High prices, poor access: the EU medicines market and Big Pharma

→ Full report: "High prices, poor access"

The emergence of extremely expensive medicines – with price tags in the tens and hundreds of thousands of euros, which are vastly disproportionate to their development and production costs - owes much to industry-friendly regulation and intellectual property (IP) rules. While civil society has been ringing alarm bells about these issues for years, the European Council in 2016 finally recognised the problem. It asked the European Commission to review whether the system of incentives and rewards for pharmaceutical companies was out of balance.

In the face of this review, Big Pharma's lobby machine geared up to defend its privileges, doing its best to remove or weaken regulatory measures. A close relationship with the Commission – which has so far failed to take undue industry influence seriously – has played a key role, as has the sector's lobbying firepower.

The top ten biggest spending companies have increased their lobby budget by €2 million since 2015.

The top ten highest spending companies, for example, have increased their lobby budget by €2 million since 2015, and Big Pharma's main lobby group EFPIA (European Federation of Pharmaceutical Industries and Associations) sits on eight of the Commission’s advisory groups. Big Pharma has also rolled out a PR offensive harnessing the powerful emotions around illness, designed to deflect criticism and to narrow the scope for debate. Thanks to this lobbying arsenal, the industry has succeeded in influencing the review of pharma incentives and rewards (such as intellectual property rules), as well as effecting a change to a so-called supplementary protection certificate (SPC), a patent extension which allows companies to extend the period of monopoly pricing.

Big Pharma lobbying has also had an impact on a proposal for cross-European collaboration to assess how effective new medicines and health technologies are relative to existing ones, something which helps member states negotiate prices. Drug companies promote the use of ‘new’ drugs over old ones, as the former still have patent protection and are therefore more expensive, even if the new product is not an improvement in medical terms.

Medicines policy must be protected from the undue influence of Big Pharma.

But all is not lost. In response to a crisis of high prices, lack of access, and too few new medicines that represent real therapeutic advances, the appetite for radical change remains high. We urge the incoming European Parliament and Commission to ensure that medicines policy is protected from the undue influence of Big Pharma.

Narrow commercial interests should not undermine public health priorities and the industry’s fear-mongering must not narrow the scope for transformative change. The EU institutions should keep working towards EU-wide cooperation for robust and independent assessments of new drugs, stop promoting expanded IP provisions through trade deals, and support discussions around better ways to finance medicines research, which ensures public-interest return on public investment.

Chapters:

 

• Executive summary
  
   
• Chapter 1) Introduction: The changing political context around high-price medicines
  
   
• Chapter 2) EFPIA and Big Pharma's web of lobbying in Brussels
  
   
• Chapter 3) When a pharma-embedded consultancy reviews the EU's pharma model
  
   
• Chapter 4) Patent extensions: helping keep drug prices high for longer
  
   
• Chapter 5) EU HTA proposal: the need to safeguard against industry influence
  
   
• Chapter 6) Conclusion & Recommendations