3.19 Generic medicines occupy a natural place on the market
Generic medicine is a copy of an original medicinal product. The generic product can be manufactured and sold when the patent on the original product expires.
Patented medicinal products are newly developed medicines and are often referred to as original medicines. This means that the medicine is the first of its kind (new active substance) used for treatment of a given disease and will, therefore, usually be subject to patent protection.
The foundation for the development of new medicines and therapies is adequate patent protection. When a patent expires, it is equally natural that the product can be legally copied, manufactured and distributed by other authorised manufacturers. Generic medicines are also called me-too drugs. Often several companies will copy the original medicines at the same time. Generic products must not be confused with counterfeits
Generic medicine contains the same active substance, and in the same quantity, as the original medicine, but since the development costs have already been defrayed, generic products will typically be considerably cheaper than the original products. Since medicines contain various additives and excipients apart from the active substance, patients may experience a different effect and/or adverse reaction from use of generic medicine.
As a general rule, pharmacies must dispense the cheapest medicinal product, original or generic, unless the doctor has stated otherwise on the prescription. The structure of the reimbursement system, combined with the keen competition in the field of medicines, means that patients will experience that, time and again, they have to switch between generic medicines from different generic producers. According to the reimbursement rules, patients who do not tolerate the cheapest medicinal product are able to obtain increased reimbursement after application to the Danish Medicines Agency.
Lif believes:
- that it is only natural that generic medicine will take over a substantial part of the market share after expiry of the patent,
- that the use of the cheapest generic medicine will increase the financial scope to introduce new medicines and therapies,
- that unnecessary switches between various medicines should actively be restrained with new rules against negligible price changes and higher requirements as to the delivery performance of the enterprises.
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