Value of the Industry
The pharmaceutical industry is important to European competitiveness. In 2011, Europe remained the second largest market for pharmaceutical sales. Meanwhile, the presence of a highly-skilled workforce and robust framework for the protection of intellectual property rights (IPRs) are key factors in the industry investing €27.5 billion in R&D in Europe last year. The pharmaceutical industry is one of few sectors to contribute positively to the EU’s trade balance. Its trade surplus of €48.3 billion in 2011 was the highest among high-tech industries.
However, it is clear that both the pharmaceutical industry and the European economy are facing challenges. These range from the increasing pressure on public purses to ongoing regulatory hurdles. Add to this the rising costs of R&D in Europe and competition from emerging economies vying for R&D investment. The geographical balance of the pharmaceutical market – and ultimately its R&D base – is likely to be re-weighted towards emerging economies. This is a positive development if it is paralleled by a progressive alignment of trading conditions. However, 2011 saw a continuing trend of protectionism across these emerging markets, with many measures having a disproportionate impact on foreign companies.
The support of the EU’s external trade agenda is key to ensuring Europe’s growth through market access for innovative medicines from our industry and promoting a level playing field from a regulatory perspective vis-à-vis increasingly strong trade partners. In order to promote innovation, bilateral negotiations between the EU and pharmaceutical high growth markets should also be directed at ensuring that intellectual property rights (IPRs) are adequately protected in these countries.
Key to ensuring patients have access to potentially life changing new treatments, are efficient procedures for the pricing and reimbursement of innovative medicines. The review of the Transparency Directive in 2012, presents an opportunity to make decision-making by member states in pricing and reimbursement of medicines more efficient. Not only by shortening the time it takes for decisions to be made, but also by setting adequate standards for P&R processes and ensuring a proper enforcement of the rules. The goal must be to get the necessary medicines to the patient as quickly as possible. Moving forward, pricing and reimbursement processes will also need to adapt to take account of the “new science” such as personalized medicines, with initial pricing and reimbursement decisions being flexible and updated. In relation to antibiotics, it may be necessary to go one step further and think about new ways of incentivising innovation which do not rely on volume sales.
Given the varying levels of economic development inside the EU, there is a need to have differential pricing of medicines to ensure access to innovative medicines in poorer European countries. Many of the required changes can only be achieved through a more coherent and integrated approach which replaces current highly inequitable practices, such as international referencing, with other more sustainable means of guaranteeing value for money for Member States.
Especially in difficult economic times, the pharmaceutical industry’s dealings with national authorities responsible for pricing and reimbursement should be based on clear principles of mutual respect and transparency. Differences in approaches should be acknowledged but should not stand in the way of dialogue and collaboration, and the legitimate viewpoints of all stakeholders should be acknowledged from the outset. Discussions should be guided by the key questions of availability, accessibility and affordability of medicines.
More and more member states have been adopting Health Technology Assessment (HTA) methodologies as a key evidence-based support to healthcare decision-making. This has led to increasing diversity of systems throughout Europe. European collaboration on HTA can promote good practice and improve efficiency by reducing unnecessary duplication, which is why industry supports the setting up of a permanent European network connecting HTA agencies by 2013. This is also an opportunity to streamline clinical evidence requirements to support the separate processes of medicines regulation and HTA.
In these tough economic times, researchers, decision makers and politicians are wondering what the contribution of health to the economy is, and whether healthcare expenditure caps make sense on economic grounds. Several studies have been released which try to understand the relationships between health and wealth,. These aim at challenging the traditional paradigm "health = cost" with "health = wealth", and demonstrate that increases in health spending can be justified purely on economic grounds. However, there is a lack of European data and an urgent need to explore new measures to assess health improvements and a broader concept of populations' wealth that goes beyond GDP.