The Polish Ministry of Health has recently published two draft amendments to the Act on Pharmaceutical Law. They implement the EU directives with regard to the prevention of the entry into the legal supply chain of falsified medicinal products (Directive 2011/62/EU) and pharmacovigilance (Directive 2010/84/EU).
Falsified medicinal products
The first amendment introduces to the Polish Pharmaceutical Law the requirements set out in the Directive 2011/62/EU concerning falsified medicinal products. In particular it adds to the glossary the definitions of ‘falsified medicinal product’, ‘active substance’ and ‘excipient’.
According to the amendment, manufacturers, importers and distributors of active substances will be obliged to comply with Good Manufacturing and Good Distribution Practices. The conformity of manufacturing and distribution of active substances with these practices will be verified not only by the Pharmaceutical Inspection, but also by obligatory audits conducted by manufacturers and distributors of medicinal products. Any instance or suspicion of falsified medicinal product will have to be reported to the Pharmaceutical Inspection as well as to the marketing authorization holder.
Definition of brokers
In light of an increasingly complex distribution network for medicinal products, the amendment follows Directive 2011/62/EU in addressing a new category of actors in the supply chain, i.e. brokers of medicinal products. According to Directive 2011/62/EU, brokers are the persons involved in the sale or purchase of medicinal products without selling or purchasing those products themselves, and without owning and physically handling the medicinal products. This meaning of brokers is hardly reflected in the Polish implementation which states that: brokering are activities in relation to the sale and purchase of medicinal products, except for wholesale distribution and physical possession or supply, consisting in independently negotiating on behalf of another legal or natural person.
Firstly, the Polish definition seems to be self-contradictory as it is impossible to act independently and on behalf of another person at the same time. Secondly, and most importantly, the definition may be interpreted to cover persons who are not brokers of medicinal products within the meaning of Directive 2011/62/EU, e.g. external attorneys at law acting on behalf of pharmaceutical distributors and negotiating distribution agreements.
This could lead to absurd consequences in practice. According to the amendment every broker will be obliged to fulfil specific requirements. Hence, provided that the wording of the definition is not changed in the legislation process, an attorney at law representing a pharmaceutical company in negotiations concerning sale or purchase of medicinal products would have to register with the competent authorities, comply with the Good Distribution Practice, inform the Pharmaceutical Inspection on falsified products, etc.
Moreover, the pharmaceutical distributors could appoint only those attorneys at law who would fulfil the requirements set out by pharmaceutical regulations for brokers. It seems that in order to prevent such situations, the wording of the Polish definition of brokering should be corrected.
Sale of medicinal products on the Internet
Considering that the majority of falsified medicinal products are sold to the public via the Internet, the amendment addresses also the retail supply of medicinal products offered through distant selling by means of electronic communication.
Accordingly, pharmacies intending to sell medicinal products via the Internet will be obliged to notify the Pharmaceutical Inspection at least 14 days prior to the commencement of such activity. This requirement already exists in the Polish pharmaceutical regulations. However, so far, it was solely contained in the executive act that is the Ordinance of the Minister of Health and not in the Act on Pharmaceutical Law itself. Any modification of the data provided in such notification will have to be communicated without undue delay to the Pharmaceutical Inspection. A failure to satisfy the notification requirements as well as selling via the Internet prescription products might be sanctioned with revocation of the authorisation for retail distribution.
The minimum information standards for the Internet pharmacy website will be specified by the Minister of Health in a separate executive act. They should provide for the requirement to use a common logo identifying websites which are legally offering medicinal products to the public through distant selling.
The second amendment regards pharmacovigilance issues. The major changes concern the obligation of the marketing authorisation holders to report the suspected adverse reactions to the EU-wide pharmacovigilance database, known as ‘Eudravigilance’.
The amendment facilitates the reporting of suspected adverse reactions directly by patients or their representatives. They will be able to communicate suspected adverse reactions both to the marketing authorisation holders and to the Drug Registration Office. On the other hand healthcare professionals will still be obliged to report suspected adverse reactions directly to the Drug Registration Office.
Following the amendment, an appropriately qualified person responsible for pharmacovigilance will have to be at the disposal of parallel importers on a permanent and continuous basis. So far this requirement concerned exclusively marketing authorisation holders.
The Drug Registration Office will gain new competences with regard to pharmacovigilance. This includes the possibility of imposing financial penalties of up to PLN 50.000 (ca. EUR 12.500) and suspending or even revoking a marketing authorisation in case of failure to report an adverse reaction.
Additional fee for marketing authorisation
Apart from implementing the provisions of Directive 2010/84/EU, the second amendment also introduces an additional fee for marketing authorisation holders for the activities related to pharmacovigilance.
The fee will amount to up to PLN 3.000 (EUR 750) (the exact amount will be specified by the Minister of Health in a separate executive act) and will be levied on an annual basis for each marketing authorisation held by the given holder. It will constitute an additional income source for the national budget.
Both drafts are currently forwarded to the Permanent Committee of the Council of Ministers and will be probably soon be sent to the Polish Parliament for enactment.
The drafts can be found here