Key Benefits:
Law of 25 January 1996 laying down rules on the fixing of maximum prices for medicinal products
We Beatrix, at the grace of God, Queen of the Netherlands, Princess of Orange-Nassau, etc. etc. etc.
All of them, who will see or hear these, saluut! do know:
In this regard, we have taken into account that in order to promote public health it is desirable to ensure the availability of medicinal products at reasonable prices, that the prices of medicinal products should be borne by the Member States, to the extent that the the price of medicinal products, that the prices of medicinal products in the Netherlands are significantly higher than the prices of comparable medicinal products in other Member States of the Member States of the Community, European Union and therefore it is desirable to lay down rules which allow for the creation of a fixing maximum prices for medicinal products;
In this way, we, the Council of State, and with the mean consultations of the States-General, have been well-regarded and understood to be right and to be understood by the following:
1 The following shall be understood in this Act and the provisions which are based thereon:
a. Our Minister: Our Minister of Health, Welfare and Sport;
b. medicinal product: a medicine as intended in Article 1, first paragraph, point (b) of the Pharmaceutical Act For which a marketing authorisation or parallel trade permit has been granted under the conditions of the Pharmaceutical Act or under the Regulation, referred to in Article 1, first paragraph, point (fff) of that Act , or Regulation (EEC) No Decision No 2309/93 of the Council of the European Communities of 22 July 1993 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing Community procedures for the establishment of a A European Agency for the Evaluation of Medicinal Products (PbEG L 214);
c. similar medicine: a medicinal product having the same active ingredients, of the same or substantially the same strength and in the same pharmaceutical form as any other medicinal product;
d. maximum price: the maximum price for a medicinal product determined by Article 2 .
2 In the case of a general measure of management, pharmaceutical forms may be considered to be the same pharmaceutical form for the purposes of this Act.
1 In the case of a ministerial arrangement, a maximum price may be fixed for a medicinal product, the availability of which must be guaranteed by the public authorities in the opinion of Our Minister. The maximum price shall be expressed in an amount per amount to be given. On the preparation of the scheme is Section 3.4 of the General Administrative Law Act applicable. The design of the scheme shall be submitted to the two Chambers of the States-General at least four weeks prior to its adoption.
2 For the purpose of establishing a maximum price for a medicinal product, it is based on generally accepted price lists for Belgium, for the Federal Republic of Germany, for France and for the United Kingdom, by means of ministerial arrangements. country in the currency in question, the arithmetic mean of the prices of comparable medicinal products set out in those price lists for the provision to persons, including legal persons, who are empowered to do so provision of medicinal products to private users. Where prices are not included in a price list for the supply to private users of medicinal products, the prices shown shall be converted at prices corresponding to the corresponding prices. Application of the rules in force in that country. If the price of more than one pack size for a medicinal product is indicated, only the price of the package with the lowest price per unit of product shall be taken into account. Where appropriate, a price shall be fixed at a price for the quantity to be used in the scheme provided for in paragraph 1.
3 The average values fixed pursuant to paragraph 2 shall be converted into euro. This will be based on the exchange rate of the euro against the pound sterling as established by the European Bank on the date of issuance of the United Kingdom price schedule referred to in the second paragraph.
4 The maximum price shall be fixed at at least the arithmetic average of the amounts set out in the third paragraph in euro.
5 The fixing of a maximum price for a medicinal product does not take place if only one of the countries listed in the second paragraph for similar medicinal products is listed in the price lists provided for in paragraph 2.
6 For the purpose of fixing a maximum price, a price list shall be taken as a starting point, which has not been issued for more than six months before the date of fixing the maximum price.
7 In the case of a general measure of management, detailed rules may be laid down on the manner in which maximum prices are fixed.
1 At least twice a year Our Minister examines whether there is any reason to Article 2, first paragraph , amend the said scheme. If necessary, our Minister shall adapt the scheme within 90 days from the beginning of this investigation.
2 Furthermore, at the request of the person who offers the medicine for sale, our Minister may sell or deliver it to a person, including a legal person, who is responsible for the sale of the product. Pharmaceutical Act has the power to deliver medicinal products to private users, in special cases, the Article 2, first paragraph , to amend the scheme provided for in this Regulation. The last two full sentences of Article 2, first paragraph , do not apply to an amendment to the maximum price laid down in the ministerial arrangement under this paragraph.
3 The application for an amendment to the maximum price laid down shall state the reasons on which it is based.
4 If the information submitted in the submission of the application is inadequate, our Minister shall inform the applicant of any additional information required and shall give the applicant the additional information within one of the documents which he/she shall to provide time limit.
5 Our Minister shall decide within 90 days of receipt of the application or after receiving the additional information.
6 In the case of an exceptionally large number of applications, our Minister may, once the period referred to in paragraph 5, extend by 60 days. A decision to extend the period shall be made known to the applicant for the expiry of the period referred to in the fifth paragraph.
It is prohibited to offer a medicinal product at a price higher than the maximum price for sale, sale or sale by sale or by placing a price higher than the maximum price for a person, including a legal person understood, which is due to the Pharmaceutical Act has the power to deliver medicines to private users.
1 Any person who offers a medicinal product for sale, sells or provides for sale to a person, including a legal person, who is responsible for the sale of a medicinal product Pharmaceutical Act has the power to deliver medicinal products to private users, is obliged to conduct an administration, on a transaction-by-transaction basis, to whom and at which price he has sold the medicinal product concerned, and to the packaging size.
2 The records referred to in paragraph 1 shall be kept for a period of at least three calendar years following the year to which it relates. Where a fine has been imposed on a transaction to which the administration relates, the records shall be retained until the order for the imposition of the fine has become irrevocable.
1 With the supervision of compliance with or under this law, the officials appointed by the decision of Our Minister shall be responsible. Notice of a decision referred to in the first sentence shall be made by placing in the Official Gazette .
2 The supervisors do not have the powers, mentioned in the Articles 5:18 and 5:19 of the General Administrative Law Act .
Our Minister may impose an administrative fine of up to € 45 000 on the subject of infringement of Article 4 or 5 .
Our Minister shall send within eighteen months of the first time after a settlement as referred to in Article 2, first paragraph , it has been established, to the States General a report on the effectiveness and effects of this law in practice.
This Law shall enter into force on a date to be determined by Royal Decree. It shall expire on the first day of the fifth calendar year following that in which it was last subject to the following rules: Article 2, first paragraph -That's right.
This law is cited as: drug prices law.
Burdens and orders that are in the State Sheet will be placed, and that all ministries, authorities, colleges and officials who so concern will keep their hands on the precise execution.
Issued in Gravenhage, 25 January 1996
Beatrix
The Minister for Health, Welfare and Sport,
E. Borst-Eilers
Issued on 15 February 1996The Minister of Justice,
W. Sorgdrager
