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Modernising online pharmacies' regulation under Bulgarian law for embracing innovation and digitised supply chain solutions

Modernising online pharmacies' regulation under Bulgarian law for embracing innovation and digitised supply chain solutions

Mrs. Zlatina Ruseva-Savova is the Managing Partner of Dinkov, Maximova, Ruseva-Savova, a preferred corporate law firm rendering a quick response, world-class quality and solution-oriented legal services. She has long-standing experience in advising multinational life-sciences and pharma companies and associations on their strategic projects and overall Bulgarian operations.

Dinkov, Maximova, Ruseva-Savova - LLP

16, Sveta Nedelya Square
Floor 2
Sofia 1000, Bulgaria
zruseva@rslaw.eu
www.dmrslaw.eu

Does current Bulgarian legislation answer the needs of e-pharmacies?

According to a recent study of the top pharma supply chain trends, conducted by CosmoTrace, online pharmacies are expected to grow further in 2022 and beyond.

The increasing complexity of the supply chain ecosystem and innovative eCommerce models bring about the need for the adoption of upgraded, new legal provisions with regard to sales of Over-the-Counter ('OTC') medicines by online pharmacies. With good reason, projects in this area are created and operated as agile processes.

Can you outline some proposed legislative changes?

Currently, effective Bulgarian legislation does not provide workable solutions to meet the evolving needs of online pharmacies and consumer attitudes. Identified areas of improvement that would address supply chain bottlenecks include, for example:

-- Possessing the 'right of use' of a website (sub-domain) of a third-party is not covered under current legislation, but an online pharmacy is required to have an 'own' Internet website, although the effect may be the same in both cases in practice;

-- B2B integration platforms and certified third-party sellers could be introduced, so that consumers will be able to enjoy access to a broader range of products;

-- Embracing flexible transportation/shipping and direct-to-patient delivery patterns would ensure same-day drug delivery throughout the country. One possible legislative change could be that e-pharmacies are expressly allowed to deliver OTC medicines to the customers by also using licensed transportation vehicles of a third-party seller (eCommerce partner) in contrast to "own ones or at their disposal", where all temperature storage, relative humidity, direct sunlight and other applicable transportation conditions shall be complied with. International and humanitarian aid law permits for medicines to be transported even by airplanes, which obviously are not owned or held by their retail sellers;

Adopting such amendments would increase the value-based healthcare, competitiveness and will make existent state-of-the-art European solutions available to the Bulgarian consumers too.

How to mitigate patient health-related risks while modernising online sales of medicines legislation?

Observing good distribution practices, on-demand distribution process visibility and transparency are needed at all times. It would be feasible to also introduce a regulation for Good Distribution Practice in the online sale of medicinal products, as there is currently only one relating to wholesales.

Putting quality assurance system and processes in place, following the model of countries such as Germany, for example, would facilitate trust among all stakeholder. This measure could be either mandatory or voluntary, as quality checks are performed by multinational players in any event. Assuring good patient-pharmacist connection for adequate treatment is crucial.

Introducing "new pathways of implementation of the supply chain to patients without jeopardising their health" has been addressed in academic publications (for example, S. Kochev, M. Pesheva, E. Grigorov (2015b).

How do you see e-pharmacies of the future?

Some European Union ('EU') Member States have already made a shift. German, Danish and other online pharmacy platforms deliver medicines across the EU. In Germany, OTC drugs can be mailed to patients globally, but "import regulations of the receiving country should be verified in advance". According to the European Parliament: (i) in southern EU Member States and Germany "online purchases of medicines are not allowed if they are on prescription in the country of destination"; while (ii) in the Scandinavian states online sales are possible "as long as online pharmacies do not actively advertise in other Member States".

Bulgaria is following the approach of Austria and France where e-pharmacies are allowed to sell OTC medicines only. Other countries such as Germany, Denmark, Spain, Italy and Sweden have also allowed prescription drugs to be sold over the Internet, as allowed by Directive 2001/83/EC. Prescriptions issued by doctors or dentists in other EU/EEA countries can be dispensed by a Danish pharmacy.

Blockchain technology will continue to increase its importance in the distribution of drugs for detecting low-standard and counterfeit medicines that enter the supply chain.

References:

https://blog.cosmotrace.com/serialization/top-8-pharma-supply-chain-trends-2022

Art. 41, Para. 1 of Regulation No. 28 of 9.12.2008 on the structure, procedure and organization of the work of pharmacies and the nomenclature of medicinal products ('Regulation No. 28').

Art. 42, Para. 2 of Regulation No. 28.

"Online trade with medical products - essence, aspects, function", Varna Medical Forum, Vol. 4 (Suppl. 2), 183.

Distribution and Marketing of Drugs: Jurisdictional comparisons, European Lawyer reference series, the Chapter on Germany by Dr. C. Willhoeft and Field Fisher Waterhouse LLP, 2013.

www.europarl.europa.eu/doceo/document/E-8-2018-002879_EN.html.

www.mdpi.com/journal/pharmacy.

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