Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Requirements an opportunities of an OTC-switch – Comparison between Germany, UK and USA ***

Kirsten Vonde (Abschlußjahr: 2001)

Products which are available for self-medication are becoming more and more important for patients, for pharmaceutical industry and also for health care systems. Patients or consumers for example are getting a huge amount of information about health, diseases and medicinal products from the Internet. As a result of their knowledge the patients want to decide self-responsible about medicinal products they take for the treatment and prophylaxis of diseases or for life style reasons. The primary drive of the industry to switch a product is life cycle management of an established brand before patent expiry. Furtheron an OTC switch is an advantage for health care systems as medicinal products which are sold for self-medication are not reimbursed and the patients are not consulting a doctor for minor diseases they can treat on their own. OTC products are therefore saving money both directly and indirectly.

Even if the general requirements to switch the legal status of a medicinal product from Rx-to-OTC are comparable in Germany, the UK and in the USA, the lists of drugs which can be sold without a prescription from a practitioner in the three regions are very inhomogeneous. Furtheron the advantages resulting from an OTC-switch are not the same in these three regions.

The national requirements on OTC products are all based on the WHO Guideline for the Regulatory Assessment of Medicinal Products for use in Self-medication and are mainly focussing on the safety of the drug product and on the question whether the product is appropriate for self-medication. Furtheron special requirements regarding the labelling of an OTC drug product are formulated. In addition to the safety concerns the effectiveness of the drug product is stated as one requirement for an OTC switch in the USA. In Europe a proof of the effectiveness of a drug product is not covered by the requirements for an OTC switch as this is an essential requirement for the approval of an MAA.

The procedure of an OTC switch is substantially different in the three regions compared. These differences are based on a historical background. While in Germany and in the UK a switching application always deals with a drug substance, in the USA a switching application might deal either with a group of drug substances indicated for the same or for a comparable indication (OTC Drug Review) or it might deal with one special drug product (OTC NDA).

The OTC switching procedure itself is starting with the receipt of a switching application at the authorities in Germany and in the UK followed by the discussion in external Expert Committees and the decision whether the switching application will be recommended or not. If the switching application will be recommended the responsible ministry will publish an amendment to the order stating those drug products which are available on prescription only.

In the USA there are two possibilities to apply for an OTC switch either the OTC Drug Review system, which is also known as the monograph system and which is comparable to the systems described for Germany and the UK, or the OTC NDA system. If the MAH wants to market an OTC product under the authority of an approved NDA either because there exists no OTC monograph for this drug product or because his products deviates from the OTC monograph he has to apply for a new Marketing Authorisation via an NDA. The general way of reviewing NDAs will be followed afterwards. With approval of the FDA a deviation NDA (dNDA) can be submitted, which requires a lower amount of documentation to be submitted together with the NDA.

Several changes in the requirements and opportunities of a medicinal product are resulting from an OTC switch. In Germany and in the UK the labelling requirements are slightly changing in a formal way, but the content of the labelling stays the same after an OTC switch. In the USA the labelling requirements for a medicinal product are totally changing as a result of an OTC switch according to the final rule on labelling requirements for OTC drug products published in 1999. Reimbursement for OTC drug products is theoretically possible on the same rate as Rx pro-ducts in Germany. In the UK OTC products are not reimbursed at all, but products can have dual status so they can be available Rx and OTC. Reimbursement for the Rx product is maintained then. In the USA there is no reimbursement at all and insurance companies do not pay for OTC drug products. In the UK the Resale Price Maintenance was set out of force for OTC drug products by the High Court in the UK in May 2001. This means that the pharmacies have to decide now on a business orientated basis which price the consumer has to pay for an OTC drug product in this pharmacy. In Germany and in the UK advertising to the general public is not permitted for Rx products, therefore the MAH can directly contact the consumers of his drug products only after switching a product OTC. In the USA DTC advertising is allowed for Rx products as well as for OTC products, but DTC advertisement for Rx products is restricted according to the CFR.

One of the major advantages of Rx-to-OTC switches is the reduction of health care costs. The availability of OTC products may save millions by reducing the number of physician visits and also the associated costs of a physician visit in travel and time lost from work.

The legal status of medicinal products approved in a centralised procedure is defined on a European basis and is identical in all parts of the European Union, in contrary the legal status of medicinal products approved on the basis of Mutual Recognition will be defined on a national basis and might be different in the Member States. As an OTC switch might lead to amendments in the SPC of a drug product (re-formulation of the indication, update of contra-indications) these national decisions might lead to problems in the MRP afterwards.

In the future the implementation of the CTD will have an impact on the OTC NDAs in the USA only, while the Review 2001 will have a direct impact on the switching procedures in Europe based on the requirement to harmonise the legal status of medicinal products approved on the basis of Mutual Recognition. A proposal of a procedure to implement this harmonisation is not included in the Review 2001 document.

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