On 12 July 2015, the new amendment to the Pharmaceutical Law on the limitation of parallel exports, will enter into force. Apart from the regulations providing that blacklisted medicinal products will not be able to be sold abroad without prior consent of the Regulatory Authority (which is the core of this amendment), it will also impose new reporting obligations on the marketing authorization holders (“MAHs”) and warehouses (Article 36z of the Pharmaceutical Law). The Regulatory Authorities want to know everything about the marketing of medicinal products in Poland, to avoid a situation where medicinal products are unavailable to Polish patients even though they were sold and dedicated for the Polish market. The parallel export of drugs has intensified recently due to differences in prices of reimbursed medicinal products across the Member States.
At each request from the Ministry of Health or the Main Pharmaceutical Inspectorate, MAHs and wholesalers will be obliged to provide those authorities, within 2 days, with various current and detailed information (including stock volumes, released batches, the disposal of medicinal products on the market). Non-compliance with that obligation is sanctioned by a fine of up to €12,000.
Warehouses will be obliged to justify all of their refusals to sell any reimbursed medicinal products. Copies of all refusals will have to be sent to the Regulatory Authorities and the failure to provide such justification may even result in the withdrawal of the distribution license. What is more, all orders and refusals will have to be in writing or sent via e-mail. Customers (such as pharmacies, distributors, healthcare centers) will not be allowed to place orders by fax or telephone. The paper or electronic orders must be archived for 3 years.
As a result of these amendments, some changes in the organization of work may be necessary. In many cases a change of the MAH's representative agreement will be required. Moreover, the situation can be complicated for those MAHs who do not manufacture the medicinal products themselves. For example, the following questions may arise: Is the MAH obliged to provide the requested information about the stock volumes, if the medicinal products are manufactured by another company? Does the information concern the medicinal products that were sold in Poland, in the European Union, or worldwide? What does the “refusal to sell” mean and what are the circumstances that make such refusal justified? May the MAHs advise/help their distributors as to how to behave in the case of a refusal, or is this forbidden under competition law?