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Country Perspectives: Germany

This post is the first in a series featuring Lilly’s people from across the EU, in which we explore the state of healthcare in their countries, the EU elections and their implications, and more. Today, we have 5 questions with Dr. Gerd Kraeh, Senior Director of Government Affairs at Lilly Germany.

1. Tell our readers about Lilly in Germany.

Lilly has been in Germany for well over 50 years. Our first office opened back in the 1960s, and we are now based in the small spa town of Bad Homburg. Being a biopharmaceutical company, our main goal is always to bring first in class or best in class medicines to German patients. We also prioritize partnering with other organizations with shared goals. In Germany, for instance, we launched a partnership initiative called “Diabetes@Work” in 2013 in partnership with labor unions, sick funds, doctors, and local companies. We are aiming to push diabetes higher up the political agenda by providing new and practical ideas for prevention and care, specifically in the workplace, but also in daily life. Helping to pave the way for digital care solutions for people with diabetes will be one of the top priorities, through methods like connecting smartphones with insulin pumps. But connected solutions need political support. We have also launched Oncology@Work where we work with a number of like-minded organizations like the German Cancer Society and other local patient support groups. The initiative focuses on helping cancer survivors get back to work. Cancer sufferers and survivors often find it difficult to return to work, not helped by inflexible working conditions and limited support from social security providers. We want to address barriers to social participation caused by cancer, and to push the issue higher up the policy agenda – where it belongs.

2. What are the main issues that are affecting your business in Germany?

For our industry, Germany is an absolute key market. It’s the 4th biggest market for biopharmaceuticals in the world, and the biggest in Europe. The biopharmaceutical industry has been very resilient, remaining stable and avoiding job losses even during the height of the economic crisis, and growing since then, providing 112,475 high-skill jobs across Germany (Source: EFPIA, 2016). We do face some challenges with the Pharmaceutical Market Reorganization Act (AMNOG), which was introduced in Germany in 2011. AMNOG assesses new medicines and treatments after they have already been approved by the European Medicines Agency (EMA) and are available for the German patients. Companies have to submit a HTA dossier so that the new medicine or treatment can be compared to what is on the market at the moment. Based on this outcome, the medicine receives an added benefit classification – or not – which determines the price of the drug and its reimbursement. This process takes a year after the drug has first appeared on the market. The challenge for industry is the resource-intensive nature of AMNOG. Over several months, we are required to go through dozens of procedures. Moreover, the outcome of the benefit assessment does not necessarily meet real-world evidence and healthcare needs in daily life, but often focusses on formalistic and technical procedures that are not in line with patient needs. We are hoping the process can at some point become simpler, more transparent and mirror actual requirements of patients’ needs more effectively.

3. How would you rate patient access in Germany to new and exciting innovations?

When it comes to access, we are really lucky in Germany. Access to new medicines is super fast, usually just a few weeks or months after EMA approval. According to  EFPIA’s Patient W.A.I.T. indicator (WAIT: Patients Waiting to Access Innovative Therapies), Germany ranks 2nd in rate of availability (number of medicines available) and 1st in length of market access delays (the average time between marketing authorization and patient access). This obviously benefits patients, who have fast access to a wide range of medicines. We expect access to remain excellent in Germany, although there are a couple of concerns. For example, restrictive reimbursement policies in Germany due to AMNOG may cause delay or even withdrawal / non-disbursement.

4. What is Lilly Germany looking for in the next EU elections? 

More than anything, to ensure that policy-makers help us maintain – or hopefully even improve – current levels of innovation. Our industry invests a higher percentage of its income on R&D than any other in Europe.1 At Lilly, our R&D investment as a percentage of sales is nearly 1in 4 Euros. We do so because Europe is a competitive and attractive place to invest! We have strong market access provisions, a vibrant talent pool in science, technology, engineering, and math (STEM), complimentary technical partners like universities for clinical studies AND very importantly, we have intellectual property protection and incentives that mean our investments are safe. We are concerned about the pressures on the EU’s IP protection system. If IP was eroded, it would mean companies in our sector would have to reconsider whether Europe remains a viable place to invest. Even more so than in many other sectors, IP is the lifeblood of our industry! Touching IP in the end means putting progress and innovation for patients at risk. Another topic that is close to my heart, and which I am hoping can be raised to the EU level, is the improvement of care for people with Alzheimer's disease. Most people with Alzheimer’s want to stay in recognizable surroundings for as long as possible, usually with their families. Lilly has been an active partner in an initiative called “Dialogue Forum Dementia”, working with sick funds, medical specialists, research institutes, and patient advocacy groups to share best practice and engage with policymakers. We all know the burden and hardship to find a breakthrough medication that will help patients and their families to lead a better and healthier life. But despite setbacks in the past we are working hard and investing further in Alzheimer’s research.

5. Looking into your crystal ball, what are your hopes for healthcare in 10 years? 

Far too many diseases can still not be cured or managed. But new pathways and technologies offer hope of finding treatments that can slow or even stop them. I long for a future where cancer is no longer lethal, but is a chronic condition that can be managed. That is my hope, and I think it can be achieved in the next 20 years. Digital health is a big part of the future picture. Even now, diabetes patients live far better lives than before using tools like smart insulin pumps for continuous and transparent glucose monitoring. Future advances will probably make diabetes treatment almost unnoticeable. Big data will also spur advances in diagnosis and individualized therapies. And patient engagement and empowerment will be formalized! We are talking about it a lot now, and it’s moving up the agenda, but in future, it will be reality: patient preferences and needs will drive all innovation in healthcare.


Footnote
1. Source: The 2016 EU Industrial R&D Investment Scoreboard, European Commission, JRC DG RTD
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