Supplies by pharmacists to entities other than patients

Definition of Wholesale Dealing  Article All activities consisting of procuring, holding, supplying or exporting medicinal products, apart from supplying medicinal products to the public. Such activities are carried out with manufacturers or their depositories, importers, other wholesale distributors or with pharmacists and persons authorized or entitled to supply medicinal products to the public in the Member State concerned.

Directive 2001/83/EC 2. Where persons authorized or entitled to supply medicinal products to the public may also, under national law, engage in wholesale business, such persons shall be subject to the authorization provided for in paragraph 1. Article 77 1.Member States shall take all appropriate measures to ensure that the wholesale distribution of medicinal products is subject to the possession of an authorization to engage in activity as a wholesaler in medicinal products, stating the place for which it is valid.

THE PRINCIPLES Any supply between two different legal entities, apart from the supply to a patient, requires the supplier to possess a wholesale distribution authorisation This rule applies to any supplier, including a pharmacist or other person authorised to supply medicinal products to the public  The above rule is currently subject to an ECJ reference

ECJ Case C-7/11 Caronna (IT) Is Art 77(2) to be construed as meaning that pharmacists are included among the persons who must obtain authorisation for the wholesale distribution of medicinal products or was it the Community legislature’s intention, instead, to exempt pharmacists from the requirement to apply for that authorisation, as would appear to be suggested by a reading of recital 36…?

 (36) Any person involved in the wholesale distribution of medicinal products should be in possession of a special authorization. themselves to this activity, should be Pharmacists and persons authorized to supply medicinal products to the public, and who confine exempt from obtaining this authorization.

Questionnaire UK plus 12 MS (BE, BU, CZ, FR, DE, IS, IE, L, MA, NO, SE) 1.How is the hospital sector organised in your country i.e. state provision only or mixed economy between state and private hospitals? Answer: Two MS State Only; the remainder mixed economy between state and private providers. 2.Is each hospital a separate legal entity? Answer: in four MS answer “yes”. In others, “some” or “most”.

WDA for inter-hospital (different legal entity) supplies? 3. 3.If a hospital pharmacy is engaged in the wholesale supply of medicines to hospitals in another legal entity, clinical units, wards or departments of another legal entity that are co-located on the same site, is a wholesale distribution authorisation (WDA) required by the hospital which is supplying?

  Answer: In UK and IE some hospital pharmacies do have a WDA. In UK currently some smaller hospitals or wards or departments of other hospitals which are co-located with large hospital may be supplied by the larger hospital body even though they are separate legal entities without a WDA but this is not expressly permitted by legislation. In IE this practice is permitted by legislation. NO requires a WDA for all inter- hospital supplies.

FR allows inter-hospital supplies without a WDA by special permission for a limited period of time, but this is not considered to be wholesale authorisation. DE was unsure. CZ seem to say that they do not regard supply to other (separate legal entity) hospitals as wholesale distribution. The remaining MS state that their hospitals do not supply to other (separate legal entity) hospitals.

Right of return of unused medicines without a WDA? 4.Can a hospital, pharmacy or ward return for reissue unused medicines to the originating hospital pharmacy (in another legal entity), without requiring a wholesale dealer’s licence? Answer: UK, BU and IE: yes. In UK, where this occurs between two separate legal entities we believe that this would constitute wholesale dealing and we are reviewing the legislation. In CZ medicines may be returned only in the case of a warranty claim or in exceptional cases (without need for special permission). DE and FR unsure. In BE, IS, MA, NO and SE unused medicines may not be returned.

Contracting out of pharmacy services 5.Are hospitals are permitted to contract-out pharmacy services in your State? Answer: In UK, FR, IE and SE: yes. In UK, we are only aware of one hospital that has done so. DE was unsure. In BE, L, MA and NO: no.

Sweden A County Council acting as a single legal entity for a group of hospitals under its control may fully or partially contract out pharmacy services (for example, to a licensed pharmacy or even a wholesaler without a pharmacy licence). Typically, the process/ procedure followed under the contract between a county council and the contracting hospital pharmacy (a company of another legal entity) is that the contracting pharmacy company procures the medicinal products required under the contract, or buys medicinal products not covered by such contracts, and keeps them in store. The medicinal products are then further distributed to the hospital wards, clinical units or departments as requested by them. The contracting pharmacy staff register the order and assesses whether it is reasonable with regard to the activities of the ward/ department. The ordered products are then gathered and delivered after a final control by a pharmacist. The rules on good distribution practice apply to contracted pharmacy/ wholesale dealer.

CONCLUSIONS and QUESTIONS 1. There is a variety of practice in contracting out of pharmacy services 2. There is a variety of practice and interpretation of the Directive rules in relation to inter-hospital (different legal entity) supplies and right of return of unused medicines without a WDA. 1. – Probably not a concern. Is a matter for national hospital systems Should we be concerned? Public Health risk? Counterfeits? 3. Is the Italian situation as evidenced in Caronna applicable in your country? Another questionnaire? Again, should we be concerned?