Speeding up Patients' Access to Medicines

Why it's important

The EU-US Transatlantic Trade and Investment Partnership (TTIP) is a negotiation that addresses a broad range of bilateral trade and investment policies, as well as global issues of common interest. It promises to boost economic growth on both sides of the Atlantic.

What's the timeline?

February 2013 EU-US High-Level working group on Growth and Jobs recommends an ambitious trade agreement.

June 2013 EU trade ministers approve negotiating mandate.

July 2013 Talks begin between European Commission & US government.

Talks expected to last 18-24 months.

Final agreement will need sign-off from EU trade ministers and the European Parliament.

Our point of view

Lilly welcomes the decision to launch TTIP negotiations.

What's needed and why?

TTIP should set ambitious standards for pharmaceuticals in the fields of regulatory harmonisation, intellectual property protection and enforcement, and market access to:

1. Ensure rapid access for patients to innovative new medicines

2. Support a European pharmaceutical industry which directly provides over 1.2 million highly skilled jobs in the transatlantic economy, *EFPIA and PhRMA 2012 figures

3. Be an appropriate benchmark for future trade agreements with other countries.

What are our priority issues?

Regulatory harmonisation

Benefit: Focused additional harmonisation between the European Medicines Agency (EMA) and the Food and Drug Administration (FDA) will reduce unnecessary duplication and pave the way for the development of global standards.

Key objectives: Increased collaboration

· Mutual recognition of inspections:

Recognise each other's Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP)inspections; the FDA and EMA have already taken steps to coordinate inspections assessing compliance with GMP and GCP. TTIP would go one step further by removing the need for duplicate inspections.

· Parallel scientific advice:

Expand the current programme to cover all medicines, enabling companies to pursue applications in both the EU and US and to conduct clinical trials based on a common approach.

· Quality by Design:

Expand the current pilot programme to allow for parallel evaluation or relevant development and manufacturing quality components submitted to both EMA and FDA, providing for better deployment of resources, potentially improving patient access to medicines and preventing shortages.

· Additional collaboration through the International Conference on Harmonisation (ICH):

Endorse the work of ICH and agree priority areas of focus.

Better Intellectual Property Protection and Enforcement

Benefit: A once-in-a-generation opportunity for the EU and US to set aligned high-standards for intellectual property (IP) protection and enforcement. This will contribute to incentivising the development of innovative medicines that meet patients' needs.

Key objective: increased alignment

· Regulatory data protection:

- Converge to the highest standards (i.e. 8+2+1 years for small molecules and 12 years for biologics).

- This will provide greater alignment and business predictability, as well as ensuring that the EU and the US continue to lead the world in support for pharmaceutical innovation.

· Patent enforcement systems:

- Allow for early resolution of patent disputes before an infringing product is launched on the market.

· The lack of predictability over enforcement in Europe is damaging for innovative companies and should be addressed in TTIP. It is important that patent disputes can be resolved before an infringing product is placed on the market. When infringement happens the innovative manufacturer, even if successful in that dispute, is rarely restored to the position that they would have been in if it weren't for the launch of the infringing product.

- Align the terms for granting an extension for paediatric medicines with those available in the US.

· Affirm high-level intellectual property principles and set out globally consistent IP protections:

- Include common understandings of provisions on patent standards; measures to restore lost patent life e.g. due to delays at the patent office and time taken during the marketing approval process; and the use of trademarks.

Ensured market access

Benefit: Pricing and reimbursement systems that reflect the value of the research and development process help create a stable and predictable environment. This will enable innovation to flourish and the biopharmaceutical industry to continue to bring new medicines to patients.

Key objective: Agreed principles on pricing and reimbursement

· The cost of developing a new medicine has escalated dramatically from about €600m in 2001 to €1bn today. Drug Discovery and Development: Understanding the R&D Process, www.innovation.org

· All aspects of the biopharmaceutical industry - including R&D, manufacturing and sales and marketing - are intertwined. A negative approach towards one element could damage the EU's overall attractiveness for global investors. Without a supportive and collaborative environment, biopharmaceutical innovation may shift overseas to more competitive environments.

· Market access is critical to ensure that patients rapidly gain access to new treatments, as well as to help companies more rapidly recoup their investment in research and maintain direct and indirect employment. TTIP is an opportunity to include a Pharmaceutical Annex similar to that in the EU-Korea and US-Korea trade agreements, covering agreed principles for pricing and reimbursement.