Act No. 76 / 2011 Coll.
Law on the temporary reduction of prices and reimbursement of medicines
Valid
Effective from 01.04.2011
76
THE LAW
of 3 March 2011
on the temporary reduction of prices and reimbursement of medicines
Parliament has decided on this law of the Czech Republic:
AMENDMENT OF THE PRICE AND REIMBURSEMENT OF THE SELECTED GROUP IV
On the date of entry into force of this Act, the basic remuneration of the reference group as laid down in the last administrative procedure for determining or amending the amount and conditions for payment of any medicinal product or food for special medical purposes in the reference group under Act No. 48 / 1997 Coll., on public health insurance and on the amendment and addition of certain related laws, as amended and amended by the State Institute for Drug Control, shall be reduced by 7% until the first revision of the remuneration of the reference group under Act No. 48 / 1997 Coll., on public health insurance and amending and related laws, as effective as from 1.1.2008 (hereinafter referred to as "the first revision '), but no later than 1 year after the date of the entry into force of this Act.
(1) By the date of entry into force of this Act, the applicable maximum prices and the level of reimbursement of all medicinal products and foodstuffs for special medical purposes are reduced by 7% until the first revision is carried out, but for a maximum period of 1 year from the date of entry into force of this Act. This does not apply to the remuneration of medicinal products and food for special medical purposes, which has been determined by the amount and conditions of payment pursuant to § 39b to 39h of Act No. 48 / 1997 Coll., on public health insurance and on the modification and addition of certain related laws, as effective from 1.1.2008, or for which a change in the amount and conditions of payment have been made pursuant to § 39i (2) or § 39l of Act No. 48 / 1997 Coll., on public health insurance and on the modification and addition of certain related laws, as effective from 1.1.2008.
(2) The request for an increase in the maximum price under Act No. 48 / 1997 Coll., on Public Health Insurance and to amend and supplement certain related laws, as effective from the effective date of the Act, cannot be made in the period from the date of entry into force of the Act until the first revision, but no longer than 1 year from the date of entry into force of the Act.
On the date of the entry into force of this Act, the reported highest prices of medicinal products and foodstuffs for special medical purposes covered by public health insurance under Act No 48 / 1997 Coll., on public health insurance and on the amendment and addition of certain related laws, as effective before the entry into force of this Act, which are not subject to the price regulation of the producer's price, shall be reduced by 7% until the first revision, but for a maximum period of 1 year from the date of entry into force of this Act, while holders of marketing authorisations for authorised medicinal products and domestic manufacturers or importers of non-authorised medicinal products or foodstuffs for special medical purposes may trade at a maximum of those reduced prices during that period.
At the date of entry into force of this Act, the State Institute for Drug Control will publish the prices and amounts of the remuneration provided for in Sections 2 and 3 in the List of Medicinal Products and Food for Special Medical Purposes covered by health insurance.
(1) In exceptional cases, marketing authorisation holders for authorised medicinal products or domestic manufacturers or importers of non-authorised medicinal products or food for special medical purposes may request a derogation from the price reduction provided for in Sections 2 and 3 from the State Institute for Drug Control.
(2) In the proceedings for a request for an exemption from the price reduction of the State Institute for Drug Control, the Administrative Order, as effective from the date of entry into force of this Act, shall be applied in accordance with Act No. 500 / 2004 Coll., the Administrative Code, which shall only be permitted to grant an exemption if:
(a) the price of a medicinal product or food for special medical purposes reduced in accordance with Sections 2 and 3 is the lowest of the prices of such medicinal product or food for special medical purposes established in the Member States of the European Union under Section 39c of Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as effective from the date of entry into force of this Act;
(b) a medicinal product or food for special medical purposes is necessary to ensure the availability of effective and safe health care covered by public health insurance under Act No. 48 / 1997 Coll., on Public Health Insurance and amending and supplementing certain related laws, as effective from the date of entry into force of this Act; and
(c) the medicinal product or food for special medical purposes cannot be reasonably required to be made available on the Czech market at a reduced price.
(3) The exemptions granted by the State Institute for Drug Control are published without delay in the List of Medicinal Products and Food for Special Medical Purposes covered by public health insurance.
For the purposes of this Act, the reference group shall always mean a medicinal product or food for special medical purposes, or a group of medicinal products or food for special medical purposes, in principle interchangeable therapeutically with similar or close efficacy, safety and similar clinical use, which cannot be included in a reference group under Decree No 384 / 2007 Coll., on the list of reference groups, as effective from the date of entry into force of this Act.
EFFECTIVE
That law shall take effect on the first day of the calendar month following its publication.
Germany
Klaus v. r.
Nausea v. r.
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Regulation Information
| Citation | Act No. 76 / 2011 Coll., on Temporary Reduction of Prices and Reimbursement of Drugs |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 25.03.2011 |
|---|---|
| Effective from | 01.04.2011 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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