Source: https://www.prolekarniky.cz/casopisy/plos-medicine/2015-2/complaints-complainants-and-rulings-regarding-drug-promotion-in-the-united-kingdom-and-sweden-2004-2012-a-quantitative-and-qualitative-study-of-pharmaceutical-industry-self-regulation-53023
Timestamp: 2020-08-09 13:52:25
Document Index: 286865716

Matched Legal Cases: ['§2', '§4', '§104', '§8', '§10', '§12', '§2', '§102', '§102', '§32', '§42', '§2', '§2', '§2', '§2', '§2']

Complaints, Complainants, and Rulings Regarding Drug Promotion in the United Kingdom and Sweden 2004–2012: A Quantitative and Qualitative Study of Pharmaceutical Industry Self-Regulation | proLékárníky.cz
Published in the journal: . PLoS Med 12(2): e32767. doi:10.1371/journal.pmed.1001785
doi: 10.1371/journal.pmed.1001785
A string of whistleblower cases in the United States over the past decade has spotlighted the illicit marketing practices of pharmaceutical companies [1,2]. However, in stark contrast to the US, Europe has had few high-profile cases [3]. This invites the question whether illicit marketing is uncommon in Europe, or whether other factors may account for this disparity, such as lack of monetary incentives for whistleblowers, or other aspects of the European legal and regulatory framework. Indeed, it has been suggested that industry may refrain from illicit marketing in Europe because in many countries industry is highly involved in policing marketing claims, which is purported to provide the industry with incentive to comply with rules [4,5]. Thus, in many European countries promotion is governed by a voluntary code of practice administered by the industry’s own system of self-regulation [5–8]. Such an arrangement differs from the US—and some European countries, e.g., France [5]—where regulatory agencies such as the Food and Drug Administration (FDA) directly regulate promotion [9].
Fig. 1. Self-regulatory schemes in the United Kingdom and Sweden.
Both countries have a dual-structure self-regulatory system. Complaints emerge from either industry or non-industry sources. In the former case, companies must first attempt to settle disagreements through inter-company dialogue. The Code of Practice (CP) Panel in the UK (A) and the IGM in Sweden (B) impose economic sanctions on violating companies and also publicize rulings. In addition, the IGM may require a company to issue a corrective statement. The CP Appeal Board and the NBL deal with appeals. The CP Panel can also report any company to the CP Appeal Board whose conduct under the Code is of special concern. The CP Appeal Board has a greater range of non-economic disciplinary measures at its disposal than does the NBL. The respective industry trade group may discipline companies in extreme cases (not shown). NGOs, non-governmental organizations.
In Sweden, since 1974 two self-regulatory bodies supervise company adherence to the code: the Pharmaceutical Industry’s Information Examiner (IGM) and the Information Practices Committee (NBL). The IGM is appointed to deal with complaints, a role analogous to the UK Code of Practice Panel. However, unlike the Code of Practice Panel, the IGM does not address complaints from public authorities such as the Swedish Medical Products Agency (MPA, the national medicines regulatory authority). Instead, such complaints are sent directly to the NBL committee, which, except in this respect, is functionally analogous to the UK Code of Practice Appeal Board; its main role is to address appeals of IGM decisions.
Tab. 1. Information from self-regulatory bodies in the UK and Sweden.
Tab. 2. Constitution and procedures of self-regulation in the UK and Sweden.
The Swedish IGM is a scientifically qualified physician. As of 2013, two IGMs may be appointed by the LIF: one responsible for activities and material geared toward health professionals, the other for activities and material geared toward the public. The NBL committee consists of a legally qualified chairperson and 11 members: six represent industry, three the general public, and two are medical experts. The LIF appoints the entire committee; however, the representatives of the general public and medical experts are appointed following consultation with an appropriate body or authority representing consumers and the Swedish Medical Association, respectively.
Fig. 2. Flow diagram of selected complaints, cases, and violations in the United Kingdom (A) and Sweden (B) 2004–2012.
Fig. 3. Complaints, rulings of breach, and complainants in the United Kingdom and Sweden 2004–2012.
(A) and (B) show the number of registered complaints and cases ruled in breach in the UK and Sweden, respectively (total registered complaints: n = 933 in UK, n = 916 Sweden; total cases ruled in breach: n = 597 in UK, n = 536 in Sweden). (A) also shows matters in breach in the UK (n = 1368). (C) Statutory copies of drug promotion sent by companies in Sweden to the IGM for scrutiny in 1998–2012 (n = 59,158). Dashed line indicates year 2004. (D) shows mosaic plot of registered complaints by type of complainant in each country.
Tab. 3. UK rulings of breach of selected clauses 2004–2012.
aPercentages indicate cell portion of total breaches. E.g., 5.2% of breaches pertained to §2.
In Sweden, over the same period, there were 972 rulings of breach of specific clauses (Table 4 for selected clauses; S2 Table for complete list). Just as for the UK, breaches regarding information, claims, and comparisons were most common, either concerning marketing aimed at health professionals (§4, 26%, n = 250), or at the public (§104, 7.5%, n = 73). In addition, 16% (n = 158) concerned violations of §8 or §10–§12, mandating appropriate documentation and references for claims, as well as fair comparisons. Moreover, as in the UK, a significant number of breaches (§2; 16%, n = 156, and §102; 10%, n = 100) concerned promotion prior to or inconsistent with the terms of the marketing authorization or the SPC, and 10% (n = 100) concerned promotion of prescription drugs to the public (§102). There were 54 breaches (5.6%) of §32–§42, which lay down rules on provision of items, goods, services, sponsorship, and hospitality to health professionals. The Swedish Code does not contain specific clauses on serious violations or failures of undertaking, thereby impeding comparisons among such clauses.
Tab. 4. Sweden rulings of breach of selected clauses 2004–2012.
aPercentages indicate cell portion of total breaches. E.g., 16% of breaches pertained to §2.
Fig. 4. Charges levied on companies by self-regulatory bodies in the United Kingdom and Sweden 2004–2012.
Charges in absolute amounts (A) and as percentage of estimated sales at manufacturers’ prices (B) for prescription medicines in the UK and prescription and OTC medicines in Sweden, respectively. Data for Sweden available since 2009.
There were no examples of non-economic sanctions in Sweden other than the standard publication of case reports. In the UK, there were 92 cases with one or more §2 ruling for a total of 102 §2 rulings (Table 3), i.e., violations highlighted as particularly serious by self-regulatory bodies, and which are always publicized in the form of advertisements appearing in the professional press. In addition, 19 §2 rulings were associated with one or more of the following non-economic sanctions: audit of the company (n = 14), public reprimand (n = 9), corrective statement (n = 2), recovery of promotional items (n = 1), or cash payment (n = 1), or temporary suspension from the ABPI (n = 3). Eight rulings did not involve breach of §2, but were associated with one or more of the following: audit of the company (n = 6), public reprimand (n = 2), or recovery of promotional items (n = 3). In summary, 110 non-economic sanctions (other than publication) were levied in the UK.
Fig. 5. Serious violations in the United Kingdom and Sweden 2004–2012: rulings of breach and complainants.
(A) Serious violation rulings per year in the UK (total n = 110) and Sweden (total n = 101). (B) shows mosaic plot of the source of the complaint for serious violation rulings in each country over the entire period. A few cases had multiple complainants.
Forty-six companies were ruled in breach for a serious offence at least once in both countries combined (n = 36 in the UK; n = 27 in Sweden), and seven companies were ruled in breach for a serious offence more than ten times: Pfizer (n = 19; 9.0%), Bayer (n = 16; 7.6%), GlaxoSmithKline (n = 13; 6.1%), Novo Nordisk (n = 12; 5.7%), Novartis (n = 12; 5.7%), AstraZeneca (n = 11; 5.2%), and Eli Lilly (n = 11; 5.2%) (S3 Table). In 2012, four of these companies ranked among the ten largest in terms of global drug sales, and all ranked among the 17 largest [29].
Tab. 5. Type and frequency of serious violation rulings: diabetes drugs and urologics.
aCase number ID: see S5–S8 Tables for additional information.
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