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Parallel import in Bulgaria will grow with a more effective regulatory framework

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Parallel import in Bulgaria will grow with a more effective regulatory framework

Parallel distribution (PD) of medicinal products in the European Community has over 40 years of history. Initially, its direction was from Southern Europe to the countries of Northern Europe, but over the past 15 years PD has been the cause of intense and balanced trade in the European Economic Area. Price differences across Europe make it possible for each product to be distributed in a country whit a higher price or shortage and consumers will have the benefit of purchasing it at a lower price.

In 2011 in our country 4 drugs were imported through parallel distribution, now they are 114

Bulgaria has generated more and more benefits from parallel distribution, and in the last 7 years the number of parallel imported medicines increased from 4 in 2011 to 114 according to the Register of the Bulgarian Drug Agency as of 12 March 2018. More and more medicinal products can be imported into our country, with the greatest benefit to Bulgarian patients and the healthcare system of preblockedion medicines reimbursed by the National Health Insurance Fund. BAMPTD strives to liberalize the regulatory framework in order to ease the regime of access of Bulgarian patients to preblockedion medicines from parallel import.

From 20 to 50% cheaper preblockedion medicines thanks to parallel import in Bulgaria

Presently the medicines with preblockedion from parallel import have shown a price effect in favor of consumers of 20 to 50% lower prices of medicines for diabetes, cardiovascular diseases, chronic pain, and so on.

Parallel distribution is a legitimate activity regulated by European law. The name "parallel" comes from its essence - it is trade beyond the traditional distribution network (manufacturer / wholesaler - pharmacy / hospital) established by the manufacturers of medicinal products that sell only through its official representative on that market. Like the rest of the pharmaceutical sector, parallel trade is highly regulated and controlled locally and at EU level.

5% of the turnover of pharmacies in Germany must necessarily be from parallel import

A good example of promoting parallel import at national level with a view to savings for the systems and more affordable prices for patients is Germany. The regulatory requirement that 5% of the turnover of pharmacies be generated from the sale of drugs from parallel import is implemented.

Licensed wholesalers deliver medicines from original manufacturers with a single source the European Economic Area and they are carefully scrutinized under EU and national regulations that apply to pharmaceutical manufacturers. Drugs produced in the same plants and sold through the same channels are the same and similar to the products distributed by the local brand owner but with a lower price.

Any product imported parallel to Bulgaria passes a statutory registration procedure. We can claim that parallel imported medicines have an additional guarantee of safety and origin. The sticker that is affixed to the blister pack, sachet, vial of each medicinal product imported from the EU is the sign that this medicine has an extra safety and quality certificate, namely that it is repacked under the conditions of Good Manufacturing Practice (GMP) and the lot is certified for Bulgaria by a manufacturing company authorized to produce medicinal products.

The Sticker is a sign of strict control and additional safety for patients

The sticker is also placed in order to adapt the product for the Bulgarian patients and to have the necessary information in Bulgarian. The presence of a sticker shows that a very strict internal control of the supply chain has been applied and the repackaging has been carried out in an environment of Good Manufacturing Practice.

The BAMPTD members are proud to be reliable, responsible and professional partners in the healthcare system. The companies in our association comply with a strict Code of Business Practice and apply Good Manufacturing Practice (GMP) and Good Distribution Practice (DDI).

 

Parallel distribution means safety

Parallel distribution is  uncontrovertibly safe. Even if their supplies cross EEA internal borders (which manufacturers often consider a 'complex' supply route), the supply chain of PD is resilient in terms of quality assurance as well as against the entry of falsified products into the legal supply chain. Several business routines make up this result: 

  • Parallel distributors are subject to the same regulatory requirements as manufacturers of branded or generic products and undergo regular controls by the competent national and European regulatory authorities.
  • Importers do not manufacture any medicines themselves, nor open the primary packaging.
  • Importers buy finished medicinal products from exporters who are well-established and authorised pharmaceutical wholesalers.
  • They do not deal directly with the consumers either, rather the parallel distributors’ customer is another licenced wholesaler, a registered pharmacy or a dispensing doctor.
  • All transactions are conducted through officially authorised and controlled trade channels.
  • A wholesale business or a pharmacist simply has one more source to purchase medicines from, which enhances the robustness of the medicines supply chain when manufacturers try to curtail supplies.

 

 

 

BAMPTD fully supports the protection of the interests of Bulgarian patients for unhindered access to medicines at the best possible price and we have repeatedly stated the need for a transparent, objective and non-discriminatory regulatory basis for all economic subjects. As a sustainable partner of the institutions, we actively participate with our expertise in the public discussion of the forthcoming changes in the pharmaceutical legislation.

Parallel trade in medicinal products creates a real competitive environment and helps regulate the prices of medicinal products in the Member States and should therefore be protected, tolerated and encouraged.

Parallel distribution of medicines creates a real competitive environment and helps regulate the prices of medicinal products in the Member States and should therefore be protected, tolerated and encouraged.

The free movement of goods, including medicines, within the common European market is a fundamental and most important principle of the European legislation entitling the European citizens to access medicines from this place in Europe where the prices are the lowest.

Parallel distribution of medicines as well as other goods counteracts price differences between different national markets within the European Economic Area (EEA). Parallel distributors buy products marketed by the original pharmacy manufacturers at a lower price in one country and sell them in another country where the price is higher. Such trading is legal under the rule of regional exhaustion of the trademark owner's right applied in the EU and the EEA.

Benefits from parallel distribution

Parallel distribution creates savings:

  1. It provides original, high quality and safe medicines at a lower cost. These direct savings are a measurable relief of the cost burden carried by health insurance systems and patients.
  2. It provides both indirect savings for social health insurance systems and consumers by effectively curbing overall price increases in the pharmaceutical sector.
  3. It offers a European relief mechanism to funding deficits in national health care systems

Parallel distribution fosters competition:

  1. It provides the only form of competition for patented products, utilizing the price differences in different markets created by the original manufacturer himself.
  2. It accelerates the integration of the internal market and increases trade within the EU and EEA
  3. It helps regulators to avoid implementing more interventionist or market-distorting cost-containment measures
  4. It gives wholesalers, pharmacists and patients a real choice
  5. It can provide alternative supply sources in case of shortages

Parallel distribution builds growth:

  1. It has created thousands of new businesses and jobs in Europe, often in economically deprived regionsIt boosts the infrastructure development for production and distribution of pharmaceuticals in the countries of supply, as well as increasing their exportsIt generates additional tax revenues in Europe and increases the effectiveness of the internal market
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Companies engaged in parallel distribution of medicines are an integrated part of the European pharmaceutical market and the drug supply chain and add value to society by introducing price competition on the market as an additional filter to check product safety. Companies performing parallel distribution of medicinal products are licensed by the regulatory authorities of the respective EU Member State and are working in accordance with the requirements of good practices for the production and / or distribution of medicines.

Parallel distributors of medicines provide savings for public organizations purchasing medicines while ensuring that these medicines are proven in the EU and are part of the legal drug supply chain.

Licensed wholesalers supply medicines from original manufacturers with a single source Europe, and they are carefully scrutinized under EU legislation and national regulations that apply to pharmaceutical manufacturers. Drugs produced in the same plants and sold through the same channels are identical to products that are distributed by the local brand owner but are cheaper.

For more than 40 years patients have been receiving guaranteed parallel trade savings that bring competition to the otherwise closed pharmaceutical market and with improved access to medicines that are subject to limited or problematic distribution.

Parallel distribution provides an opportunity for Bulgarian patients to buy the same original medicines at lower prices and to have access to a variety of medicines in all EEA countries, not just those registered on the local market. In order to widen this access, there is a need to refine and add texts in the current legislation. Thus, this kind of activity can be even more useful for patients and public funds, including for solving situations with a lack and shortage of medicinal products.

Capital Health, 18th, May, 2018

Author: Boryana Marinkova - CEO of the Bulgarian Association for Medicines Parallel Trade Development (BAMPTD).