Handling pharmaceutical risks in post-trust society: Science-based decision making under strain?

Decisions to ban or restrict particular products or technologies often involve risk-related claims, for example in the case of hormones in beef or genetically modified organisms (GMOs). Such disputes have triggered comparisons about the nature of the risk assessments conducted on both sides of the Atlantic, in particular the question of which trade block might be more precautionary, or whether one trade block is inherently more precautionary (Löfstedt and Vogel 2001; Wiener and Rogers 2002; Wiener et al. 2011; Vogel 2012). The programme of the topical conference organised at Maastricht University on 14-15 April 2010 highlighted, in the author’s view rightly so, the fact that ‘European and WTO rules put a focus on science in their attempt to ensure that measures adopted by Member States and/or the EU are inspired by genuine non-trade rather than protectionist motives and intentions’. This chapter takes a closer look at the process put in place to mobilise science and translate genuine non-trade concerns into workable measures in a sector of high value for the global economy and public health, namely, pharmaceuticals. According to the European Commission Directorate-General for Trade, the

EU is the second largest manufacturer of pharmaceuticals, with 31.1 per cent of world output (2008). The pharmaceutical sector is the fifth largest sector in the Union and employs over 600,000 people. Europe is a net exporter, with a trade surplus of €35 billion in 2009. The US market receives a third of these exports. On the other hand, regulatory decisions involve a difficult balancing of benefits and risks to human health, which takes place at global, (Vogel 1998; Abraham and Lawton Smith 2003; Harman 2004), European (Permanand 2006) and national levels. The meeting of global public health objectives, for example the eradication of major diseases (e.g. HIV – human immunodeficiency virus) and the promotion of immunisation programmes, requires the balancing of speedy circulation and distribution of pharmaceutical products with approaches to deal with drug-related risks. The Erice Declaration of 1997 (Hugman 2006) offers an insight into how science may be mobilised to deal with pharmaceutical risks, when it calls for ‘independent

expertise to ensure that safety information on all available medicines is adequately collected, impartially evaluated, and made accessible to all’. Meeting this requirement has been the source of a good deal of confusion

at the core of the European decision-making system when the European Parliament refused to sign off the 2009 budget of the European Medicines Agency (EMA) after Members of the European Parliament (MEPs) criticised the EMA over conflicts of interests (Watson 2011). The result has been to strengthen the trend towards more transparency and disclosure (Löfstedt and Bouder 2013). Critical questions may be raised: how do pharmaceutical regulators use scientific evidence in the ‘real’ world of risk decisions? In particular, how do governments mobilise and use knowledge when they are confronted by imminent perils? What are the consequences for ‘the protection of human health and the environment’? This chapter draws on evidence from seven case studies developed between

2003 and 2010. Two of these looked at the regulation of MMR (measles, mumps and rubella) and Hepatitis B vaccines (Bouder 2006), one studied cardiovascular biomarkers (Bouder 2007), one analysed impurities in pharmaceuticals (Bouder 2008), and finally three case studies looked at the quality and safety issues in a weight-control drug, an anti-HPV (human papillomavirus) vaccine and an anti-HIV medicine (EMA 2011). This chapter is divided into three parts. The first part draws on the background of the seven case studies to analyse the changing nature of the context in which policy decisions are taken. Scientists and policy makers are confronted by a ‘post-trust environment’ where expert-based decision making is increasingly challenged. The second part focuses on two of the studied cases, those on the anti-HIV drug Viracept and the anti-HPV vaccine Gardasil, where genuine non-trade protection measures have been at odds with public health and global supply objectives. The third and final part presents an analysis of the cases and some recommendations as to how to handle protection measures more effectively.