Planned legislation would reduce available generic drugs

Measure likely to increase costs for patients, and KELA

Sinikka Mönkäre

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Legislation is under preparation at the Ministry of Social Affairs and Health which would extend the time that name brand medicines are protected from competition by generic alternatives.
      If the measure is passed, the National Agency for Medicines estimates that it would sharply reduce the number of generic drugs available. About 800 of the 2,000 drugs for which a generic version is now available would be protected from competition.
     
The pharmaceutical industry has demanded the change. A large American drug manufacturer noticed last winter that Finnish patent legislation allowed the marketing of generic alternatives already before a drug’s patent protection had run out.
      The sticking point is the Finnish law on methods patents, which has been in force since 1995. The law gives 20-year protection to the method of production of a particular drug. However, the documentation protection of the original medicine expires just six years after the drug has been approved for sale.
      This means that generic copies of the original product can be legally sold if they are produced by different methods.
      Under the proposed changes, generic alternatives would not be allowed before the full methods patent period has elapsed.
     
The effect of the new law would be higher costs for patients, and for the Social Insurance Institution (KELA), which pays partial reimbursements for prescribed medicines.
      The Minister of Social Affairs and Health, Sinikka Mönkäre, (SDP) has long supported the possibility to use generic alternatives.
      "I have not changed my mind, but Finland cannot be a loophole that offers better advantages for manufacturers of generic drugs", she says.


Previously in HS International Edition:
  AstraZeneca board member says generic drug manufacturers take advantage of Finland (11.3.2004)
  Generic drugs bring savings of EUR 55.1 million (5.1.2004)
  Generic medicines save over EUR 5 million in April (22.5.2003)
  Generic medicines spark considerable price competition at pharmacies (15.4.2003)
  Finnish pharmacies running low on cheapest generic medicines (7.4.2003)
  Finnish pharmaceuticals industry could lose about 200 jobs (11.3.2003)

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