Pharma innovation – giving value for value received

Andrew JennerAndrew Jenner

The Chief Innovation Officer of the company that invented the way crisps in a tube are packed (rather than the wasteful packages full of air) coined the phrase: “What we’ve done to encourage innovation is make it ordinary.” The bio-pharmaceutical scientists and researchers deal with more complex issues than the humble potato crisp, such as how the human body can be helped to fight off diseases that are constantly evolving. But what we do have in common is that we don’t take enough time to remind ourselves of the impact of medicines and vaccines on our lives and the ability pharmaceutical innovation has to transform societies, making the unimaginable a reality.

Although innovating new medicines and vaccines is getting harder, and there is plenty of scope for new inventions, be it a medicine to cure the common cold or a vaccine to protect from contracting AIDS; there is plenty to be optimistic about. Every year, the US’s Food and Drug Administration approves on average 25 new drugs. In the past decade, over 340 new drugs have been approved to treat different chronic and non-chronic diseases including cancer.

While “understanding human needs, is half the job of meeting them”, I would also contend

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that understanding the value of innovation – the clinical and economic value, the future promise and the value of the legacy past medical breakthroughs is half to job in recognizing its contribution to improving global health.

THE VALUE OF INNOVATION

It’s pretty well established that innovation or the process of translating an idea into an approved new drug takes anywhere from 10 – 15 years and costing at least a billion dollars. Such cost comes with some rewards as it supports high value jobs, helps strengthen local communities and the world’s economies alike. Yet it also carries potential risks: failure in proving safety of the new product for example.

Two recently published studies this year reveal that the value of innovation can be considered through two dimensions: the clinical and the economic.

Clinical value

The clinical value is highlighted in a study carried out by Charles River Associates earlier this year, Assessing the value of biopharmaceutical innovation in key therapy areas in middle-income countries.

This study reveals that in the case of rotavirus for example−the most common cause of severe diarrhoea among children in both industrialized and developing countries, claiming the lives of around 450,000 children every year, CRA compared the value that two recently-launched vaccines yielded in Brazil and Australia. The major benefit seen in both countries was a direct drop in hospitalization costs, but in Brazil they also witnessed a major decline in related mortality rates. So obviously both benefitted from these innovations, but given the nature of the disease burden the added value was greater for Brazil.

Economic value

The economic value is evidenced in a recent study carried out by WifOR, “First steps towards measuring the economic footprint of the industry”, the main key findings were that the pharmaceutical sector has roughly generated $441 billion worldwide in direct gross added value, equivalent of the economic strength of Argentina alone for 2011. Another value no less important is that the industry employs some 4.2 million people worldwide, the equivalent of Austria’s labour force which is huge.

There is no doubt that innovation in this sense is vital for the economic development of a given society through a productive workforce, through the ability of children not only to survive scourges of diseases but also to grow and learn making their way into the school system and the ability to later on contribute to the community, to be able to undertake economic activity and attract investment. In a nutshell, innovation is not only saving people’s lives and making them healthier, but also generating high-value opportunities the world needs.

The legacy of the therapeutic innovation

The top 20 companies invest on average 20 percent of their revenues in R&D to develop new medicines and vaccines. It is this investment and drive, year on year, which has given the world the legacy of medicines available to treat the major illnesses, such as diabetes, cancer, heart disease, asthma, HIV/AIDS. The recipes for producing the vast majority of the basic treatments (we call this first line medicines) are now produced by generic companies in India, China, South Africa and sold around to both the developing and developed world. Indeed, 80 percent of generic medicines are sold to the US and Europe. That is the legacy of our innovation.

It’s time to agree on Universal Health Coverage guiding principles

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With 1 billion people lacking access to basic health care and more than 2 billion people lacking regular access to essential medicines, governments are increasingly placing emphasis on the promise of universal health coverage (UHC). UHC has become an increasingly salient issue for developed and developing countries alike in the context of the global economic crisis, increasing health care demands, and still unmet medical needs. There is increasing recognition that providing quality universal health coverage is an investment in socio-economic well-being and a key contributor to the wealth and economic productivity of countries. As negotiations on a new set of UN Development Goals progress over the next 18 months, 2014 is a crucial year for global health and offers an opportunity to inject a new vision for health that spans across the health systems and, beyond, across sectors.

The innovation pharmaceutical business is one among many actors in the global health community that has in its power to bring solutions for a healthy world – solutions that make a difference to patients, to communities and society.  However, translating the lofty goals of UHC needs in our opinion shared guiding principles to galvanize efforts of all those involved in global health in drawing up well-designed policies. Drawn from our technical knowledge and experience in providing access to high quality health solutions, we have identified eight guiding principles in the areas we believe our industry can contribute.

  1. Equitable Access –All people should have equitable access to essential health care services.
  2. Efficiency – Health systems should use resources effectively and efficiently.
  3. Quality – Health systems should guarantee access to quality infrastructure, service and care.
  4. Inclusiveness – Transition to and implementation of Universal Health Coverage should include engagement of all relevant stakeholders to maximize patient needs.
  5. Availability – Essential health services and products should be available to all those who need them.
  6. Adaptability – Diverse approaches should be encouraged to facilitate UHC based healthcare financing and delivery.
  7. Choice - Health systems should preserve patient choice in health care services and delivery.
  8. Innovation – Society should encourage investments in R&D across the spectrum of prevention, diagnostics, treatment, care and support.

While every country is unique and tailored approaches will be required, there are common challenges and opportunities faced by countries at all stages of UHC. It is with this in mind that we have drawn up eight guiding principles that we think stand up to the test of such diversity, and can help inform the design of global UHC policies.

The process leading to the final intergovernmental decision is complex, but we believe the business community and the biopharmaceutical industry in particular have an unprecedented opportunity to contribute to this debate and present the vision and the value that industry brings towards achieving healthier societies around the world. So, as countries work toward UHC, these principles may offer guidance to policy makers, industry, and other stakeholders who seek to improve health care and meet the health needs of all citizens.

Please tell us what you think of these principles as we move forward in partnership to improve patient access to quality medicines.

Support Fight the Fakes on Thunderclap!

In a month we will celebrate “World Malaria Day” (25 April)! The Fight the Fakes campaign would like to mark the progress made in the control and elimination of malaria with a ringing Thunderclap!

Malaria is a disease that can be prevented, diagnosed and treated when using the right medicines. The past decade has seen an impressive mobilization of resources and political will to reduce worldwide suffering from this sickness:

50 COUNTRIES are on track to reduce malaria cases by 75% in 2015!

The strides achieved so far have in large part rested on raising awareness and community-level actions to provide treatment and nets for prevention.

Let’s keep fake

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medicines from undermining these efforts!

Fact: 30% of the drugs used to treat malaria worldwide are fake medicines.

So what does this mean for you and me? When pills of chalk, salt or even poisons are given in the place of lifesaving medicines, the consequences are devastating for individuals and their communities.

Fact: Every 5 minutes a child dies of malaria because of taking fake medicines.

Please join us in adding to the awareness by letting the people know about the dangers of fake medicines. It only takes a minute to sign up and support our Thunderclap!

Chasing away the Monday morning blues

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Life just always seems a bit tougher on Mondays. One good way to blow away the blues is to concentrate on projects that reward you with quick wins followed by the reward of some “me time”. That’s why, when I can, I try to fit in an hour of sport instead of grabbing a longer lunch. It breaks the day and gives me a boost… and keeps the doctor away!

I was thinking about this when last week I was invited to speak at the launch of a new study on corporate healthy lifestyle programs in Moscow. Research has shown that in Russia, people place great value in their health but few take action (you might be able to apply that to many countries), with the resulting health problems that come from smoking, unhealthy diets and lack of physical activity. But there is some good news. This new study showed that employees want their companies to help them be healthy and two in three Russian companies appear to be up for the challenge, not least because a healthy workforce is a more productive one.

First study of its kind in Russia explores corporate wellness programs

The study assesses the experience in setting up and implementing corporate healthy lifestyle programs in Russian companies, identifies employee attitudes and their preferences for the programs implemented. The study was commissioned by our Russian colleagues at AIPM and ourselves at IFPMA and prepared with support of the National Research and Development Center for Preventive Medicine and the Russian Union of Industrialists and Entrepreneurs (RSPP), in partnership with the Ministry of Health of the Russian Federation.

46 state-owned and private companies representative of a range of the sectors participated, including Gazprom, Lukoil, United Breweries Heineken, IKEA, Russian Railways, Megafon, Rostelecom, to name a few.

Top line findings show employers and employees are ready to get healthy

The survey determines that two out of three employers were ready to support their employees’ health. The most common types of programs employers currently provide their employees include arranging for sports events, vaccination and hot meals. Employees unanimously welcome company programs that support sports activities, subsidies and discounts for health nutrition and health screening.

The study shows that there is significant scope to expand healthy lifestyle programs in the workplace to fully reap the benefits of a healthy workforce. It also provides a blueprint for successful programs and encourages other employers in Russia to put in place healthy lifestyle programs. After all, these programs are not only beneficial for employees; they are also in the interest of employers and have been publicly supported by World Health Organization (WHO) and International Labour Organization (ILO).

Multiplier effect as employees bring the health messages into their homes

Workers that commit to a healthy lifestyle will likely influence their families and friends and will be more receptive to government prevention campaigns, which may be the key to helping tip the balance and lead to healthier reflexes among all of us.

We have witnessed this spill over effect within the pharmaceutical industry, where more than half of the prevention programs that our companies carry out for their 1.1 million employees reach wider network of relatives.

Health across all government policy making is a force for good

Government actions in support of corporate healthy lifestyle programs can make a dent in the tragic and escalating trend of deaths and disability through NCDs. Even in the case of workplace wellness policies, a “whole-of-government” approach encompassing coordinated actions in areas other than health and at different geographical level is

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needed.

Prevention, even through physical activity, is the best value for money in curbing NCDs. Corporate healthy lifestyle programs are yet another way to empower and help us turn the tide of apathy and change behaviours.

We all know, at a personal level that it is difficult, but if we all get behind it, there is a chance we will succeed in ultimately saving and have better lives. If you are not convinced, you can still see it as a nice escape to the Mondays’ blues!

World Cancer Day 2014: Hand in hand to debunk cancer myths

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Today, February 4th is World Cancer Day. This annual event is the ideal opportunity for millions of people to raise the profile of cancer around the world. The Union for International Cancer Control (UICC) and its 800 member organisations across 155 countries seek to press the world’s media to place cancer on their agendas and across their global news networks.

UICC, its members and partners such as IFPMA use World Cancer Day to present the facts about a disease which many people do not know about and to dispel the many myths and misconceptions around cancer. As CEO, I have seen first hand how misinformation or lack of information about cancer can make detection and treatment even more challenging for people. That is why, this year we seek to “debunk” four myths, following the success we had addressing four other myths in 2013:

  1. We don’t need to talk about cancer
    The truth is that whilst cancer can be a difficult topic to address, particularly in some cultures and settings, dealing with the disease openly can improve outcomes at an individual, community and policy level.
  2. There are no signs or symptoms of cancer
    In fact, for many cancers, there are warning signs and symptoms and the benefits of early detection are indisputable.
  3. There is nothing I can do about cancer
    The truth is that there is a lot that can be done at an individual, community and policy level, and with the right strategies, a third of the most common cancers can be prevented.
  4. I don’t have the right to cancer care
    We believe that everyone should have the right to access proven and effective cancer treatments and services on equal terms without having to suffer hardship as a consequence.

A lack of knowledge in the general public is a key indicator of the difficulty we face in addressing cancer today. It results in individuals exposing themselves to risk factors which they are unaware of. It causes people to view cancer as simply fate. It encourages people to assume that a diagnosis of cancer will always lead to death. All of these myths and misconceptions limit our ability to tackle cancer effectively.

World Cancer Day is our annual opportunity to improve the world’s general knowledge of cancer and challenge misconceptions about the disease at an international level.

What are the facts?

  • In the next twenty years the real growth in cancer deaths will take place in low- and middle-income countries – in countries which are least equipped to cope with such an increase in cancer cases.
  • Cancer kills more people prematurely than any other non communicable disease.
  • Globally, more people die from cancer than from AIDS, malaria and tuberculosis combined.
  • Approximately one in three individuals will develop cancer in their lifetime.
  • In 2010, 14.1 million people were diagnosed with cancer and 8.2 million people died from the disease worldwide.

Cancer is already a significant challenge for our generation and it is set to become even more impactful in the next 20 years. New data from the International Agency on Cancer Research (IARC) suggests that cancer cases will rise by 75% to close to 25 million new cases per year over the next two decades.

Please visit www.worldcancerday.org to see what you can do to share information about World Cancer Day, and be aware of the events and activities being run around the world by the member organisations and partners of UICC (www.worldcancerday.org/events-map).

UICC, its members, partners and other globally respected organisations like the IFPMA, work together to reduce the burden of cancer globally on a day-to-day basis. On World Cancer Day we stand together to bring focus to a disease which many people do not want to talk about. Cancer affects everyone in some way and the UICC welcomes all organisations which recognise that they can contribute to improving the situation globally. In this respect, the UICC applauds IFPMA for their stated ambition to improve “health around the world by contributing expertise, building trust, and establishing solutions for global health”. Together we are stronger. 

Cary Adams is Chief Executive Officer, Union for International Cancer Control (UICC). He is also Chair of the NCD Alliance, a coalition of around 2,000 NGOs working on Non-Communicable Diseases, which includes cancer, diabetes, heart and respiratory diseases.

Sharing biotherapeutic best practices: a win-win for all

Fermin Ruiz De Erenchun

In November, I returned from a very productive and interesting trip to Peru, where we hosted a regulatory workshop focused on biotherapeutic medicines.  The reason for my enthusiasm is the very high level of commitment and engagement among health authorities and other experts to cooperate in overcoming national obstacles to medicines access.

At this workshop, the medicines we focused on were biotherapeutics, a class of therapies that offer patients new hope for a variety of common and rare diseases.  These medicines are “manufactured” using naturally-occurring microorganisms rather than by traditional use of chemical synthesis.  This makes biotherapeutics much more complicated to produce– and to regulate! In many cases, the old rules don’t work well for these medicines, which is why our South America-wide workshop, called Biotherapeutic medicines: sharing experiences and best practices, was of such interest to so many experts.

As Chair of IFPMA’s Biotherapeutics Group and a physician, I know the value of these medicines to patients.  This class includes synthetic insulin for diabetes, innovative anti-inflammatories for arthritis, and treatments for hepatitis.  In fact, there are currently more than 200 biotherapeutic medicines available for patients and many more in the pipeline, but until now health authorities have slowly developed new rules for reviewing the regulatory dossiers of these medicines.  This conference was a forum for regulators from around South America, along with experts from the World Health Organisation and Health Canada, to bring their experiences, their lessons in reviewing biotherapeutics before and after approval, and their best practices.

Our hope is that health regulators in South America and beyond will adopt and apply the best practices that make sense to their individual countries.  Much has been said about globalization in recent years – positive and negative – but this event, where countries can learn from one another on what to apply and what to avoid, is certainly a very positive example.  It is a win-win for all involved, especially patients.

To find out more, click here.

Developing a Consensus Framework on Ethical Collaboration with our Partners

Russell-Williams

As developed and developing economies strive to address pressing health challenges in a complex and fast-evolving healthcare environment, collaboration between all partners is essential to ensuring proper delivery of the most appropriate health care for patients worldwide.

Collaboration is defined as the exchange of information, knowledge, experience and diversity of perspectives.  Moreover, collaboration needs to be transparent, efficient and ethical, but also understood by everyone and based on trust.  This can be ensured in part through self-regulatory and voluntary mechanisms such as code of conducts and guiding ethical principles. There are numerous successful examples of these mechanisms.  In fact, each profession that deals with patients governs itself based on its own set of principles toensure quality interactions.

However, there is a growing understanding that a common, health sector-wide set of standards – one that reaches across professions – is desired and indeed needed.   As Chair of IFPMA’s Code Compliance Network, I feel strongly that achieving overarching common principles will serve everybody, particularly patients, by instilling trust.

Along with several partners, we recently launched the Consensus Framework for Ethical Collaboration to address this need.

It is supported by the International Alliance of Patients’ Organizations (IAPO),the International Council of Nurses ( ICN), the International Federation of Pharmaceutical Manufacturers  and Associations (IFPMA),the International Pharmaceutical Federation (FIP) and the World Medical Association (WMA) and is open to other key partners working in life-sciences and healthcare delivery.

The Consensus is based on four overarching principles:

  • Put Patients First
  • Support Ethical Research and Innovation
  • Ensure Independence and Ethical Conduct
  • Promote Transparency and Accountability

Reaching consensus extends the high ethical standards across the health sector and ultimately is essential to enhancing patient confidence and trust in the healthcare system.

Effective implementation of Consensus Framework is a shared responsibility by all parties involved. At the same time we need to look even further beyond to see how other sectors – such as generic medicines and SMEs – can be involved. The current discussions within APEC and specifically the Mexico City Principles For Voluntary Codes of Business Ethics in the Biopharmaceutical Sector can be a good example of how to move forward. Stay tuned to learn more about that….

Fighting Fake Medicines is Everybody’s Business

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In my capacity as IFPMA Director General, I have an interesting vantage point of how the various global health groups in Geneva and beyond – international organizations, NGOs, national governmental missions and industry – collectively tackle a range of global health issues. Collective action has led to important progress on HIV/AIDS, malaria, tuberculosis, neglected tropical diseases as well as vaccine-preventable diseases like polio. There are also advances being made in so called non-communicable diseases through coordinated action by the global health community at large.

One area that could benefit greatly from collective action – in fact, success depends on it – is fake medicines. I sense a growing determination among my global health colleagues in Geneva and around the world to do more to address the low awareness of this crime – and it is a crime against patients and society at large! Until there is adequate attention and action on the prevention, and on the creation and strict application of legislative and regulatory frameworks, we won’t be able to combat effectively this global threat.

While nobody should try to scare people, I think it is important to share exactly what fake medicines are and how they can harm people and why we must act. Fake medicines are deceitful products that either contain the wrong ingredients, the wrong dose, no active ingredients at all or even dangerous substances. Believe it or not, many police raids have discovered fakes that contained rat poisons and other harmful ingredients. The best case scenario for someone taking a fake medicine is no cure at all. However things can also turn more tragic. For malaria and tuberculosis alone, it is estimated that every year 700,000 people die because they take fake medicines[1]. This is outrageous.

The impact of fake medicines is also systemic. Fakes containing low levels of antimalarials or antibiotics stop short of fully fighting infections and can lead to drug resistant bugs. This places entire communities at greater risk. Also fakes can undermine confidence in the healthcare system. If patients wonder whether their pharmacies and their medicines are trustworthy, they may avoid seeking care in the first place. That is why we need to make people aware of the problem and help them take steps to avoid becoming victims of fake medicines.

As the developers of legitimate medicines, the research-based pharmaceutical industry has a role to play with others in stopping the crime, but stopping this global threat will, not surprisingly, take collective action.

I am proud to share that IFPMA, on behalf of our industry, has joined the Fight the Fakes campaign. Launched today by ten global health organizations representing healthcare professionals, research institutes, disease-specific organizations, product-development partnerships, global health and financing institutions as well as the industry, Fight the Fakes will create a global movement of organizations and individuals to speak up and spread the word about the under-reported but growing threat of fake medicines. I encourage you all to visit www.fightthefakes.org and follow the campaign on Twitter (@FightTheFakes).

It is up to all of us – working together – to make the voices of those who have suffered from fake medicines or who are engaged in the fight against fake medicines heard around the world.



[1] International Policy Network.

Data over dogma, what can the HIV/AIDS experience teach us for addressing the NCDs

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The recent United Nations Summit on MDGs fuelled the final push to achieve health-related Millennium Development Goals and focused attention on new Sustainable Development Goals (SDGs). It also caused me to revisit a 2011 report on improving access to drugs non-communicable diseases (NCDs) in developing countries and a report that I contributed to a

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John Hopkins University book back in 2012. In both I argued that reduction of the NCD burden requires a balanced use of prevention strategies and treatment of manifest disease, as it has been done in the successful fight against the HIV/AIDS epidemic and data-driven approaches.

Not that I want to discount the importance of prevention. Standing a patient’s bedside or in the cardiac catherization lab, I have experienced first-hand how limited our abilities are to reverse years of damage from poor health habits. Having trained at a public health school, I am very aware that better sanitation, nutrition and infection control have contributed more to longevity and prosperity of the human race than medicine.

But as a researcher I also know that reducing NCD risks is neither easy nor cheap. Changing the underlying, deeply engrained behaviours is hard, especially if they are linked to cultural traditions, such as diet. And contrary to widely held assumptions, prevention is not always more cost effective than treatment, because cost effectiveness depends on the “number needed to treat/prevent,” which reflects how many people have to receive a given intervention to avoid, for example, one premature NCD death. Preventive interventions tend to require a much higher number needed to treat/prevent, as they have to be applied to a large number of people, who would never have developed the disease. And preventive interventions take a longer time to show an effect as they typically cannot turn back the clock.

So we need to find the right balance between prevention and treatment for NCDs based on data and not just on dogma, as the successful response to the HIV/AIDS epidemic has taught us. We may have preferred to curtail promiscuity and intravenous drug use, but we settled for condoms and needle exchange programs. While hoping to eventually eradicate the disease, we realized that providing access to treatment will be important for decades to come.

Finding this balance between prevention and treatment for NCDs is both more complex and more important than it was in the case of HIV/AIDS. More complex because the conditions are caused by a complicated interplay of generic risk, health-related behaviours, environmental factors and ageing; more important because the burden of chronic illness is higher by orders of magnitude, yet the austerity environment makes major additional commitments from donor countries unlikely. We must make sure to get the best return from limited resources through sound and unbiased analysis.

But I fear that the global health community is pushing dogma before data at this point. The UN Political Declaration, for example, calls out prevention as “the cornerstone of the global response to noncommunicable diseases” (paragraph 34) and discusses several preventive efforts in detail, but devotes only one sentence to treatment (paragraph 44e). The WHO “Best Buys” interventions to reduce the burden of NCDs also emphasize preventive measures. Such skewing of priorities may result, if fully implemented, in inefficient resource allocation and limit options at the community level. As countries are now implementing their NCD action plans as agreed at the World Health Assembly 2013, there is an urgent need for evidence-based decisionmaking.

Fortunately, there are a variety of tools to help national and regional decision-makers and planners to facilitate such policy and resource allocation decisions. Most notably, an Inter-Agency Working Group (IAWG) on Costing, composed of UNICEF, World Bank, WHO, UNFPA, UNDP, and UNAIDS, has developed the One Health tool for supporting the costing, budgeting, financing and national strategies development of the health sector in developing countries with a focus on integrated planning and strengthening health systems. This model seeks to leverage the most useful components of the different tools that currently exist and is designed in a modular fashion allowing for program specific costing as well as health system component costing. The NCD chapter of the One Health tool is in process to be finalized soon.

In my mind, the first step towards reducing the NCD burden is to use such tools to formulate an action plan for each jurisdiction that defines the right balance of prevention and treatment interventions given local conditions and resources. Based on data not on dogma. The second step is to involve a broad range of stakeholders to launch collaborative effort.

The good news is that we are starting from a strong position. In contrast HIV/AIDS, where it took years to understand the biology of the disease and develop potent drugs, prevention and treatment of NCDs are well-researched. Many drugs are available, commonly as low-cost generics, and an active development pipeline exists. We don’t have to fear resistance formation so that drugs that are effective today will be effective tomorrow. But the one thing that we do not have is time and we must act before NCDs cripple developing countries.

Getting the Name Right

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At World Health Organization’s recent 57th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances Open Session to Stakeholders, Lisette Vromans (MSD) and I shared with the INN Expert Group and attendees IFPMA’s position on the increasingly important topic of non-proprietary naming of biotherapeutics. IFPMA represents manufacturers of both novel biologics and biosimilars and we support effective identification and pharmacovigilance of biotherapeutics to support patient safety globally. Simply put, what we shared with the INN Expert Group this week is that we need an environment that realistically allows for product level identification for all biotherapeutics – globally. After many years of working in the pharmaceutical industry, I believe this is the right direction and one that will bring a helpful level of consistency for all stakeholders as the number of biotherapeutics continues to grow.

Through our presentation to the INN Expert Group, we made clear our support of the implementation of a distinguishable name for all biotherapeutics, including the use of the INN identifier to be used with the INN, in order to support the INN naming policies as they currently stand and to strengthen the INN system globally. Such an identifier should be generated and managed by the WHO itself, as proposed by the INN Expert Group, to ensure global consistency. The identifier does not reflect the regulatory pathway of the biotherapeutic product. The system would function to distinguish all biotherapeutics, not just biosimilars. However, we will also need the support of national regulatory agencies in consistently applying the WHO INN biotherapeutics naming policy for this to be successful and we encourage the INN Expert Group to continue to engage broadly with stakeholders on the proposal, particularly recognizing that the INN is a voluntary system.

As more biotherapeutic medicines, originator and biosimilar alike, become available to patients, it is important that manufacturers remain accountable for the medicines they make. The gradually increasing divergence in how regulators handle naming of biotherapeutics weakens the INN system and may cause confusion among all stakeholders (regulators, prescribers, pharmacists, patients, scientific community). The healthcare community needs to be able to clearly identify which medicine was taken by

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a patient in order to ensure that we can accurately attribute potential adverse events. Accurate identification and effective traceability should be maintained from prescription, through dispensing and ADR reporting, and should not rely solely on any single identification measure (e.g. batch number recording). We believe the unique identifier concept could help deliver this global means of getting the name right for each biotherapeutic for each patient, every time.