Summary

Icelandic Medicines Agency (2007-)

Icelandic Medicinal Control Agency (2000-2006 )

The Icelandic Medicinal Control Agency, falling under the Ministry of Health, came from the merger of the Icelandic Medicines Control Agency and State Drug Inspectorate in 2000. The merged agency formally opened on 1 November 2000. There are now 34 employees at the Icelandic Medicinal Control Agency, in addition to numerous advisors, principally in the fields of medicine and pharmacology. The agency has three main divisions: Registration, Monitoring and Administration. The divisions reflect the main activities of the former Icelandic Medicines Control Agency and State Drug Inspectorate. Medicinal product control agencies in the European Economic Area collaborate broadly on pharmacological affairs, and the main forum for this collaboration is the European Agency for the Evaluation of Medicinal Products (EMEA), with its headquarters in London. In addition, agreements have been entered into with countries outside the European Economic Area, such as Canada, on mutual recognition of pharmacological monitoring, manufacture of medicinal products, distribution of such products, etc.

Icelandic Medicines Control Agency (1963-2000)

The Icelandic Medicines Control Agency was originally small but grew quickly because of constant changes, in both Iceland and Europe, in medicinal products legislation. In a historical context, provisions of the Medicinal Products Sales Act of 1963 (No. 30/1963) stipulated that a Medicinal Product Registration Committee should consist of six members appointed for a term of six years to make proposals on a medicinal products register, prescription files and medicinal product formulas. The committee members appointed were specialists in the field of pharmacology and medicine. The legislative history of the 1963 act explained the reason for establishing the Medicinal Product Registration Committee: its functions included being an observer in the Nordic Medicinal Product Registration Committee and making proposals on the registration of proprietary medicinal products in Iceland. (Althingi Register A. 1962, Parliamentary document 54, p. 261-2) At this time, there were two committees operating in the Nordic countries, i.e., the Medicinal Product Registration Committee, a cooperative Nordic committee, with the function of putting together Pharmacopoea Nordica (the Nordic medicinal products register), and then the Medicinal Products Committee in each country that made proposals on the registration of proprietary medicinal products. The model for the Icelandic committee's activities can therefore be traced to the Nordic countries. Previously in Iceland the main task of medicinal products registration committees was to approve standards for the manufacture of medicinal products since most medicinal products were then produced in pharmacies. This has changed, and now there are almost only proprietary medicinal products on the market, manufactured in pharmaceutical factories. The committees also had the function of advising on the drafting of regulations regarding pharmacological matters.

In 1978 a new Act on Medicinal Products was passed (Act No. 49/1978). Chapter VIII of the act details a medicinal products committee that shall consist of three members; later, representatives of pharmacists and pharmacologists, a doctor and the Chief Veterinary Officer took seats on the committee, depending on the issue area being addressed. The committee's function was to make proposals on the following matters: a regulation defining the concept of medicinal products, production formulas for standardized, prescription medicinal products, registration and deregistration of medicinal products, classification of medicinal products, ban on the sale and import of medicinal products, a regulation on the labelling of medicinal products, advertising of medicinal products sold without prescription, issuance of licenses for experimental and unregistered medicinal products, various other matters regarding implementation of the act, including cooperation with foreign committees for medicinal product registration. The committee's tasks also included deciding a medicinal products standard, advising the Icelandic Medicines Control Agency on the legality of advertisements and advising the Directorate of Health on the drafting of notices and information about medicinal products, preparing the registration of the side effects of medicinal products in Iceland and providing information to doctors in this regard.

The committee, which was housed in the Ministry of Welfare, made proposals to the minister regarding pharmacological matters. The committee was not a proper governmental entity at a lower administrative level but a committee within the ministry, bearing the name "Medicinal Products Committee". On the other hand, the enactment of the Medicinal Products Act of 1994 changed the committee's basis in important respects when it attained independent administrative status and the name "Icelandic Medicines Control Agency". Decisions regarding pharmacological matters (issue of market licenses, etc.) were therefore moved to a lower governmental entity, as is common with specialized issue categories.

The new Medicinal Products Act, No. 93/1994, stipulated that the Icelandic Medicinal Products Committee would be under the supervision of the Minister of Health and Social Security and should consist of five members with expertise in the fields of medicine and pharmacology, along with two veterinarians. The founding of the Icelandic Medicinal Control Agency, with the passage of Act No. 108/2000, transferred the activities of the Icelandic Medicinal Products Committee to the new agency, which exercises proper administrative authority regarding pharmacological affairs under the supervision of the Ministry of Welfare. A special Medicinal Products Committee of the Icelandic Medicinal Control Agency is now the agency's advisory committee regarding pharmacological matters. As previously, the committee members shall have expertise in the broadest possible fields of medicine and pharmacology.

Icelandic Medicines Control Agency (1963-2000)

The first mentions in law of medicinal product monitoring were in a directive, dated 4 December 1672, on medical doctors and pharmacists and 128 years later in a letter of decree from the Royal Danish Ministry Office, dated 16 September 1797, on medicinal product sales. The provisions of Act No. 69/1928 deal with the monitoring of pharmacies. The first comprehensive legislation in this field, on the other hand, is the Medicinal Products Sales Act, passed by Althingi in 1963.

There was some prelude to this first legislation, for a committee was first appointed in 1942 to prepare comprehensive legislation in the field of pharmacological matters. Thus, on 15 January 1944 the committee, which was appointed with five members by the Minister of Health on 26 August 1942, sent the Government a parliamentary bill for a Medicinal Products Sales Act that the committee had drafted. This parliamentary bill was never presented to Althingi in its original form.[1] With a letter, dated 6 December 1945, the then Minister of Health, Finnur Jónsson, sent the parliamentary bill, which had been sent to the Government on 15 January 1944, somewhat changed to the Althingi's Committee on Health and Social Affairs, requesting the committee to introduce it in Althingi. However, this never happened. (Althingi Register A. 1962, Parliamentary document 54, p. 260)

On the other hand, the parliamentary bill was presented in Althingi in 1949, somewhat amended and revised, but was not passed. By way of information, below are the fundamental points that the committee agreed on in drafting this new legislation: (Althingi Register A. 1949, Parliamentary document 357, p. 529-530)

  1. The following must generally be required of commerce in medicinal products:
    1. As good and as carefully prepared medicinal products and pharmaceutical goods as possible
    2. Always a sufficient inventory of all necessary drugs and medicinal products
    3. Fast and orderly service along with assurance against any kind of accidents and misconduct
    4. The lowest possible product prices without relaxing the requirements set out above
  2. If medicinal product commerce in Iceland is to be capable of satisfying the above requirements, there is need for thoroughgoing reforms in its current organization.
  3. Medicinal product commerce is the form of commerce least suited to being run according to the tenets of unrestricted free business competition.
  4. Commerce in medicinal products, on the contrary, will be subject to extensive government intervention and constraint and ever-vigilant monitoring by specialist representatives of the general public.
  5. Expert, selected and knowledgeable people, both managers and other employees, must conduct medicinal product commerce.
  6. Medicinal products are the essential products least suited to be a tax base.
  7. It is even more absurd that medicinal product commerce can be the basis of highly profitable companies owned by individuals.
  8. The work in medicinal product commerce must be assured so respectable a status in the public's consciousness and its employees ensured terms and prospects of merit, that jobs in medicinal product commerce will be no less desirable to intelligent, promising people than other comparable positions of responsibility in society.
  9. Changes in the organization of commerce in medicinal products must garner the support of so large a part of the pharmaceutical profession that there need be no fear of its opposition to the new organization, which could derail it completely, even before it could be tested.
  10. Completely state-operated commerce in medicinal products would have various defects that undeniably reduce the value of many state-operated companies, such as: insufficient interest of managers and employees and thereby a risk of stagnation, selection of employees according to criteria other than professional merit, unnecessarily many employees and other neglect in operational savings, business inflexibility, etc. Even though few or even none of these points applied, there would be a risk of constant suspicion of such defects with a state-operated company, and this, by itself, would be a substantial defect in medicinal product commerce, which so requires the highest trust of the general public.

The parliamentary bill was then reintroduced in Althingi 1950-1951, with few changes. The parliamentary bill did not pass that time, either. In 1958 a parliamentary bill was sent to Althingi to be introduced, but was not introduced in that legislative session (No. 78). (Althingi Register A. 1962. Parliamentary document 54, p. 260)

The parliamentary bill finally managed to pass in 1963, with several amendments, and became the Medicinal Products Sales Act, No. 30/1963.

The Medicinal Products Sales Act, No. 30/1963, dealt with the monitoring, at least once a year, of pharmacies, the preparation of medicinal products and medicinal product wholesalers and other medicinal product commerce according to circumstances, in consultation with the Directorate of Health. To implement monitoring of these parties and see to other aspects of monitoring in accordance with the act or other government directives, a medicinal product inspector, who would hold a degree in pharmacology, should work in the Ministry of Welfare. Then, there shall be specialized assistants helping him with the monitoring, as needed. Directions concerning the work of monitoring and its arrangement shall be provided in a regulation. This regulation, on the other hand, did not see the light of day until 1973. The appointment of a special inspector was not stipulated in the Medicinal Products Sales Act of 1963 but rather in Act No. 60 of 1957 on the University of Iceland. (Althingi Register A. 1962, Parliamentary document 54, p. 268)

The Medicinal Products Sales Act of 1963 also made stipulations regarding the monitoring of proprietary medicinal products. The provisions of Article 61 of the Medicinal Products Sales stated that the minister, after receiving proposals from the Directorate of Health, would issue a regulation on the monitoring of proprietary medicinal products. Companies manufacturing or building on proprietary medicinal products in Iceland were therefore subject to inspection in accordance with provisions that the minister set by regulation. For example, the regulation could require a declaration of honour that the conditions for registration of a proprietary medicinal product had been fulfilled. It can be said that since then requirements have increased noticeably, and declarations of honour would not now be deemed satisfactory. Article 61 of the Medicinal Products Sales Act also stipulated that when technical secrets were involved, the party divulging them could request of the Directorate of Health that the information not reach representatives of pharmacologists and pharmacists on the Medicinal Product Registration Committee. The Directorate of Health, on the other hand, could decide to what extent these requests would be granted; part of the proprietary medicinal products used in Iceland will be manufactured abroad, and only those proprietary medicinal products. Regarding the provisions of Article 61 of the Medicinal Products Sales Act, the legislative history states: "It is probable that most of the proprietary medicinal products that will be used in Iceland will be manufactured abroad, and only the proprietary medicinal products manufactured by certified pharmaceutical factories in countries where there is strict monitoring of the manufacture of the medicinal products will be registered. Nevertheless, Iceland, like other countries, requires vigilant monitoring of the proprietary medicinal products used in the country, both foreign and domestic, and the provisions of Article 61 are aimed at such monitoring being as secure as possible, among other things, by obligating the manufacturers of proprietary medicinal products to provide necessary information regarding testing of the medicinal products." (Althingi Register A. 1962, Parliamentary document 54, p. 268-270)

It can be said that this was one of the first indicators of the medicinal product monitoring that we know today and later became the Icelandic Medicines Control Agency until the Icelandic Medicinal Control Agency formally began operating in 2000. Regulation No. 412/1973 applied to the Icelandic Medicines Control Agency, which, on the other hand, was set in accordance with the Medicinal Products Sales Act, No. 30/1963. Act No. 78/1982 on medicinal product distribution later replaced the Medicinal Product Sales Act of 1963. The main mission of the Icelandic Medicines Control Agency, according to the Medicinal Products Sales Act of 1978 is as follows:

  1. To see to the scientific monitoring of the operations of pharmacies and pharmaceutical wholesalers, medicinal product preparation and other companies and institutions selling, manufacturing, importing or making medicinal products.
  2. To monitor the medicinal product inventories of hospital departments and other comparable institutions.
  3. To monitor the import of medicinal products and medicinal product raw materials for the preparation of medicinal products.
  4. To evaluate the purchase prices of medicinal products and make recommendations to the minister on approval of them, cf. the provisions of Article 34, paragraph 5.
  5. To see to the monitoring of the price of medicinal products at wholesale and retail.
  6. To monitor advertisements of medicinal products and see to it that the presentation and distribution of medicinal products is generally in accordance with current law and regulations, cf. Articles 18-26.

The monitoring of other companies or products other than medicinal products may also be entrusted to the Icelandic Medicines Control Agency if there are special reasons to do so.

The mission of the Icelandic Medicines Control Agency stipulated in the Medicinal Product Sales Act of 1978 is by and large the same as its mission has been in medicinal product legislation ever since and is today under the Icelandic Medicinal Control Agency.