The amendment aims at alleviating the existing regime for
pricing of pharmaceuticals for home treatment of chronic, genetic
and/or rare diseases and paid by the National Health Insurance Fund
(NHIF). It affects the interests of individuals
with health insurance and the activities of more than 290
authorisation holders, of the wholesalers of pharmaceuticals, and
of pharmacies (as retailers).
The discussed amendment to the Bulgarian Ordinance on the terms
and conditions for registration and regulation of
pharmaceuticals' prices (the
"Ordinance"), was published on
January 2, 2017. It restores the legal situation that existed
before September 2016, repealing the provisions of art.5,
para.5 of the Ordinance. The abolished provision provided that the
medicinal products included in the national positive list could not
be subject to an additional patient side payment exceeding
60 % of the price calculated on the basis of the reference
price of the medicinal product with the lowest price for a defined
daily dosage/ therapeutic course.
This limitation of the additional payment of patients was
introduced in September 2016. The government's reasoning was
that it would have social benefits only. However, the impact
assessment showed that the application of this provision may:
lead to a withdrawal from the local
market of a large number of pharmaceuticals that are unable to meet
the required limitation; and
create burdens for wholesalers and
retailers as they will have to keep statistical records of all
products with the lowest prices.
The limitation was challenged before the Supreme Administrative
Court, with the argument that it creates inter alia a
precondition for price fixing. The case is still pending. The
discussed repeal from the government (the Ordinance is a secondary
legislation), overtook the final judgment in this case.
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