Has the European Union done its homework when it comes to supporting the competitiveness of European business? It is no secret that we have begun to slip behind other regions of the world.
Indeed, we are slipping behind. The data shows how dramatically the situation has changed over the last 20–25 years. In 2002, the United States spent €2 billion more than Europe on research and development in the pharmaceutical sector. Today, this imbalance has grown to €25 billion. This is the United States' advantage in terms of annual research and development spending. It shows how quickly we are falling behind America. It seems that we, as the European Union, are slowly beginning to realise that we need innovation in order to remain competitive globally, and we are starting to develop solutions that are designed to strengthen this competitiveness. I am an optimist by nature, so I look at these efforts with a sense of hope. However, we certainly need good, in-depth dialogue between the public and private sectors. We also need more solutions that ensure stability and predictability in terms of the investment climate. The first signs of change are already visible, such as the European Commission's announcement of the Biotech Act. We must be open to new biological medicines, cell therapies and gene therapies. These are solutions that address the most important unmet needs of patients. They are also essential for remaining competitive.
We are unlikely to close the €25 billion funding gap in research and development. So what tools can we use to compete with the United States?
I think that, first and foremost, we need to let companies act. However, in order for them to do so, we must remember that this is an industry that sometimes spends up to 25% of its revenue on research and development – more than the big IT sector. Companies need the right conditions to create a favourable ecosystem for their activities. First of all, we need science and business to work together. We know that the United States is ahead of us in terms of university development. The Shanghai ranking shows that eight of the ten best universities in the world are American. They are the ones that generate a large part of innovation. As an industry we want to support universities in their further development, but we need the best possible partnership between science and business. The second issue is the predictability of the legal environment. I am talking here about both the European and national levels, because many issues are still regulated locally. A good example is the amendment to the Reimbursement Act. Stable regulations and predictable demand for innovation may make companies more willing to invest in Poland. It should be remembered that the innovation industry accounts for nearly 70,000 highly specialised jobs, and we wish there were even more. However, competition for investment is greater today than ever before. Many companies announce new projects in the United States, which further increases pressure and risk.
What else?
The third element is the protection of intellectual property rights. The 25 per cent of revenue invested in research is, in fact, an investment in intellectual property rights, which are at the heart of our business. The development of a single new medicine costs nearly $2 billion. If we do not provide effective, efficient and rapid patent protection, it becomes very difficult to attract investment. We therefore call for medicines to be protected until the patent expires. It is clear that generic drugs are an important part of the system and should appear on the market, but only after the patents have expired. There should be no situations, as unfortunately sometimes happen in Poland, in which generic drugs enter the market before the patent expires and even receive reimbursement although the patent is still in force.
What is the response of pharmaceutical companies in such a situation?
Our response is to take legal action to protect our rights. In most EU countries, such protection is granted within a few weeks. In Poland it takes months. It can take anywhere from 6 to 24 months. If protection is not granted quickly, both companies and state authorities operate in conditions of uncertainty. For us the matter is clear: we have an important patent and we expect that when someone infringes it, the matter is resolved immediately, taking into account the arguments of both sides, of course, because that is the foundation of the legal system. It is extremely important that the perspective of both the innovative company and the generic company is considered. However, there are examples of countries – such as Spain or, closer to Poland, the Czech Republic – where, after hearing both sides, decisions on protection are issued within three to four weeks. If the patent is strong, the generic company is obliged to cease distribution that infringes the property rights.
