Abstract
The main issues discussed in this report concern competition problems in the pharmaceutical sector that are dealt with directly or indirectly by the competition rules or specific sectorial non-competition legislation. Swedish Competition Law enforcement has been, so far, sporadic at best, and has not addressed particularly “sexy” issues such as hardcore cases of refusal to license and pay-for-delay settlement agreements. Instead, the Swedish non-competition sectorial rules for pharmaceuticals are of more interest. In particular, they have dealt with the issue of securing access to medical drugs for consumers while keeping costs down for the state. This has required a difficult balancing exercise, in particular as far-reaching obligations to supply as well as the ambition to secure access may result in competition problems by imposing entry barriers and resulting in a higher concentration at the wholesale level of trade. On the other hand, state subsidies of medical drugs with the aim of protecting consumers have also resulted in promoting of competition between original drugs, parallel traded drugs and generics. In effect, it seems as this has also been an effective tool in order to promote competition and decrease costs for the public purse.
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- 1.
ECJ, case C-438/02, Krister Hanner, ECLI: EU:C:2005:332.
- 2.
The most common travaux preparatoires used and referred to in this chapter are the proposal for new legal act (proposition, abbreviated as prop. followed by the year and number [prop. XX/XX:YY]) and the governmental reports preceding a proposal (statens offentliga utredningar, abbreviated as SOU followed by year and number [SOU XXXX:YY]).
- 3.
This includes the Swedish Marketing Act, Marknadsföringslagen (2008:486) (MFL), that implements the EU Unfair Commercial Practices Directive (2005/29/EC) marketing practices.
- 4.
Ch. 2, Section 1 KL, states that “[a]greements between undertakings shall be prohibited if they have as their object or effect, the prevention, restriction or distortion of competition in the market to an appreciable extent, if not otherwise regulated in this act.” As in EU Competition Law, Ch. 2, Section 2 KL, provides for an exemption stating that ”[t]he prohibition in Article 1 does not apply to agreements which (1) contribute to improving the production or distribution or to promoting technical or economic progress; (2) allow consumers a fair share of the resulting benefits; (3) only impose on the undertakings concerned restrictions which are indispensable to the attainment of the objective referred to in paragraph 1, and (4) do not a afford such undertakings the possibility of eliminating competition in respect of a substantial part of the utilities in question.”
- 5.
Ch. 2, Section 7, states that “[a]ny abuse by one or more undertakings of a dominant position on the market shall be prohibited. Such abuse may, in particular, consist in […]”
- 6.
Ch. 4, Section 1 KL, states that “[a] concentration shall be prohibited, if it significantly restrains occurrence or the development of effective competition within the country as a whole, or a substantial part thereof. During the examination of the concentration and the question whether it will be forbidden account shall specially be taken to whether it creates or strengthens a dominant position […] To the extent that the creation of a joint venture, which constitutes a concentration […] has the aim or effect of coordinating the competitive behaviour of the undertakings which remain independent, in the examination of a prohibition against the concentration, the co-ordination shall be appraised in accordance with Chapter 2, Articles 1 and 2.”
- 7.
Ch. 3, Section 1 KL.
- 8.
At the time of writing the national report for the LIDC, the cases were appealed to the Market Court, an independent court for competition and marketing law cases.
- 9.
Ch. 3 section 24 KL.
- 10.
Ch. 4 section 2 KL; Ch. 4 section 4 KL.
- 11.
This excludes merger cases.
- 12.
See e.g. Lag 2008:583.
- 13.
In an early case under the KL1993 the KKV found that a regional authority providing obligatory public health services by purchasing/procuring health services did not constitute an undertaking under competition law (KKV decision no. 1434/93 VSSO). The KKV was ambiguous as whether the public health services offered by the Regional authority constituted economic activity. Arguably, an entity that offers public health services that are not qualified as economic activity, would not constitute an undertaking under the KL when carrying out the purchasing activity. Such a view would also correspond to the current position in EU Competition Law. In any case, whether this particular exclusion is applicable must be assessed in the light of the individual circumstances of the case.
- 14.
Ch. 12 and 14 LL.
- 15.
Ch. 14 LL.
- 16.
The KKV made an inquiry to the distribution of medical drugs following the liberalization of the retail monopoly for the sales of medical drugs (KKV decision no. 340/2007). The KKV’s sector inquiry purported in particular to identify behavior by the ex-monopolist that could potentially harm the liberalization process. Amongst the measures suggested by the report was the separation between the former monopolist (that would continue to act within the market retailer of drugs) and certain infrastructure that at the time was deemed crucial for new entrants into the retail market for medical drugs.
- 17.
Proposal to the KL 1993, prop. 1992/93:56 pp. 21 and 62.
- 18.
See Lag 2008:583 on restrictive R&D agreements; Lag 2008:586 on restrictive technology transfer agreements; Commission Regulation 1217/2010 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to certain categories of research and development agreements (Regulation 1217/2010), OJ 2010 OJ 335/36; Commission Regulation 316/2014 of 21 March 2014 on the application of Article 101(3) of the Treaty on the Functioning of the European Union to categories of technology transfer agreements (Regulation 316/2014), OJ 2014 L 93/17.
- 19.
See the Guidelines on the application of Article 101 TFEU on technology transfer agreements, OJ 2014 C 89/3. See also the guidelines on horizontal agreements, OJ 2011 C 11/1.
- 20.
Ch. 4 section 44 PL.
- 21.
KKV decision no. 645/96.
- 22.
KKV decision no. 1338/93.
- 23.
Regulation 316/2014, Article 4(1) and (2).
- 24.
KKV decision no. 1434/94.
- 25.
KKV decision no. 814/94.
- 26.
KKV decision no. 1101/93.
- 27.
KKV decision no. 1163/95.
- 28.
KKV decision no. 706/2008.
- 29.
See e.g. the KKV decisions no. 185/1998 (Kronans Droghandel), no. 971/93 (Kronans Droghandel) and no. 1220/93 (ADA).
- 30.
KKV decision dnr 993/2000.
- 31.
KKV decision dnr 2007/340.
- 32.
Section 8 LF.
- 33.
Sections 15–17 LF.
- 34.
For more information on the assessment made by the TLV and the different relevant factors in the setting of prices see http://www.tlv.se/Upload/English/ENG-guide-for-companies.pdf).
- 35.
Ch. 4 Section 22 LL.
- 36.
Section 21 LF.
- 37.
Prop. 2001/02:63, p. 58.
- 38.
SOU 2012:75, Ch. 14, pp. 619–676.
- 39.
The so-called Cimzia case, no. 3596-14.
- 40.
Ch. 2, Section 5 LHL, see also prop. 2008:09145, pp. 144–146.
- 41.
Prop. 2013/14:93, p. 99.
- 42.
Section 21(a) LF.
- 43.
Prop. 2013/14:93, pp. 165–168.
- 44.
Section 25 LF.
- 45.
Ch. 3, Section 3 LHL.
- 46.
Prop. 2008/09:145, pp. 157–160.
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Bastidas Venegas, V. (2017). Sweden. In: Kobel, P., Këllezi, P., Kilpatrick, B. (eds) Antitrust in Pharmaceutical Markets & Geographical Rules of Origin. LIDC Contributions on Antitrust Law, Intellectual Property and Unfair Competition. Springer, Cham. https://doi.org/10.1007/978-3-319-55813-4_12
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