The Transatlantic Trade and Investment Partnership: achieving the potential

In Eli Lilly and Company's latest article, Dave Ricks provides an overview of the Transatlantic Trade and Investment Partnership (TTIP) and shares his thoughts on why the TTIP is a great opportunity for pharma.

Like many multinational companies, Lilly is increasingly researching and manufacturing medicines for the whole world, and not just a single market. The lack of alignment on international standards for intellectual property protection, regulation and market access diminishes our ability to bring affordable, high-quality medicines to more of the world's population. Because we are in the business of producing treatments and cures, these shortcomings represent a real tax on public health.

The Transatlantic Trade and Investment Partnership, or TTIP, is one of our best opportunities to address these challenges. Official negotiations between the U.S. and EU will soon be underway, with the goal of reaching an agreement by the end of 2014. As I recently explained in testimony to the U.S. Senate Finance Committee, an ambitious, comprehensive, and high-standard agreement will help our industry develop a generation of new medicines that benefit patients and contribute to economic growth and prosperity worldwide. Specifically, there are three key areas that should be addressed.

Intellectual property rights

The innovative biopharmaceutical industry relies on strong intellectual property protection and enforcement to recoup the steep R&D investments. Creating a new medicine takes 10 to 15 years on average, and costs approximately $1.3 billion USD. Yet, only one in five approved medicines will ever recoup the cost of R&D investment.

"...an ambitious, comprehensive, and high-standard agreement will help our industry develop a generation of new medicines..."

Strong intellectual property protections will pave the way for new and promising advancements for patients. For example: 12 years of regulatory data protection for biologics, as is now law in the U.S., will ensure that this emerging avenue of medicine continues to benefit from robust investments.

Other aspects of intellectual property protections affect our ability to succeed. For example, it's important to clarify patentability standards – such as the criteria that must be met to demonstrate novelty – and implement patent term adjustments that will incentivize investment in biopharmaceutical R&D. Adopting effective patent enforcement systems is also critical. Allowing an infringing product to enter the market during a dispute harms the innovative manufacturer – very often irreparably. Enforcement systems should allow for early resolution of patent disputes before an infringing product is made available.

Regulatory compatibility

Regulatory differences and duplicative requirements in the U.S. and EU can impede global drug development, review and evaluation. Addressing these issues head on will enhance efficiency, reduce redundant testing, and optimize the use of limited regulatory agency resources. As always, our goal should be to expedite patient access to new, innovative, life‐saving medicines.

Significant partnership already exists between the U.S. Food and Drug Administration and European Medicines Agency – both bilaterally and internationally – but we can build on efforts to have an even greater impact. For example, the U.S. and EU should recognize each other's Good Manufacturing Practices and Good Clinical Practices inspections. This coordination would reduce a significant amount of the regulatory burden on sponsors and agencies.

"Regulatory differences and duplicative requirements in the U.S. and EU can impede global drug development, review and evaluation."

As we deepen the ties of trade and investment, we must also ensure responsible data sharing that protects patient privacy, maintains the integrity of the regulatory review process, and preserves incentives for biomedical research. Modern data systems create unique challenges for data protection that should be addressed in any agreement.

Market access

Reducing non‐tariff barriers will incentivize innovation. In most markets, access to biopharmaceuticals is dependent not only on manufacturers meeting strict regulatory approval standards, but also obtaining reasonable government pricing and reimbursement decisions. Both the U.S. and the EU have included specific pharmaceutical (and medical device) chapters in recent free trade agreements addressing these challenges. Those provisions were designed to ensure that regulatory approval and reimbursement are governed by transparent and verifiable rules founded on science‐based decision making.

Building on the common provisions contained in the pharmaceutical and medical device chapters of the U.S. and EU free trade agreements with Korea, we hope the TTIP will adopt meaningful general principles and pricing policies that reflect the real values and concerns of all parties in the healthcare system. It is also important to promote transparent government regulation, and eliminate onerous taxes and barriers to markets and patients.

Though the TTIP is being negotiated between the U.S. and EU, we must remember that innovation is global. Our intellectual property-driven economies – and indeed the biopharmaceutical industry's treatments and cures – are intimately connected to the rest of the world. It is critical to ensure alignment between the U.S. and the EU as we all engage with third parties, such as India, China, and Canada, thereby promoting high biopharmaceutical policy standards and access to innovative medicines throughout the world. TTIP is a once-in-a-lifetime opportunity to address longstanding trade issues, create new markets, and simplify transatlantic business. If we work together with open minds and a true commitment to progress, we can continue to drive economic growth and improve the health of patients around the world long into the future.

The next article by Eli Lilly and Company 'Countering counterfeit drugs' can be viewed here.

About the author:

Dave Ricks was named senior vice president and president of Lilly Bio-Medicines in January 2012, and is a member of the company's executive committee. His responsibilities include more than 20 countries, among them the world's largest pharmaceutical markets, including the U.S. and Japan, along with Lilly's ACE region (Australia, Canada, and Europe).

How can pharma maximise the potential of the TTIP?