Icelandic Medicines Agency (2000-)

The Icelandic Medicines Agency operates under the Ministry of Health and was established through the merger of the State Medicines Board and the State Pharmaceutical Inspectorate in 2000. The merged agency formally began operations on 1 November 2000.

The Agency is divided into two main divisions: Medicinal Product Assessment and Registration, and Access and Safety. Its support functions include executive management and Finance and Infrastructure. Finance and Infrastructure covers information technology, the service desk, administration and legal affairs, records management, and finance. The Agency’s employees are educated in pharmacy, pharmaceutical chemistry, pharmaceutical technology and medicine, as well as other specialist fields.

International cooperation

Medicines agencies in the European Economic Area cooperate extensively in the field of medicinal products, and the European Medicines Agency (EMA), based in Amsterdam, is the main forum for this cooperation. In addition, agreements have been concluded with countries outside the European Economic Area, such as Canada, on mutual recognition in the fields of pharmaceutical inspection, medicinal product manufacture, distribution of medicinal products and related areas.

State Medicines Committee (1963–2000)

The State Medicines Board was initially a small institution that grew rapidly due to continual changes in medicinal products legislation, both in Iceland and in Europe.

In historical terms, the provisions of the Pharmacy Act from 1963, No. 30/1963, stipulated that a so-called Pharmacopoeia Committee should be appointed, consisting of six members appointed for six years at a time, to make proposals concerning the pharmacopoeia, prescription formularies and pharmaceutical formulae. The committee members were specialists in the fields of pharmacy and medicine. The explanatory notes to the 1963 Act explained the reason for establishing the Pharmacopoeia Committee, whose role included acting as an observer in the Nordic Pharmacopoeia Committee and making proposals on the registration of proprietary medicinal products in Iceland (Alþt. A. 1962, parliamentary document 54, pp. 261–262).

At that time, two committees in the field of medicinal products were active in the Nordic countries: the Pharmacopoeia Committee, a joint Nordic committee responsible for preparing the Nordic Pharmacopoeia, Pharmacopoea Nordica, and a medicines committee in each country that made proposals on the registration of proprietary medicinal products. The model for the committee’s activities can therefore be traced to the Nordic countries.

Previously, the main task of pharmacopoeia committees was to approve standards for the manufacture of medicinal products, as most medicinal products at that time were manufactured in pharmacies. This has changed, and the market now consists almost exclusively of proprietary medicinal products manufactured in pharmaceutical factories. The committees also had the role of advising the ministry on the drafting of regulations on medicinal products.

Development of the role and legal status

In 1978, a new Medicinal Products Act was adopted, Act No. 49/1978. Chapter VIII of the Act describes a medicines committee to be composed of three members. Representatives of pharmacists and pharmacy owners, a physician and the Chief Veterinary Officer, together with a veterinarian depending on the matter under discussion, subsequently sat on the committee.

The committee’s role was to make proposals on the following matters:

• Regulations on the definition of the term medicinal product

• Manufacturing formulae for standard formula medicinal products

• Registration and deregistration of medicinal products

• Classification of medicinal products

• Prohibition of the sale and importation of medicinal products

• Regulations on the labelling of medicinal products

• Advertising of non-prescription medicinal products

• Granting of authorisations for trials involving unregistered medicinal products

• Various other matters relating to the implementation of the Act, including cooperation with foreign pharmacopoeia committees

Furthermore, the committee’s tasks included determining the pharmaceutical standard, advising the State Pharmaceutical Inspectorate on the validity of advertisements, advising the Director of Health on the preparation of notices or information on medicinal products, working on the registration of side effects, or adverse reactions, to medicinal products in Iceland, and providing related information to physicians.

The committee, which was based in the Ministry of Health and Social Security, made proposals to the minister on matters relating to medicinal products. It was not an actual lower-level administrative authority, but rather a committee within the ministry called the “Medicines Committee”. With the Medicinal Products Act of 1994, however, the basis of the committee changed in important respects when it was granted an independent administrative status and given the name “State Medicines Board”, under the overall authority of the Minister of Health and Social Security. Decisions on medicinal products matters, including the granting of marketing authorisations, were therefore transferred to a lower-level administrative authority, as is common in specialised fields.

Under the new Medicinal Products Act No. 93 of 1994, it was provided that the State Medicines Board would be subject to the overall authority of the Minister of Health and Social Security and would consist of five members with specialist expertise in the fields of medicine and pharmacy, together with two veterinarians. With the establishment of the Icelandic Medicines Agency under Act No. 108/2000, the activities of the State Medicines Board were transferred to the new Agency, which exercises actual administrative authority in the field of medicinal products under the overall authority of the Ministry of Health and Social Security. The special Medicines Committee of the Icelandic Medicines Agency is now the Agency’s advisory committee on medicinal products. As before, it is to be composed of persons with specialist expertise in the broadest possible range of fields within medicine and pharmacy.

State Pharmaceutical Inspectorate ( 1963-2000)

The first legislation on pharmaceutical inspection

Pharmaceutical inspection was first addressed in legislation in the Ordinance of 4 December 1672 on physicians and pharmacists, and 128 years later in the Chancellery Letter of 16 September 1800 on the sale of medicinal products. The provisions of Act No. 69/1928 then addressed supervision of pharmacies. However, the first comprehensive legislation in this field was the Pharmacy Act, adopted by Althingi in 1963.

The preparation of the first pharmaceutical legislation had a considerable history. In 1942, a committee was first appointed to prepare comprehensive legislation in the field of medicinal products. On 15 January 1944, the committee, composed of five members appointed by the Minister of Health on 26 August 1942, submitted to the government a bill on the sale of medicinal products which it had drafted. This bill was never submitted to Althingi in its original form.

By letter dated 6 December 1945, the then Minister of Health, Finnur Jónsson, sent the bill that had been submitted to the government on 15 January 1944, with certain amendments, to the Health and Social Affairs Committee of the Lower House of Althingi, requesting that the committee submit it to Althingi. This does not appear to have happened. (Alþt. A. 1962, parliamentary document 54, p. 260).

The bill was, however, submitted to Althingi in 1949 in a somewhat amended and revised form, but was not passed. For reference, the following are the fundamental principles agreed upon by the committee when drafting this new pharmaceutical legislation: (Alþt. A. 1949, parliamentary document 357, pp. 529–530).

General pharmaceutical trade should be required to provide:

• Medicinal products and pharmaceutical goods of the highest possible quality.

• Adequate supplies at all times of all necessary medicinal products and medical supplies.

• Prompt and orderly service, together with safeguards against all kinds of accidents and misconduct.

• The lowest possible product prices, without compromising the requirements stated above.

If pharmaceutical trade in Iceland is to be able to meet the above requirements, fundamental improvements to its current organisation are needed.

• Pharmaceutical trade is among the least suitable forms of trade to be operated according to the unrestricted laws of free commercial competition.

• On the contrary, pharmaceutical trade must be subject to extensive public intervention and control, as well as continuous supervision by knowledgeable representatives trusted by the public.

• Pharmaceutical trade must be carried out by knowledgeable and selected professionals, both managers and other employees.

• Medicinal products are among the least suitable necessities to serve as a source of taxation.

• It is even more unreasonable for pharmaceutical trade to become a highly profitable enterprise for private individuals.

• Work in pharmaceutical trade must be given such a respected position in public consciousness, and those working in it must be given such conditions and prospects for advancement, as they deserve, so that pharmaceutical work becomes no less attractive to intelligent men of means than other comparable positions of trust in society

• Organisational changes to pharmaceutical trade must receive the support of such a large part of the pharmaceutical profession that there need be no fear of organised opposition to the new arrangement, as such opposition could undermine it completely, even before it had the opportunity to prove itself.

• Full state monopoly in medicinal products would involve various drawbacks which undeniably reduce the value of too many state-run enterprises, such as insufficient interest on the part of managers and employees, and the resulting risk of stagnation; selection of employees on grounds other than the relevant merits; unnecessarily high staffing levels and other lack of attention to economy in operations; inflexibility in business dealings, etc.

Even if few or none of these problems arose, there would be a risk of constant suspicion of such defects in a state enterprise, which in itself would be a considerable drawback for pharmaceutical trade, where it is of such importance that the public have full confidence.

This bill was subsequently reintroduced in Althingi in 1950–1951, with minor amendments. The bill was again not passed. In 1958, the bill was once more sent to Althingi for submission, but was not submitted during that parliamentary session, the 78th session. (Alþt. A. 1962, parliamentary document 54, p. 260.)

The bill was finally adopted in 1963 with certain amendments and became the Pharmacy Act No. 30/1963.

State pharmaceutical inspection was based in the Ministry of Health and Social Security. Article 47 of the Pharmacy Act No. 30/1963 addressed inspection of pharmacies, pharmaceutical manufacturers and pharmaceutical wholesalers at least once a year, and of other pharmaceutical businesses as circumstances required, in consultation with the Director of Health. To supervise these parties and perform other inspection duties under the Act or other administrative provisions, a pharmaceutical inspector, educated as a pharmacist, was to work within the Ministry of Health and Social Security. Specialised support staff were also to assist with inspection as needed. The duties and working methods of the inspection were to be set out in a regulation. That regulation, however, was not issued until 1973. The appointment of a special inspector was not provided for in the Pharmacy Act of 1963, but in Act No. 60 of 1957 on the University of Iceland. (Alþt. A. 1962, parliamentary document 54, p. 268).

The Pharmacy Act of 1963 also provided for so-called supervision of proprietary medicinal products. Article 61 of the Pharmacy Act stated that the minister was to issue, by regulation, provisions on the supervision of proprietary medicinal products, following proposals from the Director of Health. Companies that manufactured or packaged proprietary medicinal products in Iceland were therefore subject to supervision under provisions laid down by the minister in a regulation. The regulation could, among other things, require a declaration of honour stating that the conditions for registration of a proprietary medicinal product had been met.

It can be said that requirements have increased considerably since that time, and declarations of honour would no longer be considered sufficient. Article 61 of the Pharmacy Act also specifically provided that, where technical secrets were involved, the party disclosing them could request that the Director of Health ensure that the information not be passed on to the representatives of pharmacists and pharmacy owners on the Pharmacopoeia Committee. The Director of Health could, however, decide the extent to which such requests would be granted.

Regarding Article 61 of the Pharmacy Act, the explanatory notes state:

“Most of the proprietary medicinal products used in Iceland are likely to be manufactured abroad, and only those proprietary medicinal products manufactured by recognised pharmaceutical factories in countries where strict supervision of pharmaceutical manufacture is in place will be registered. Nevertheless, Icelanders, like other nations, must maintain active supervision of the proprietary medicinal products used here, both foreign and domestic. Article 61 is intended to ensure that such supervision can be as reliable as possible, including by requiring manufacturers of proprietary medicinal products to provide necessary information concerning studies of the medicinal products.” (Alþt. A. 1962, parliamentary document 54, pp. 268–270)

It can be said that this was one of the first indications of the pharmaceutical inspection system we know today, which later became the State Pharmaceutical Inspectorate and remained so until the Icelandic Medicines Agency formally began operations in 2000.

The State Pharmaceutical Inspectorate becomes an independent institution

The State Pharmaceutical Inspectorate was formally established by the Medicinal Products Act No. 49/1978. The Act defined the role of the State Pharmaceutical Inspectorate as an independent institution. Regulation No. 412/1973 applied to the State Pharmaceutical Inspectorate, although it had been issued under the Pharmacy Act No. 30/1963. Act No. 78/1982 on the distribution of medicinal products later replaced the Pharmacy Act of 1963.

The main functions of the State Pharmaceutical Inspectorate under the Medicinal Products Act of 1978 were as follows:

• To carry out professional supervision of the operation of pharmacies, pharmaceutical wholesalers, pharmaceutical manufacturers and other companies and institutions that sell, manufacture, import or package medicinal products.

• To supervise stocks of medicinal products in hospital departments and other comparable institutions.

• To supervise the importation of medicinal products, active substances and raw materials for the manufacture of medicinal products.

• To assess the purchase price of medicinal products and make proposals to the minister regarding its approval, cf. also the provisions of Article 34, paragraph 5.

• To supervise the wholesale and retail prices of medicinal products.

• To supervise advertising of medicinal products and ensure that the promotion and distribution of medicinal products are generally in accordance with applicable laws and regulations, cf. Articles 18–26.

• The pharmaceutical inspectorate could also be entrusted with supervision of other companies or products other than medicinal products where special reasons so warranted.

The role of the State Pharmaceutical Inspectorate as set out in the Medicinal Products Act of 1978 is, in broad terms, the same as the role it has had in pharmaceutical legislation ever since and still has today, although it now falls under the Icelandic Medicines Agency.