How Ukrainians can get access to modern therapy, or why only 9% of medicines in Ukraine are innovative
Illya Gorodetskyy, Head of Market Access and Public Affairs at Takeda in Ukraine, Moldova and Belarus
Millions of patients and their families around the world are looking forward to new treatment methods or medicines. Their creation is vital because humankind has not learnt to heal many diseases yet.. Dozens of thousands of scientists around the world work hard to ensure that patients will get new medicines. The research and development of new medicines are based on years of experiments, testing, clinical trials, approvals and dealing with lots of challenges as well as on a constant need for considerable amount of investments. But the efforts are worth of it, because in the long run everyone benefits: new medicines not only provide longer and better lives for patients, but also improve a health care system and positively affect a development of the whole society.
The thousand-year history of medical developments has proven that transforming scientific knowledge into innovative medicines is a must. For example, if AIDS or hepatitis C were previously considered to be a death sentence for a patient, recent developments in treatment have turned them into manageable states and have increased lifespan of millions of people with those diagnoses. The developments of medicines for malaria, cancer and many other diseases have alsobeen successful. In particular, improvements in cancer treatment have reduced the death rate from cancer by 27% in the last 30 years. Although many diseases are not still completely curablethe search for solutions goes on.
Together with scientific institutions, pharmaceutical and biotechnology sectors play a leading role in the development of new medicines. The pharmaceutical and biotechnology sectors amount to more than 18.9% of the total R&D expenditures of each business worldwide. In 2018, pharmaceutical companies invested over 35 billion euros into research and development only in Europe.
At the same time the development of new innovative medicines or treatment methods is not only an expensive but also a time consuming and economically risky process.A pharmaceutical manufacturer spends on average 10–15 years for a development of one new medicine. Firstly, it covers the time for a creation of new ideas and a search for new compounds, later — clinical trials testing the efficacy and safety of each compound and a long process of medicine’s regulatory approval until patients receive an innovative therapy.
While investing in R&D, manufacturers understand that only one molecule out of thousands may eventually become an approved medicine. Or none of them at all. At the same time many samples are eliminated at later stages. This means that long-lasting efforts and investments may be spent on something that will not even become a drug in the end. However,manufacturers continue to contribute into new developments because even one chance for success is worth investing time, efforts and money so that patients will get medicine they need, which has not existed yet.
A success of a research is important not only for patients, doctors and pharmaceutical industrybut also for humanity as a whole. Patients' access to new treatment methods reduces disability and mortality rates and increases lifespan. It is believed that around 40% of a 2-year increase in lifespan measured from 1986–2000 can be attributed to the introduction and usage of new medicines.
It is worth to mention the economic benefits of innovations in medicine and pharmacy. For example, the development of a new treatment that slows down the onset of Alzheimer’s disease could have reduced medicare and medicaid spending on patients by $218 billion annually by 2050. These calculations are applicable for the US budget, but they illustrate how innovative developments may affect any country including Ukraine.
Another example: in 2006 the FDA (US Food and Drug Administration) approved a new HIV medicine that combines three existing active ingredients in one pill. The work on the medicine having taken four years to complete clinical trials allowed patients with AIDS to reduce their medication intake to one pill a day and reduce treatment costs for more than $ 6,000 compared to taking multiple pills.
In the overall a success of one innovative medicine may contribute to a development of a concomitant therapy and other new medicines. This so-called innovation cycle involves not only the development of new medicines but also promotes further researches and reinvestments in other medicines or technologies. Any cheaper analogs (generics) cannot be produced without an original medicine.
Obviously, all these efforts, years of work and multibillion dollar investments will not have a positive effect if in the long run patients do not have access to new treatment in their country. I'm not talking about a city or a town. This deals witha whole country. All in all, the decision on access to innovative medicines is made by a state, taking into account its financial willingness to help citizens. Developing countries including Ukraine should pay particular attention to it. In these countries patients usually do not have financial abilities to buy medicines they need unless such drugs are procured by the government. At the same time the use of innovative drugs leads not only to better treatment results but also to saving state funds.
In order to assess the economy of public funds from the use of innovative drugs, one should use the methods of pharmaco-economic assessment of medicines. This is an economic feasibility assessment of spending on a more modern medicine in terms of reducing the cost of treatment in general and better clinical effect. This method makes it possible to reasonably demonstrate not only clinical but also economic feasibility of using innovative medicines and treatment methods.
In Ukraine this approach of assessment is still being developed. I am convinced that it will simplify the access of Ukrainian patients to innovative medicines, which is the ultimate goal of any research and development. The introduction of pharmaco-economic assessment of medicines in Ukraine is particularly important since Ukrainians are treated mainly with out-of-date and less effective medicines, and a share of innovative drugs is much less in comparison with other countries. In monetary terms only 9% of medicines in Ukraine is innovative, while 91% is reproduced (generics). as a global biopharmaceutical company in Ukraine our task is to increase a percentage of modern medicines, as Takeda aims to increase access to innovative medicines for as many patients as possible.
That is why we emphasize that a dialogue between a state and a pharmaceutical industry is necessary. By "dialogue" I mean a regulated, transparent and understandable procedure of interaction between a manufacturer and a state which will allow each side to benefit from it. For a state it means optimizing health care costs and increasing a number of working people. For a manufacturer — transparent conditions for medicines availiability on the market. For patients — improved treatment results and longer lifespan.
Until these mechanisms are fully operational, Ukrainian patients need additional support which may be provided by pharmaceutical companies. For example, within the global Patient Assistance Program (PAP) our company provides access to its two innovative medicines for patients with Hodgkin's lymphoma and inflammatory bowel disease (IBD).
The opportunities provided by innovative medicines are enormous both for Ukraine and for the whole world. They not only change lives of patients and their families but also have a positive impact on the whole society by saving money, returning people to active life, giving new momentums to the industry. I am convinced that the dialogue between the state and pharmaceutical manufacturers will help to achieve an integrated approach to ensuring patients' access to modern effective treatment. It will improve both the duration and the quality of life for patients in our country.