Personalised Medicine in Health Care Systems and EU Law: The Role of Solidarity?

Mathur and Sutton (2017), pp. 3–5.

Jain (2015), p. 1.

Council (2015).

Council (2014).

European Commission (2013).

Article 168(7) Treaty on the Functioning of the European Union (consolidated version) OJ C 202, 7.6.2016 (hereinafter: TFEU).

Article 168(1) TFEU.

E.g. Articles 11 and 12 TFEU.

Article 168(5) TFEU.

Although the EU’s competence in the area of public health is still very limited, it nevertheless “[…] provides the basis for governing at a distance”. See Flear (2015), p. 40.

Measures are adopted in accordance with the ordinary legislative procedure, upon consultation with the Economic and Social Committee and the Committee of the Regions (Article 168(5) TFEU).

Regulation (EU) No 282/2014 of the European Parliament and of the Council of 11 March 2014 on the establishment of a third Programme for the Union’s action in the field of health (2014–2020) and repealing Decision No 1350/2007/EC, OJ L 86, 21.3.2014.

Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020—the Framework Programme for Research and Innovation (2014–2020) and repealing Decision No 1982/2006/EC, OJ 347/104, 20.12.2013.

Flear (2015), p. 72.

For a thorough account of the EU approach in supporting research and new health technologies, see Brosset and Mahalatchimy (2017), pp. 197–221.

In German literature, the term ‘individualised medicine’ (‘individualisierte Medizin’) is preferred over the term ‘personalised medicine’. For the detailed conceptual analyses of both terms see Keil (2015), pp. 18–21. Although conceptually not entirely identical, these two terms are often used interchangeably in legal and medical academic literature, see Becker (2016), p. 23; Wienke et al. (2014), Grech and Grossman (2015), and Jain (2015), pp. 1–5.

See, e.g. Council (2015). Personalised medicine allows stratification of patients into groups based on their biomarkers to tailor medical intervention to a particular group of patients, which is more efficacious than the dominant ‘one size fits all’ approach. See European Commission (2013), pp. 5–6.

Pavelić et al. (2016), p. 3.

See more Mićović et al. (2016), pp. 81–93; Becker (2016), pp. 21–29.

Guglielmi Gaetano, presentation at the Personalised medicine conference 2016 Brussels, Challenge 5 Shaping sustainable healthcare, available at https://​ec.​europa.​eu/​info/​events/​personalised-medicine-conference-2016-2016-jun-01_​en.

Ricciardi Walter, presentation at the Personalised medicine conference 2016 Brussels, A framework on impact of PM in national health systems, available at: https://​ec.​europa.​eu/​info/​events/​personalised-medicine-conference-2016-2016-jun-01_​en.

Council (2015).

Hüsing et al. (2008), p. 282.

Hüsing et al. (2008), p. 283.

See Hüsing et al. (2008), p. 291.

See, for example, Genetics Home Reference, What is the cost of genetic testing, and how long does it take to get the results?, https://​ghr.​nlm.​nih.​gov/​primer/​testing/​costresults; Breastcancer.​org, Genetic testing facilities and cost, http://​www.​breastcancer.​org/​symptoms/​testing/​genetic/​facility_​cost.

European Commission (2013), pp. 24–25.

Pavelić et al. (2015), p. 134.

See, e.g. Joyner and Paneth (2015), Brittain et al. (2017), p. 551; Maughan (2017), p. 17; Haycox et al. (2014), p. 1058.

The World Health Organisation (WHO) defines health technology as “the application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve a health problem and improve quality of lives”, see WHO Resolution (2007) WHA60.29. The UK National Institute for Health and Clinical Excellence (NICE), one of the leading health technology assessment organisations in the world, defines health technology as “[A]ny method used by those working in health services to promote health, prevent and treat disease, and improve rehabilitation and long-term care. Technologies in this context are not confined to new drugs or medical technologies.” See NICE Guide to the methods of technology appraisal 2013, Glossary, available at https://​www.​nice.​org.​uk/​process/​pmg9/​chapter/​glossary#health-technology; see also the definition of health technology in the EUnetHTA Strategy 2012 and beyond, available at: http://​www.​eunethta.​eu/​sites/​default/​files/​sites/​5026.​fedimbo.​belgium.​be/​files/​EUnetHTA%20​Strategy%20​2012%20​and%20​beyond.​pdf. One of the earliest definitions was applied by the U.S. Office of Technology Assessment, which describes medical technology (later referred to in broader term as ‘health’ technology) as “drugs, devices, and medical and surgical procedures used in medical care, and the organisational and supportive systems within which such care is provided”, see Office of Technology Assessment, Assessing the efficacy and safety of medical technologies, Washington DC: U.S. Government Printing Office, 1978. Health technologies, as noted by some authors, are not defined as a single regulatory category by the EU, as evident in the definition of health technologies for Patients’ Rights Directive, in comparison with the EU marketing legislation, such as Directive 2001/83, Directive 93/42 or Regulation 726/2004. See Bache et al. (2013), p. 9.

Article 3(1)(l) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare, OJ L 88, 4.4.2011 (hereinafter: the Patients’ Rights Directive).

European Commission (2018).

Article 2(1)(d) of the Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU COM(2018) 51 final.

European Commission (2013), p. 26.

Although HTA reports may and have been used by a range of decision makers, they are increasingly being commissioned to inform particular resource allocation decisions. In comparison to other concepts which enable evidence-based decision making, such as evidence-based medicine (EBM) or comparative effectiveness research (CSR), HTA “explores of elements of value of a technology […]” with the underlying question “[…] “Is the technology worth it?” […]”. See Drummond et al. (2008), pp. 244–258.

Both reference pricing and health technology assessment can be viewed as policies designed to obtain “more value for money from pharmaceuticals”. Reference pricing is based on clustering of similar drugs and setting a single level of reimbursement for the cluster, “usually based on the price of the cheapest drug in the group or some average of existing prices.” Drummond et al. (2011), pp. 263–264.

Luce et al. point out the outputs of CER activities are useful for developing clinical guidelines, whereas HTA output consist primarily in informing reimbursement and coverage decisions. See Luce et al. (2010), pp. 271–272.

Luce et al. (2010), pp. 265–266.

Council (2015), para. 22.

European Alliance for Personalised Medicine, Innovation and Patient Access to Personalised Medicine, Report from Irish Presidency conference March 20th/21st 2013, https://​www.​euapm.​eu/​pdf/​EAPM_​REPORT_​on_​Innovation_​and_​Patient_​Access_​to_​Personalised_​Medicine.​pdf, p. 22. See also Di Paolo et al. (2017), p. 289.

O’Donnell et al. (2009), p. 4.

European Commission (2018), p. 2.

Banta (1997), p. 133.

As pointed by O’Donnell et al. “The refrain, if you have seen one HTA system, you have seen them all, simply does not apply.” See O’Donnell et al. (2009), p. 3.

Banta (2003), p. 122.

For an overview of HTA agencies and HTA system in the EU Member States, see Löblová (2016), pp. 253–273.

Act on Quality of Health Care and Social Welfare (Zakon o kvaliteti zdravstvene zaštite i socijalne skrbi), Official Gazette Narodne novine No. 124/11.

Mittermayer et al. (2010), p. 430.

Article 2 Act on Quality of Health Care and Social Welfare (Zakon o kvaliteti zdravstvene zaštite i socijalne skrbi), Official Gazette Narodne novine No. 124/11.

Article 2 Act on Quality of Health Care and Social Welfare.

Draft Ordinance was open for public consultations before its adoption in the period from 11 October to 10 November 2016, during the operation of a technical government. On 19 October, the 14th Government of the Republic of Croatia took office, and it seems that the competent Ministry of Health indefinitely postponed all further activities concerning the adoption of the Ordinance. For the text of the draft Ordinance from 2016 see https://​zdravstvo.​gov.​hr/​pristup-informacijama/​savjetovanje-sa-zainteresiranom-javnoscu-1475/​otvorena-savjetovanja/​nacrt-prijedloga-pravilnika-o-procjeni-zdravstvenih-tehnologija/​2784.

The Croatian Guideline for Health Technology Assessment Process and Reporting (2011), http://​aaz.​hr/​sites/​default/​files/​hrvatske_​smjernice_​za_​procjenu_​zdravstvenih_​tehnologija.​pdf.

HTA 5/2013, http://​www.​aaz.​hr/​sites/​default/​files/​hta_​05_​2013.​pdf.

See Martinović (2015), pp. 335–352.

Council (2006).

Without the respect for the “[…] general duty of solidarity, from which no one is absolved […], the state would be deprived of the resources that allows for the provision of social security”. See Supiot (2015), pp. 114–115.

Saltman (2015), p. 5; Brown and Chinitz (2015), p. 27. See also Kingreen (2003).

Ter Meulen (2017), p. 185.

Prainsack and Buyx (2017), p. 137.

Prainsack and Buyx (2017), p. 137.