Table 4. Sweden rulings of breach of selected clauses 2004–2012.
| § | Description | Abbreviated Specification | All Breaches n = 972 a | All Cases n = 536 b | Serious Cases n = 101 c |
|---|---|---|---|---|---|
| 2 | Marketing authorization | The SPC constitutes the factual basis for information. Information may only refer to drugs that have received marketing approval. | 156 (16%) | 156 (29%) | 50 (49%) |
| 4 | Information, claims, and comparisons | Information must be truthful and may not contain any presentation that directly or indirectly is intended to mislead. E.g., exaggerated claims about properties or effects may not be made (§4.3). | 250 (26%) | 250 (47%) | 67 (66%) |
| 8 | Documentation and references | Information as to the quality and efficacy of a drug shall be capable of substantiation by means of documentation of a high scientific standard. | 14 (1.4%) | 14 (2.6%) | 4 (4.0%) |
| 10 | Documentation and references | Information that contains quotations, data, etc., from a scientific study or deals with a comparison between drugs based on such a study, must clearly contain information about relevant sources and references. | 18 (1.9%) | 18 (3.4%) | 4 (4.0%) |
| 11 | Documentation and references | E.g., a study may not be cited in such a way that it could convey an incorrect or misleading impression of its nature, scope, implementation, or importance (§11.2); Statements of comparisons should be expressed in such a way as to make clearly evident their statistical validity (§11.4). | 62 (6.4%) | 62 (12%) | 22 (22%) |
| 12 | Comparisons | Comparisons between effects, active ingredients, costs of treatment, etc., must be presented in such a way that the comparison as a whole is fair. | 64 (6.6%) | 64 (12%) | 22 (22%) |
| 102 | Marketing to the public: marketing authorization | Information to the public on prescription drugs shall be supplied only to the extent permitted in the MPA’s provisions and that which applies according to laws and regulations. Information shall be consistent with the SPC: see §2. | 100 (10%) | 100 (19%) | 18 (18%) |
| 104 | Marketing to the public: information, claims, comparisons | Information or claim must be truthful and may not contain any presentation in words or pictures that directly or indirectly is intended to mislead. See §4. | 73 (7.5%) | 73 (14%) | 14 (14%) |
| 32–42 | Agreement on relations with health care sector | E.g., rules on provision of items, goods, services, sponsorship, and hospitality; Sponsorship of activities/conferences within the operations of the public health care or pharmacy companies may not take place (§38); No gifts or financial benefits may be supplied, offered, or promised to personnel/pharmacy as an incentive to recommend, prescribe, purchase, supply, sell, or administer drugs (§40). | 54 (5.6%) | 54 (10%) | 0 |
aPercentages indicate cell portion of total breaches. E.g., 16% of breaches pertained to §2.
bPercentages indicate cell portion of total cases. E.g., 29% of cases involved one or more §2 ruling.
cPercentages indicate cell portion of total serious violation cases. E.g., 49% of serious violation cases involved one or more §2 ruling.