Many studies were started in a short time in 2020 in order to find medicines and vaccines against COVID-19. The first vaccines were already approved at the end of 2020. A really great performance because the development process, for example, for a vaccine, normally takes about twelve years and is full of risks.
During the corona crisis, various phases of development and registration were conducted in parallel, where possible, with cooperation from the authorities. The process went much faster this way, without making any concessions regarding the vaccine’s safety.
There were 18,000 medicines in different stages of development in 2019. In order to develop an effective, safe and effective medicine after discovering a new molecule or operating mechanism in the laboratory (preclinical phase), the pharmaceutical companies conduct clinical research in various phases. The proper dosages, efficacy and safety are examined during these phases. This research is only possible due to the participation of (often) thousands of volunteers and patients. And if all of the test results are positive, after years of research, the step is taken to apply for registration for the medicine. After a positive recommendation from the European Medicines Agency (EMA), which has been based in Amsterdam since 2019, the European Commission then permits the medicine to enter the market. It is then, in principle, available for patients. But the compensation from health insurance and the inclusion in physician treatment guidelines also often requires several months.
Vaccines have drastically decreased the number of deaths due to infectious diseases such as whooping cough, tetanus and polio. In 1950, a total of 184 Dutch people died from these three diseases. That number dropped to one in 2018. As a result, these diseases have been almost completely eradicated in the Netherlands. In order to keep it that way, it is important to vaccinate as many people as possible. Since the start of the National Immunisation Programme in 1957, millions of Dutch people have already been vaccinated. A vaccination rate of at least 95% is required in order to be able to keep virus outbreaks under control. Scientists assume that with COVID-19, a vaccination rate of at least 70% is sufficient in order to control the coronavirus.
The development of a vaccine begins with a search for the right “key”. Then there must be a search for a safe way in which to package it and bring it into the body. Then the proper immune response must be generated so that the virus can no longer cause harm. Finally, it is important to produce the vaccine on an industrial scale.
Vaccine development is a complicated process. Under normal circumstances, the entire research process lasts 10 to 15 years. More than 90% of the candidate vaccines can drop out because they are not safe enough or do not work well enough.
COVID-19 poses an enormous challenge to pharmaceutical companies. Due to the enormous social and economic impact, we cannot wait years for a vaccine. In order not to lose any time, the phases of the development process are conducted in parallel where possible. The EMA has an important role in this process. The European agency assesses the corona vaccine research data as soon as it becomes available. Normally, this assessment occurs only when the data is entirely complete.
A large number of studies into an agent against COVID-19 were started in a very short time. On 27 February 2020, when the first infection was identified in the Netherlands, 67 studies into the virus had already been started. The number of studies increased the most in the first quarter; the number of studies grew from one to almost four hundred in approximately three months. That is an average of four or five new studies per day.
The majority of the studies focus on the development of medicines for patients who have already been infected. These mainly regard medicines that reduce the symptoms of the disease and antiviral drugs that weaken the virus. The other studies focus on the development of a vaccine that can be used to prevent infection.
The research into a medicine against COVID-19 can be divided into three categories.
The treatment category includes research into a medicine that can influence the body’s response to infection. These are, for example, medicines that inhibit inflammation or strengthen the immune system.
Antiviral drugs are medicines that focus on eliminating or neutralising the virus, for example, by disrupting the virus’ multiplication.
Vaccines, on the other hand, are preventative and protect people against COVID-19. The vaccination triggers an immune response, which ensures that the body is resistant against a later infection.
A vaccine contains pieces of bacteria or viruses or their weakened forms. When these enter the body, they are recognised by our immune system. That system produces substances in order to render the vaccines harmless. If, after some time, the body is confronted with these viruses or bacteria, the immune system takes action.
A vaccine can ensure immunity in different ways. A protein subunit vaccine contains a piece of the antibody, but no parts from the virus. Reproduction is therefore impossible. A viral vector vaccine uses an innocent virus to provide a set of instructions to immune cells about how an antibody can be made.
A DNA/RNA vaccine contains messenger RNA (or DNA), with which a specific protein can be produced by the body. This does not change the DNA and cannot cause damage to the body.
Drug development is becoming increasingly more advanced. More often, it no longer concerns a pill, but rather a gene or cell therapy (ATMPs – Advanced Therapy Medicinal Products). In gene or cell therapy, genetic modification adds a (for example, missing) property to cells that initiates specific processes in the body. In this way, for example, it is possible to switch off cancer cells or produce a missing enzyme or coagulation factor.
Gene and cell therapies are often complex therapies. What is special about these treatments is that they usually work for a long time and in some cases, may even be curative. Of the 1,078 gene and cell therapies in development, more than half are focused on cancer.
Pharmaceutical companies and universities worldwide are working hard on new medicines. They do that in laboratories (in the preclinical phase) and with patient studies (in the clinical phases). There were approximately 18,000 medicines in development in 2019. Pharmaceutical companies formed the basis of 83 percent of all new medicines. Drug development is complex. Only a very small percentage, less than 10% of the substances studied, reach the finishing line.
Approximately one-third of all medicines in development are focused on cancer. There are also many antibodies and gene therapies in development.
The Horizonscan from the National Health Care Institute (Zorginstituut Nederland) provides an overview each year of innovative medicines that are expected to be available on the market within a few years. The Horizonscan focuses on medicines inside and outside of the hospital. Many medicines are expected in the coming period for skin disorders, bacterial infections and diabetes. Many new medicines for cancer are also anticipated.
Patents are the basis of the innovative pharmaceutical industry. They stimulate innovation in two ways. First, they offer protection for a number of years against other parties manufacturing the identical medicine, giving a pharmaceutical company a greater chance to recoup the investments. And second, the company can inspire other researchers to develop innovations by making its knowledge public.
Applications for patents must be submitted just after an invention is made. You can obtain a patent on something that is new, inventive and industrially applicable. For example, on a new substance that has a positive effect on a disease. The patent is valid for 20 years starting from the patent application. Of those years, usually 12 years have already passed when the medicine is fully developed and registered. When the patent expires, other companies can reproduce the medicine exactly. This ability generates price competition and the price often falls significantly. During the patent period, companies can, of course, also develop a different medicine for the same disorder. These medicines then compete with other patented medicines. This means that, in reality, the effective patent period often lasts only a few years.
It costs an average of € 2.2 billion to develop, test and bring a new medicine to the patient. More than half of these costs are costs of capital. Those costs consist of the return that investors, such as pension funds or healthcare insurers, require on their capital. They require a higher return according to how long they make their capital available. That can increase in the approximate 11 years required for drug development. The costs of failed research also comprise a large portion of the development costs. That is because the vast majority of medicines do not reach the finishing line. Approximately 89% drops out after the preclinical phase.
Costs of capital can be restricted by already making the new medicine available to patients earlier, provided it is safe and effective. That has another important benefit. It means that more people receive a medicine at an earlier stage, which can have a great effect on the quality of their lives.
Clinical research is an essential phase in the development process of a new medicine. In 2019, the number of clinical trials with medicines in the Netherlands increased to 607. Clinical research contributes to the availability of new innovative treatments for patients and increases the level of healthcare providers’ knowledge. In addition, clinical research contributes to the economy, in the form of employment and investments in research and development.
In addition to research with medicines, clinical research also consists of observational and other intervention research.
The number of patients participating in clinical trials has been decreasing since 2014. The decrease is especially visible in the observational research category. Compared to 2014, only half of the number of patients participated in clinical trials in 2019. The number of patients participating in clinical trials with medicines has been more or less stable at 40,000 people since 2011.
The Dutch Clinical Research Foundation (DCRF), a platform in which all parties are represented in clinical research, is working on a strategic agenda to stimulate clinical research in the Netherlands. In this way, the Netherlands can become a leader in clinical research in Europe.
The Netherlands has accrued a great deal of knowledge and expertise over a relatively small geographical area in the field of drug development. Consider the universities, the biopharmaceutical companies and the number of clinical studies. The excellent infrastructure, with examples such as Schiphol and the Port of Rotterdam, but also certainly the arrival of the European Medicines Agency (EMA) in Amsterdam in 2019, makes it even more attractive for pharmaceutical companies to establish themselves in our country.
PharmInvestHolland, a public-private partnership that also includes the Association Innovative Medicines, has been committed since 2017 to setting up an optimal business environment.
Medicines provide a valuable contribution to society and are indispensable for the daily functioning and health of people. It is important that people have confidence in medicines and that they use them responsibly.
This occurs, on the one hand, through customised treatment as much as possible, through improved screening, diagnostics and understanding of health data such as patient and treatment data. As a result, two birds are killed with one stone: improved effectiveness and waste prevention.
On the other hand, it is important to be aware of the impact of medicines on the environment and to deal with it responsibly, from development, manufacture and use to processing of waste. Examples include the use of raw materials, energy consumption and waste flows during production, CO2 emission, packaging waste and the effects of medicinal residues on the water. The Coalitie Duurzame Farmacie [Sustainable Pharmacy Coalition], in which Bogin, KNMP (Koninklijke Nederlandse Maatschappij ter bevordering der Pharmacie) [Royal Dutch Pharmacists Association], Neprofarm and the Association Innovative Medicines (AIM) work together, is committed to this purpose.
Continually more parties in healthcare have become motivated by the Green Deal Sustainable Care (Green Deal Duurzame Zorg) to commit themselves to making the healthcare sector sustainable. This is necessary because the healthcare sector contributes to environmental impact and climate change. And healthcare itself is confronted with the effects of climate change on health. Counteracting climate and environmental impacts is therefore also in the interest of the healthcare sector.
The purpose of the Green Deal is to accelerate the sustainability of the healthcare sector together. In the meantime, 239 parties have signed the Green Deal Sustainable Care, including healthcare providers, hospitals, industry organisations, governments and pharmaceutical companies.
The return on research and development (R&D) of new medicines has decreased since 2010. The return is the ratio between investments of the companies in R&D and the expected revenue from the medicines developed. This return provides the best insight into the long-term profitability of pharmaceutical companies.
According to a recent Deloitte study, the average return of pharmaceutical companies on R&D decreased to 1.8 percent in 2019. Deloitte’s sample shows that this is due to the fact that the development costs are increasing, but the revenue is decreasing. The decreasing return makes it more difficult to continue financing drug development in the long-term.
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