Archives

“Adaptive Licensing” or “Adaptive Pathways”: Deregulation Under the Guise of Earlier Access

POLICY BRIEF Developed by: Health Action International, The International Society of Drug Bulletins, The Medicines in Europe Forum, The Mario Negri Institute for Pharmacological Research, The Nordic Cochrane Centre, WEMOS Executive Summary Adaptive licensing”…

16 October 2015

Empty Gestures – The EU’s Commitments to Safeguard Access to Medicines

Review of the European Union’s Trade and Investment Policy, 2015 Introduction Health Action International (HAI) and Médicines Sans Frontières (MSF) welcome the revision of the European Union’s (EU) trade and…

14 October 2015

Direct Patient Reporting in the EU: A Snapshot of Reporting Systems in Seven Member States

I. Introduction Adverse drug reactions (ADRs) are a serious public health concern. It is estimated that 5% of all hospital admissions in the European Union (EU) are due to an…

16 September 2015

Trading Away Access to Medicines – Revisited

Insufficient innovation and a lack of access to affordable medicines are major barriers to achieving the right to health in low- and middle-income countries. The lack of a vaccine or…

29 September 2014

Mapping External Reference Pricing Practices for Medicines

EXECUTIVE SUMMARY Objectives One option to manage or regulate medicine prices is External Reference Pricing (ERP) which is increasingly being used worldwide, particularly in higher- income countries, or being considered…

1 September 2014

Variations in Prices and Reimbursement of Medicines in the European Union

Report and Methodology | 5 June 2014 | Report | Methodology Universal healthcare, access to good quality care, solidarity and equity are all values to which European Union (EU) Member…

Working Paper 4 – Competition Policy

Executive Summary Competition can reduce prices for medicines and increase availability if the right conditions are in place. There is good evidence that: Generic medicine entry and generic competition increase…

1 February 2014

Policy Brief 3 – Regulation of Mark-ups in the Pharmaceutical Supply Chain

Studies of medicine price components in low- and middle-income countries (LMICs) show variable and often high cumulative mark-ups, from 17%-84% in the public sector and 11%-6,894% in the private sector….

1 February 2014

Policy Brief 5 – Sales Taxes on Medicines

Taxes commonly make up 20-30% of the final price people pay for medicines (1). Reducing or removing taxes on medicine sales may reduce prices and improve access. The objectives of…

1 February 2014

Policy Brief 6 – The Role of Health Technology Assessment in Medicine Pricing and Reimbursement

What is the policy? Health technology assessment (HTA) is a multidisciplinary policy analysis of the medical, economic, social and ethical implications of development, diffusion, and use of health technology, including…

1 February 2014

Policy Brief 2 – The Role of Health Insurance in the Cost-effective Use of Medicines

What is the role of health insurance in cost-effective medicines use? Medicines spending may often be high enough to cause poverty in LMICs. Around half of LMIC households spend all…

1 February 2014

Working Paper 1 – External Reference Pricing

Executive Summary The high price of medicines is a major concern for policy-makers, insurers and patients. High prices can make medicines unaffordable, compromising equitable access to them, and threaten the…

1 February 2014

Working Paper 6 – The Role of Health Technology Assessment in Medicine Pricing and Reimbursement

Executive Summary This review aims to identify and describe the role of health technology assessment (HTA) in the price-setting and reimbursement of pharmaceuticals with a focus on its use in…

1 February 2014

Policy Brief 4 – Competition Policy

Competition can reduce medicine prices and increase availability if the right conditions are in place. Competition is not effective unless there is credible medicine quality regulation and other supportive policies….

1 February 2014

Policy Brief 1 – External Reference Pricing

What is the policy? ERP uses the prices of identical medicines in one or more reference countries to derive a benchmark or reference price for the purpose of setting or negotiating the national…

1 February 2014

Working Paper 2 – The Role of Health Insurance in the Cost-Effective Use of Medicines

Executive Summary Health insurance systems have great potential to improve the cost-effective use of medicines by leveraging better provider prescribing, more cost-effective use by consumers, and lower prices from pharmaceutical…

1 February 2014

Working Paper 5 – Sales Taxes on Medicines

Executive Summary Domestic taxes can comprise a substantial proportion of the price people pay for medicines, and high prices are generally considered to be a principal barrier to access to…

1 February 2014

Working Paper 3: The Regulation of Mark-ups in the Pharmaceutical Supply Chain

Executive Summary This paper reviews the literature on the regulation of pharmaceutical distribution mark-ups in low- and middle-income countries (LMICs) with a view to describing and analysing the current knowledge….

1 February 2014

Transparency of Clinical Trial Data on Medicines in the EU

Introduction Estimates indicate that 5% of all hospital admissions are caused by an adverse drug reaction (ADR)1 and that ADRs are the fifth most common cause of hospital death.2 Discussions…

Divide and Conquer: A look behind the scenes of the EU pharmaceutical industry lobby

Policy Report | March 2012 | Download PDF Executive Summary This report surveyed the entries made by pharmaceutical companies and their representatives in the EU’s lobby Transparency Register to find out how…

Universal Access to Medicines for Non-Communicable Diseases

High medicine prices know no bounds – they affect all countries, all diseases, and affect all people (both directly and indirectly). But the greatest price is paid by those who…

1 September 2011

Direct Patient Reporting of Adverse Drug Reactions

The European Parliament is now discussing changes to the legislation on pharmacovigilance systems, which Member States will then adopt to harmonize national adverse events systems. An important change to the…