Building a Thriving Innovative Life Sciences Sector:
In continuation of EFPIA’s #HealthyEU campaign calling for an integrated life sciences strategy in the EU, today’s guest blog comes from Dave Ricks, Senior Vice President, Lilly & President, Lilly Biomedicines and U.S. Co-Chair of the Trans-Atlantic Business Dialogue (TABD) Program.
In this post I want to look at the strength of pharmaceuticals as a European industry sector, creating jobs and exports for the EU, as well as the potential we have to transform the lives of patients.
In 2012 the pharmaceutical industry generated a positive trade balance of more than €54.4bn, far ahead of other high technology industries like power generating machinery, IT or telecommunications.
Employment productivity is also highest in the pharmaceutical sector. Our sector outperforms all other leading industries in two key measures: value added per employee and turnover generated per employee. Members of the EFPIA directly employ 700,000 people, 20% of whom are involved in R&D.
Despite the long period of economic contraction in Europe, our industry has held on to its employees, and maintained high levels of R&D investment – to the tune of €30 billion annually.
As an industry, we are very much aware that we cannot rest on our past and current achievements, and we need to ensure a stable environment to continue developing new and better treatments for patients. This process continues getting tougher every year. It is estimated that developing a new medicine takes 10-15 years on average, costing approximately €1.2 billion.
According to EFPIA, every European lives over 18 years on average with a disability or illness. This not only has a devastating impact on individuals, their families and carers, but a major bearing on European economies and labour markets.
Chronic diseases account for 75% (over €700bn) of Europe’s healthcare bill and are responsible for up to a 7% GDP loss in some EU countries.
A Transatlantic Trade and Investment Partnership (TTIP) represents a key opportunity to remain competitive and to strengthen transatlantic pharmaceutical discovery. Europe and the US account for more than 75% of global R&D in life-sciences, 1.4 million jobs in the sector, and 80% of global sales of new medicines.
TTIP can tackle issues that hinder the true potential of the transatlantic pharmaceutical market. In order to unlock this potential, we need an ambitious, comprehensive agreement that addresses regulatory compatibility; upholds intellectual property protection and enforcement; and seeks greater market access and transparency.
We expect TTIP can contribute to reconcile divergences between the systems and reduce bureaucratic barriers to trade while ensuring consumers’ greater access to safe, high-quality medicines. We are not talking about de-regulating or about lowering standards; on the contrary, our industry seeks harmonization towards the highest standards to facilitate and spur innovation in the pharmaceutical sector.
Building on the long-standing cooperation between FDA and EMA, further alignment of regulatory processes and procedures can reduce redundant testing and optimize deployment of limited regulatory agency resources.
But advancing on regulatory convergence is not enough: trade agreements like TTIP must uphold the highest intellectual property (IP) standards to protect and promote innovation and the economic growth it supports. The value that IP industries bring to the EU economy is unquestionable: 39% of EU GDP, one third of EU jobs and 90% of EU exports, according to the latest EPO-OHIM report.
TTIP can provide the opportunity to underscore the need to promote high-level standards in trade agreements; encourage cooperation of patent offices towards a grace period; provide for effective pediatric incentives and enhanced patent enforcement. To foster future competitiveness, both EU and US IP systems should be open to further adaptation and alignment in order to incentivise research into unmet needs.
TTIP can also help underscore the importance of pricing and reimbursement systems that reflect the full value that biopharmaceutical medicines can bring to patients and society at large. This includes the value of allowing patients or caregivers to return to work, and impacts on wider health care system efficiency. An annex on market access principles is critical for ensuring patients rapidly gain access to new treatments, and to allow the industry to maintain and grow direct and indirect employment.
TTIP can greatly benefit patients and help the industry in Europe to continue to be a driver for scientific progress and improved health outcomes.1