The so called original medicines are pharmaceuticals which are based on new chemical entities (NCE’s), new biological entities (NBE or Biologics) or a new formulation of an already known substance, the latter are often called speciality pharma. In order to get maximal earnings from the often very large investment in the development of the medicine, the pharmaceutical company almost always apply for a patent, and in this way gets the exclusive right to sell the product for a number of years. When the patent expires, other companies may manufacture equivalent medicines, called generics or generic medicines. In this way competition is created which contributes to great savings for both the society and the consumer. In several countries, e.g. Sweden and Denmark, rules exist concerning substitution, meaning that the pharmacies must replace prescription medicines with the cheapest available alternative. This contributes to a reduction of the society’s cost for prescription medicines.
Generic medicines contain the same active pharmaceutical ingredient in the same amount as the corresponding original medicines. The excipients may vary, and therefore the medicines may differ in appearance. Generic products carry a different name than the corresponding original drugs, but provide the same medical effect.
A generic medicine has the same quality- and safety profile as the original medicine. Generic medicines are often tested in clinical studies in healthy volunteers to ensure that they are equivalent to the original medicines. During the entire development- and production process the generic medicine must comply with the same standards of efficacy, safety and quality as the original medicine. The requirements are monitored and enforced by the relevant regulatory authorities (the national medicines’ agencies and the European Medicines Agency (EMA) both before and after the medicine is approved for sale. The Medical Products Agency decides which medicines are substitutable.
Parallel import of a medicine means import of a medicine into Sweden from another country within the European Economic Area (EEA). The so called direct imported medicine must already be approved for sale in Sweden. The imported product must also be approved in the country of export. Medicines which are parallel imported can be original medicines or generic medicines.
A parallel imported medicine always contains the same active ingredient and has a comparable composition as the directly imported medicinal product. The medicine often has the same name as the direct imported medicinal product, but may also have a different name. Differences in the appearance of the parallel imported product compared with the directly imported product may occur but is not common.
Just like the direct imported product the parallel imported product must obtain an authorization by the Medical Products Agency in order to be sold in Sweden. In some cases, it is the European Medicines Agency (EMA) that issues the authorization instead. The medicine is then called parallel distributed instead of parallel imported. A parallel distributed medicine is exactly the same pharmaceutical as the direct imported medicine.
The parallel imported or parallel distributed medicine is re-packaged or re-labeled in Swedish and provided with a Swedish package leaflet by an approved re-packager before it is distributed to the Swedish pharmacies.
The parallel imported medicines are usually cheaper in their countries of origin than in Sweden, which means that the pharmacies can buy them from the importer for a lower price. For the patient, this may result in lower medicine prices, as the manufacturer of the medicine may lower its prices to compete with the importer. In this way, significant cost savings are generated for the society.