He is a young passionate person who started very early in the digital world which opened the doors of a world full of opportunities. He will be particularly interested in e-commerce, a sector of the future that only smiles to the most persevering and motivated.
The young Bosnian has read, searched and finally found what he wanted since the beginning of his adventure: financial freedom. His journey has allowed him to acquire specific skills not only in the digital world, but also in the world of business in general.
Benjamin Muminovic is a young entrepreneur of 23 years old who has generated today more than 2 million euros of turnover.
He is no longer a simple player in this vast field, but a specialist. He masters the import-export sector and is, in fact, one of the people best placed to talk to us about the import-export of pharmaceutical products. He did not decline our request for an interview and therefore honors us by answering our questions.
What is the procedure for importing pharmaceutical products Mr. Benjamin Muminovic?
In order to be eligible for import, all pharmaceutical products must follow a specific and common procedure. They must be accepted and therefore subject to the authorization of the Ministry of Public Health. No type of product escapes the rule. And to get this authorization, they must meet the two necessary conditions:
– The one who imports must have an authorization to practice the profession of pharmacist, manufacturer or importer. This is the kind of title that is granted only by the General Secretariat of the Government.
– This one must have the approval of the pharmaceutical speciality, granted by the Ministry of Health. A request for authorization to import pharmaceutical products necessarily includes the name of the specialty to be imported. And that’s not all, it also includes the form of presentation of the product, the name of the foreign manufacturer, the authorization of the importing laboratory, as well as the composition of the product.
What about moving with products?
Indeed, in addition to the necessary standards, there is the movement of products. You can import certain pharmaceutical products for human or veterinary medical use without paying customs duties or value added tax (VAT).
These products can be used by people or animals coming into the European Union (EU). For individuals, you can only import the amount of products necessary to meet your needs while in the EU.
You must present a letter from a doctor or veterinarian confirming the need for the products.
The shipper of the goods must:
– Attach the above-mentioned letter to the outside of the package and mark it “customs documents”.
– Provide information on the goods to the postal or courier service handling the package. This cargo information should include the following: an accurate description, a commodity code, and the value.
– Label the package with the appropriate notation.
The courier or postal service handling the package can use this information to complete an electronic customs declaration using the tax authorities’ Automated Import System (AIS). On this customs declaration, they must: declare that the goods are pharmaceuticals for a specific purpose (to be specified) and enter the code C19 in field D/E 1/11 of the declaration.
Is it necessary to have a patent?
Yes, the patent is necessary. Pharmaceuticals are not products to be taken lightly. They are special because they affect both public health and the economy. This justifies the strong regulation.
Indeed, firstly, the patent imposes standards for the common good. Not just anyone is allowed to sell, manufacture, use or hold for commercial use a pharmaceutical product in the territory covered by the patent. Secondly, there is a supplemental certificate that is issued to extend the patent protection for 5 years. Basically, you understand that in order to protect pharmaceutical products, everyone has to go through certain steps.
It is important that, first of all, the freedom of exploitation of the product is assured. Then you have to examine whether the product is patentable and meets the requirements. Within this framework, a strategy must be created, executed and finally the rights obtained must be enforced.
What are the requirements for an affordable version of a patented product?
There are Health Canada requirements that apply when you want to supply an affordable version of a patented product to an eligible importing country. The first step is to ensure that the Minister of Health gives the Commissioner’s approval that the drug is in compliance with the Food and Drugs Act. Then, a review is done by Health Canada to determine if the product meets Canadian standards. The manufacturer itself must be able to distinguish the product from the original version sold in Canada.
There are also requirements imposed by the Canadian Intellectual Property Office (CIPO). They consist of the mandatory completion of approximately 4 to 5 forms that can be found directly on the Office’s website. You must create a website to disclose product information. As a manufacturer, you must also pay a fee. Every 15 days before an export, an export notice must be sent to the patentee, the importing country, as well as to the person who purchased the product.
What is the parallel import of pharmaceutical products into the European Union?
The interest of parallel imports of pharmaceuticals is the arbitrage between countries with different prices. For several years, an important issue in the European Union (EU) has been the obvious conflict between the different price regulations in the member states on the one hand and the consequences of parallel trade on the other.
In the EU, as long as the manufacturer has placed the good on the market voluntarily, the principle of free movement of goods allows individuals or companies within the EU to trade goods across borders. This can even be done without the consent of the producer. In this context, the authors study the effects of parallel trade in the pharmaceutical industry.
They develop a model in which an original manufacturer competes in its home market with parallel importing firms. The two key assumptions of their theoretical analysis are: first, if the potential for parallel imports is unlimited, the manufacturer chooses deterrence, and international prices converge.
Second, if arbitrage is endogenously constrained, the manufacturing firm adapts, and the price in the home market falls as the volume of parallel trade increases.
When we talk about parallel imports of pharmaceuticals, we are talking about a significant volume of the drug market in Europe. It is legal only if it does not have a negative impact on public health or on industrial and commercial property. Beyond that, it is considered illegal.
Parallel importation is part of the free circulation. However, there is a procedure. Indeed, a license must be obtained. And here, the procedure seems simpler. First of all, the medicines must have received a marketing authorization in the Member State of origin. They must be sufficiently similar to another product that has already received a marketing authorization in the member state of destination.
Muminovic Benjamin what to remember about the global trade in pharmaceuticals?
The pharmaceutical industry is incredibly valuable and continues to grow. We are talking about $1,203 billion in global market sales in 2020. The United States is by far the largest importer of pharmaceuticals in the world. France is ranked 5th in the world, but its market share has fallen by 2.2 points in ten years. It should also be noted that the United States is the leading importer of drugs from France.
Medicines were France’s 4th largest trade surplus in 2020. It was also the only sector to contribute positively to the evolution of exports.
The pharmaceutical industry represents tens of billions of dollars in international trade each year, much of which comes from Europe and the United States.