The True Believer: An Interview With New IFPMA Director General Thomas Cueni 08/05/2017 by Catherine Saez and William New, Intellectual Property Watch 2 Comments Share this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) IP-Watch and its Health Policy Watch are non-profit independent news services and depend on subscriptions. To access all of our content, please subscribe here. You may also offer additional support with your subscription, or donate. The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) has long been at the centre of global public health policy in Geneva, representing industry from around the world. Now at a critical moment of change in global policymaking, a new leader, Thomas Cueni of Switzerland, has taken over, starting in February 2017. Intellectual Property Watch recently sat down with him to discuss his views and vision going forward, and discovered his thoughtful pragmatism and diverse background which promise to open an ambitious new era for the association and global health policy. Thomas Cueni, Director General of the International Federation of Pharmaceutical Manufacturers & Associations. Genève février 2017© Nicolas Righetti / Lundi13 Intellectual Property Watch (IPW): Congratulations on your new post. Why did you decide to come to IFPMA, what in your background led you to this position, and what do you hope to accomplish? Thomas Cueni: This is an exciting time to be asked to take on the leadership of the organization representing the international biopharmaceutical industry because we are in an era of change. What prepared me to come to Geneva? I have not only argued for the value proposition of the industry in Switzerland for more than 25 years, but I have been involved throughout all those years in shaping the industry’s policy approach at both European and global levels. When called to assume leadership of IFPMA, with a mandate to strengthen the voice of the research-based biopharmaceutical industry in Geneva, I felt it was the right time — going back to my roots as a Swiss diplomat, I had always been engaged in multilateral diplomacy. The industry needs a strong voice of the industry, since we are called upon to justify the innovative pharma business model. We are being challenged to show the value medicines and vaccines bring to society. Let’s not forget, 10 years ago many people were talking about pharma pipelines not delivering, threatening “patent cliffs” and predicting the end of the blockbuster medicines. Fast forward to today, and we are looking at more than 7000 medicines in development, many of which are the result of breakthrough R&D. The innovative biopharmaceutical industry can boast not just quantity of new medicines and vaccines, but also quality. This current depth in quality of innovation is important. In the past, I would not quarrel with certain criticisms of too many “me too” medicines. I agree that in some areas, there have been drugs developed that did not differentiate sufficiently. The current return to breakthrough innovation shows that the market has adjusted and is rewarding real innovation for unmet medical needs. Today, if you are too late and you come in to market at 7th, 8th, or 9th, let alone 15th or 16th, it does not pay. In contrast, if you can demonstrate significant added therapeutic value – whether enhanced efficacy, better safety, or improved quality of life, you are likely to obtain a premium price. Whatever it is designed to treat, new medicines must have clear distinction: the 25th beta-blocker obviously does not have that. But talk that the biopharmaceutical industry does not have a strong pipeline, and is not coming up with innovative research, is outdated. Talk that the biopharmaceutical industry does not have a strong pipeline, and is not coming up with innovative research, is outdated. – Thomas Cueni Examples of industry delivering on its pipeline are the recent great advances in oncology treatment or rheumatoid arthritis. HIV/AIDS has been turned from a deadly into a chronic disease, and there is today a rich expansion of treatments for rare diseases. Twenty years ago, if you were diagnosed with an ultra-rare disease, it was just bad luck. Nowadays, many drugs can treat these rare diseases. Advances in science and incentives like the ones contained in the Orphan Drug Act have worked. The biopharmaceutical industry is still extremely competitive, but today there is a much more collaborative approach to research. In some areas, for example, the development of immuno-oncology combinations, you have cross-company cooperation. In other areas, we are seeing many more public-private partnerships, in particular in areas where the typical business model is not working. I strongly believe in the competition-driven business model based on strong protection of intellectual property, but in areas like neglected tropical diseases or anti-microbial resistance, we must think out of the box and be open to new kinds of partnerships. The Innovative Medicines Initiative (IMI) of the European Union, collaborations such as the GAVI Alliance, the collaboration in Geneva on Neglected Tropical Diseases (as celebrated at the recent NTD Summit), the Medicines for Malaria Venture (MMV), the World Intellectual Property Organization Re:Search, are all examples of successful collaborations. The biopharmaceutical industry has really opened up to new ways of working together with the academic community and public sector – that is not only exciting, but also good for global public health. IPW: What is the incentive for a company to take the initiative to collaborate and participate in these initiatives that are needed to address diseases that fall on the side of profitability? Can the private sector be the one to drive those kinds of initiatives? CUENI: I believe strongly in a competitive research model where innovation is supported by strong protection of intellectual property. Successes are rewarded and not failures. This business model based on IP rights and competitive markets has delivered great medical breakthroughs for patients and society. But, there are areas, and the NTDs are one example, where there is no functioning competitive market, where we all need to think out of the box, where you need to think beyond the classic business model. And there are areas, such as orphan drugs or AMR, where you can create market-based incentives to make it attractive. IFPMA doesn’t need to be loved, it wants to be respected. What is special about the biopharmaceutical industry? Companies are very much aware of societal expectations. Corporate social responsibility is not just a buzzword. To a significant extent pharmaceutical companies derive their license to operate from delivering value to society at large. Clearly, they have to be profitable to invest in R&D for innovative treatments, but they are also expected to act in socially responsible ways. As a trade association leader, I always felt that I had a dual job: on the one hand, I have to stand up and defend the value proposition of our industry, on the other I have to build bridges and demonstrate that the biopharmaceutical industry is part of the solution and not the problem in improving the health of the people in developed and developing countries alike. When you look at what is hindering access to medicines, what are the barriers, a lot of them are systemic. For example, a couple of years ago there has been a great deal of soul-searching around the Ebola epidemic. But let us not forget that neither the 2003 report on Priority Medicines for Europe and the World, commissioned by the World Health Organization and the Dutch Government, nor its 2013 sequel mentioned Ebola as a priority disease since most experts considered that an outbreak – in contrast to a major influenza pandemic – could be easily contained by classic public health measures such as isolation of patients. Things did not unfold in that way because of health systems failure in affected countries. The interesting thing is how fast a vaccine was produced — through public-private collaboration and the involvement of regulatory agencies — once the crisis was fully realized. If there had not been some vaccines in the pipeline, this result could never have been accomplished in a manner of months. Today, the Coalition for Epidemic Preparedness Innovations (CEPI) initiative, the WHO PIP Framework (Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits) show that the biopharmaceutical industry continues to contribute to novel solutions. IPW: You are bringing a message to say industry is not a problem, being part of the solution, you are not coming in with an idea to change the existing business model for the private sector, and research and development, and accessibility and affordability? CUENI: No, the existing business model works. There is no better incentive for coming up with innovative treatments than competitive research, strong intellectual property protection, and the reward for the successful innovator. But in tackling the health care challenges of the developing world we need to leave our own “comfort zone” and collaborate with others, be it in engaging on health systems reform or in partnerships to bring medicines to people in resource-constrained settings. For example, IFPMA is now hosting the secretariat of an initiative called Access Accelerated, launched earlier this year. Access Accelerated brings together 23 global biopharmaceutical companies, teaming up with the World Bank, the Union of International Cancer Control (UICC), and Boston University in an effort to demonstrate that you can really make significant progress in addressing the NCD epidemic through cooperative action. Access Accelerated has several components: pilot country systems development in the area of non-communicable diseases (NCDs), a multi-stakeholder best practice exchange platform with the World Bank, regulatory harmonization in Africa, a World Bank project in partnership with the Bill & Melinda Gates Foundation (BMFG), the partnership with the C/Can 2025 Initiative of the Union for International Cancer Control (UICC) in five pilot cities in developing countries, multiple access initiatives of the 23 participating companies, and, finally, the willingness to submit the industry’s efforts to the scrutiny of Boston University, which has been tasked with establishing a metrics framework for measuring progress in a transparent way. IPW: You have a very rich background. What is your style – more an analytical or an action-oriented person? How would you define your style? CUENI: I am excited by the intellectual debate that is unfolding in Geneva. I’ve always been interested in the brainstorming of an association job and the challenge of bringing people with different backgrounds and thoughts together. This is highly stimulating. However, the reason why I never thought of becoming an academic myself is that I am very pragmatic and solution-oriented. At the end of the day, while I love the intellectual interaction, I am interested in actions and getting results. IPW: Some see discouragement with a “Geneva syndrome” where they feel there is a little too much consideration for anti-IP rights, too much impractical thinking on how the world really works, and out of touch with the rest of the world. What are your thoughts on this? CUENI: As you may have noticed, I am quite willing to call a spade a spade. It appears to me that there is not one but at least two Genevas. On the one hand, you meet people of whom you think, ‘Oh God, are we back to the 1960s, 1970s?’ as if the world has not moved on, very much in a dogmatic trench warfare. But then, you see an opening with institutions and organizations like DNDi [Drugs for Neglected Diseases initiative], the Medicines Patent Pool, the WIPO Re:Search, the Medicines for Malaria Venture, the London Declaration on NTDs, the Bill and Melinda Gates Foundation, the multiple public-private partnerships, including for product development, and there is a sigh of relief. The world, including the industry, has moved on. Personally, I consider it boring to talk just to the converted, and industry has been quite good at talking among itself. My colleagues at IFPMA have been reaching out and creating partnerships for quite a number of years. We need to build on this and continue to stimulate debate and also cross bridges. I am quite willing to stand up and argue the points I make because I think one of the assets I bring to IFPMA is that I am a believer. I believe in what I say. I am not a hired gun. However, we probably need more conversations with people who are critical about parts of what we do and we also need to be prepared to reflect on areas where we may need to adapt and change. I am quite willing to stand up and argue the points I make because I think one of the assets I bring to IFPMA is that I am a believer. I believe in what I say. I am not a hired gun. IPW: There is a problem of high drugs prices affecting developing and developed countries. Do you have a vision to address the problem? Do you have a solution up your sleeve? CUENI: I do believe in the value proposition of our industry. When we look at how new medicines have transformed the treatment of many diseases over the last 20 years, it is quite remarkable that spending on prescription medicines in vast majority of OECD countries has been stable around 10-15% of total health spending. Having said this, I am fully aware of the concerns around the issues of pricing, in particular, of new medicines, and we must be open to addressing the questions raised. However, the debate should be fact-based and balanced. It is necessary to break down silos and introduce whole system thinking, e.g. on waste in the system and efficiency on health spending. In our sector, I do believe that discussions are necessary on paying for outcomes, for performance, for example when you look at the challenge of paying for combination products in the field of immuno-oncology. The challenge is that health care systems work in silos: doctors, nurses, medical devices, drugs, and that is static. These are all fixed with annual budgets that are not dynamic. I can understand why some prices are questioned, and that there are debates about what is a fair price is. Obviously, we also can’t ignore the issue of affordability for developing countries. However, I am apprehensive about simple solutions. And we need to keep the debate in perspective. The fact is, for example, that aggregate spending on all oncology drugs in Switzerland represents just 1 cent out of every franc spent on health care. In Switzerland, six times more is spent on tobacco (the leading cause of lung cancer) than is spent on all oncology drugs together. I can understand why some prices are questioned, and that there are debates about what is a fair price is. Obviously, we also can’t ignore the issue of affordability for developing countries. However, I am apprehensive about simple solutions. IPW: How would you measure your success at IFPMA on objectives that you would like to be reached? CUENI: I think it is clear: IFPMA doesn’t need to be loved, it wants to be respected. Respected for helping develop new partnerships, respected for helping our medicines reach millions more people in developing countries, but also respected for standing up and firmly arguing the value proposition of our industry. IPW: Are any areas that you think need attention at IPFMA, as you inherited the reins of IFPMA? CUENI: I am lucky that I can build on strong foundations. For example, IFPMA has been pioneering work on ethics and business integrity. Compliance with codes is something that is very important and will continue to evolve. The recently launched Access Accelerated Initiative with UICC and the World Bank is potentially a game changer as it is a really bold initiative. I would like to see IFPMA be more visible and help our ideas gain more exposure. IPW: What do you see as key IP issues? At an event early in March you said that transparency in prices was in fact not a good idea, could you elaborate on this? CUENI: There are in fact two issues on transparency, first about transparency of costs and second, transparency of prices. I see in the report of the UNHLP on Access to Medicines a call for cost-plus pricing. You have the cost of R&D, you have the cost of manufacturing, the cost of marketing, the cost of distribution, and then you add the margin and you talk about what is a fair margin. This approach is deeply flawed. History has shown that cost-plus pricing has not led to breakthrough innovations. Instead, it incentivises less risky, safe innovative paths where there is a high chance of success, marginal differentiation, but a decent price and return on investment. Instead, one should reward risk-taking and success, therapeutic added value and not cost of input. This is why the US system which has always been much more reward-driven, benefit-driven, with high reward for high innovation, is very lucrative for the successful innovator, but also very tough for those who fail to reinvent themselves every ten years. Frankly, this applies equally to the biopharmaceutical industry as it does to other innovative industries. As patients or consumers we want to pay for what we get, and not for the potentially inefficient production costs. Cost-plus pricing is fundamentally flawed in an industry, which relies so much on true innovation. I can see why Swiss hepatitis C patients denied reimbursement by their sick funds may want to get cheap hepatitis C medicines from India. But if that happened in a large scale, the system would break down in India. My second point is about the flaws of full price transparency. It is worth recalling the conclusions of a 2008 OECD study about pricing and reimbursement of medicines, which raised the question whether there shouldn’t be less, rather than more, price transparency. Indiscriminate price transparency could go against efforts to make drugs more affordable for those in need, because rich countries were unwilling to pay more than poor countries if they had full access to prices paid by others. This was at that time exemplified by the German Minister of Health, who publicly argued that she was not willing to pay more than Portugal or Latvia, because Germany is a big market, which is buying more and expects to pay less. Looking at the North-South debate, the matter is even more critical. Unless there is a “Social Contract” whereby rich countries accept to pay more than poor countries, price transparency leads to less, rather than more, solidarity. That is one of the challenges of the urge for transparency. I can see why Swiss hepatitis C patients denied reimbursement by their sick funds may want to get cheap hepatitis C medicines from India. But if that happened in a large scale, the system would break down in India. Unless there is a “Social Contract” whereby rich countries accept to pay more than poor countries, price transparency leads to less, rather than more, solidarity. IPW: How do you see the interaction of IFPMA with other actors, such as the WHO, in the context of the PIP Framework and the Framework for Engagement with Non-State Actors, other international organisations, civil society, patients’ organisations? CUENI: We want to be respected for the strength of our arguments but also be seen as constructive, solution-oriented and building bridges. Our capacity to reach out is crucial. IFPMA has an observer status with the WHO as well as the UN system. The private sector and civil society need to be represented, and IFPMA is part of this broad network, operating within clear rules of engagement to avoid conflicts of interests. I do see the FENSA rules playing their part in creating transparency and preventing conflict of interests. But at the end of the day, cooperation and partnership of the UN system with the private sector is vital if you want to get results and deliver more medicines and vaccines to the patients who need them. IPW: Do you think industry should have more elevated relationships with WHO than civil society because they have to be at the table? CUENI: We are part of the overall Geneva ecosystem. I do believe we have some unique features in terms of our R&D skills, our knowledge of developing new therapies addressing unmet medical need, and global outreach, as demonstrated recently by the biopharmaceutical industry’s ability to respond quickly to a crisis like Ebola but also living up to the London Declaration on NTDs. I also believe that we have a unique role in addressing the challenge of antimicrobial resistance. Therefore, I do believe that we must have a seat at the table, along with civil society. IPW: Thank you. Image Credits: IFPMA Share this Story:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Related Catherine Saez may be reached at firstname.lastname@example.org.William New may be reached at email@example.com."The True Believer: An Interview With New IFPMA Director General Thomas Cueni" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.