imported. If Bulgaria closes, where will we expect the medicines we rely on to come from? Do we think isolation is the solution?
The solution is beyond standard thinking and pre-crisis routines. What is necessary, in our opinion, is the possibility for urgent, extraordinary import during the emergency situation, which will allow the public administration, the Minister of Health, with its explicit act to assign the immediate solution of problems in the supply of medicines through emergency deliveries only and only during a state of emergency by wholesalers. This regime should be different from the procedures for parallel imports or imports in a non-crisis situation. We have proposals that we have made before the pandemic in the last few changes to the LMPHM. Solutions must be sought, not barriers to be raised - this is our appeal.
And I ask the rhetorical questions - Who is confused and why for 4 years now the possibility of fast import by wholesalers, when the holders of marketing authorizations are experiencing difficulties is not accepted?
Why is Bulgaria not allowed to receive additional aid for the supply of medicines when this is possible and there are businesses willing to do so?
Our proposal for emergency imports during a crisis can be considered a proactive measure, one in which the Minister can ban exports with his order. Let him then, with his order, be able to authorize imports for certain medicines. Here we are talking about drugs that are already registered in Bulgaria - they are from the same manufacturer, but are not available whether due to overconsumption and the fear of people or for other reasons. We are talking about the same drugs, with the same active substances and with the same dosage form, only in some cases with different package sizes. These crisis imports could be allowed within days, and I emphasize - not under the procedures for parallel imports to obtain registration and price validation, which requires a minimum of 120 days. And if we want to be adequate to the situation, we need blitz solutions. Let everyone who wants and have the expertise to help, be allowed by law to do it.
I will return to solidarity. It is a gift for countries like Bulgaria, which are small but part of a large, strong team such as the European Union. Let the Bulgarian patient have access to a pan-European market, when one country suffers from a shortage, the product can be imported from another one within the large European community of 500 million.