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We are working for broader access to medicines from the common European market

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We are working for broader access to medicines from the common European market

We aim to be the partner with the highest trust in medicinal products and medical devices from parallel distribution in Bulgaria

 

Capital Health, November 23, 2018

 

 

Milena Ivanova
BestaMed Ltd. Manager

BestaMed is a marketing authorization holder from parallel import of medicinal products and medical devices with expertise in providing strategic solutions and services in the pharmaceutical sector. Co-founder of BAMPTD and European Association of Euro-pharmaceutical companies member.

Are you one of the companies that most actively develop parallel imports in Bulgaria, what are the opportunities and challenges for you?

The possibilities are related to ensuring the access of Bulgarian patients to the EU large market scale where the supply is many times bigger than the national one. All medicines and medical devices in the EU are allowed to be used under the same rules and procedures, which means that there should be no barriers to their distribution in each Member State. Over the last 3-4 years, the number of drugs and products that have been subject to parallel import increased. This contributes to lowering their prices in a natural market manner and increasing the competitiveness of the actors in the supply chain.

Challenge is the highly restrictive to parallel import regulations. Amendments to the Ordinance on Prices are necessary because it discourages the placing on the market of prescription drugs from parallel imports. Thus, we can not deploy the full scale to reach more benefits for patients and wholesalers and retailers.

The Law on Medicinal Products in Human Medicine also needs additions in order to be able to respond as quickly as possible to situations of shortage or lack of medicines in Bulgaria, which are also available in other EU countries.

There is also a need for synchronization with the European Commission's instructions, which clearly establishes that different sizes of packaging can be authorized for parallel imports. At present, this is not possible in our country and is detrimental both to patients and to the whole healthcare sector.

What are the benefits for patients from parallel imports?

First is the price competition. Retailers who offer their parallel imported drugs in their portfolio usually reduce the price of the product. In many situations, we are an alternative supplier in a temporary shortage situations - in 3 cases we provided medicines to patients because the initiators had production or logistical problems.

BestaMed participates in the pilot drug verification phase. What are your technological innovations and processes?

For all EU citizens it means enhanced safety and protection against penetration of counterfeit medicines into the common market. Each operator chooses what IT solution to use, but is required to apply it no later than February 9, 2019. We have chosen an Irish supplier whose technology combines complex functionalities for an optimized and accelerated verification process. We have passed successful tests in the pilot phase and we can state that we are one of the first in Bulgaria with a functioning verification system.

our thesis is that parallel import drugs have an additional safety guarantee.

Yes. They are subject to double check on registration - one time from the drug agency of the source country and the second time from BDA in Bulgaria. Adaptation of the packaging takes place in a GMP environment in which the same medicinal products are manufactured. A blister, sachet, and bottle sticker is affixed and this certifies that the product has passed through all stages and procedures approved by BDA.

For six years now, BestaMed planted forests in the country. Tell us about this project.

BestaMed Forest is an expression of our values of care for the environment in which we live, work, raise and educate our children. We can be healthy, successful and happy only when we take care of the world around us. This has revealed to us the cause of social responsibility: BestaMed Forest - We Grow Together! Since 2013, the Forest of BestaMed has reached 400 trees all over the country - Borovets, Tryavna, Stara Zagora, Sofia, Bourgas and Plovdiv. Afforestation is an expression of our understanding of sustainable development, the preservation of natural resources and the creation of high-quality culture. BestaMed Forest is our philosophy of contributing to society followed by our entire team. We plant a forest that grows with us.

See Capital Health article here