Index FOREWORD RECOGNISING CHANGE: SCENARIOS THAT ARE NO LONGER SO FUTURISTIC AND NEW/OLD HEALTH EMERGENCIES 1.1 World trends in medicine in 2016 1.2 The new European Regulation on clinical trials 1.3 Sharing clinical trial data: a collective responsibility 1.4 International cooperation and new public-private partnerships for research on new medicines 1.5 EPSCO conclusions on personalised medicine promotion and focus on the EU dementia emergency 1.6 New guidelines published on the EMA website for the development of treatments for Alzheimer-type dementia
5
1.
2. 2.1 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9
VACCINES AND ANTIBIOTICS. PRIMARILY A CULTURAL QUESTION Vaccines: victims of their own success (Dis)information on vaccines: a challenge to overcome How to tackle the rejection of vaccinations. Choosing between coercion and persuasion? Immunisation strategies and the importance of defining a sustainable price for vaccines Antimicrobial resistance: how to tackle a global threat Antibiotic resistance: a global risk that requires shared strategies Being born in an era of antibiotic resistance Antibiotics and prescriptive appropriateness: three possible actions to guide doctors Combatting antimicrobial resistance at the global level. Regulatory initiatives in Europe and in the United States
MANAGING THE CHANGE: THE GOVERNMENT AND PLANNING PHARMACEUTICAL EXPENDITURE 3.1 The “sofosbuvir case”. Transparency and responsibility in the “positioning” of innovative medicines 3.2 Innovative strategies for the sustainability of pharmaceutical expenditure: the example of the Italian Medicines Agency in Europe and in the international press 3.3 Prices of medicines in Europe: a European Commission report examining the pricing strategies in-depth 3.4 Pharmaceutical research, access to innovation and sustainable price policies. Towards new models of collaboration between stakeholders
9 10 18 23 25 28 31 35 36 38 41 43 46 50 53 55 57
3.
63 64 69 75 79
3