Pharmaceutical wholesalers act as agents between drug producers and pharmacies. They allow pharmacies to meet their statutory obligation of providing medicines to citizens. Their operating standards are strictly defined in the law.
Pharmaceutical wholesalers supply medicines to pharmacies, but – since medicine distribution involves the supply of a special type of products – they do not operate under the conditions of a market controlled only by supply and demand.
The main role of wholesalers is to provide access to medicines. Their tasks also include the maintenance of stock and assortment availability, timely deliveries and financing the medicine flow.
Legal basis for operation
The medicine distribution market is strictly controlled by law. The distribution regulations are set out primarily in the pharmaceutical law and the so-called Reimbursement Act.
To open a pharmaceutical wholesale store, a permit must be obtained from the Main Pharmaceutical Inspector. Before an application can be submitted, this should be preceded by acquiring an opinion of the voivodeship pharmaceutical inspector on the suitability of the premises designed to house a wholesale store and an opinion of the Chief Sanitary Inspectorate on the premises.
An entrepreneur deciding to open a pharmaceutical wholesale store should hold adequate sites, employ a manager – a person responsible for managing the store. The manager must have a degree in pharmacy and a minimum two years of experience working at a pharmaceutical wholesaler store or pharmacy.
The statutory responsibilities of wholesalers include the purchase of medicinal products only from entrepreneurs producing medicines or conducting wholesale. Wholesalers can only supply medicinal products to authorised entities, including generally accessible pharmacies, health care establishments, pharmacy points, and physicians operating individually or in group medical practices. Wholesalers must also submit to the Minister of Health reports on the volumes of medicinal product sales.
Standards of Good Practice
Pharmaceutical wholesalers must obey the standards of Good Distribution Practice defined in the 2002 resolution of the Minister of Health. They set out the rules of medicinal product storage, requirements concerning premises’ technical and sanitary conditions, rules and modes for collecting and releasing medicinal products, and conditions for the transport and loading of medicinal products.
These regulations determine the temperature and humidity in the warehouse and the mode of inspection of whether the product’s packaging complies with the applicable requirements.
The wholesale of controlled products, i.e. those containing intoxicants and psychotropic substances, is even more restrictive and governed by the Act on counteracting drug addiction.
Proposals to raise the wholesale margin for drugs
The Reimbursement Act, which entered into force on 1 January 2012, introduced fixed official prices and margins for reimbursed medicines.
In 2012, the wholesale margin was 7 percent of the official sale price, in 2013 - 6 percent, and from 2014 it is 5 percent.
Representatives of the pharmaceutical wholesale market are opting for the raise of the margin to a minimum of 6 percent, as – in their view – this is the threshold of profitability.
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