The paper was updated on November 2, 2021.
Pharmaceutical industry is currently one of the most fast-developing ones. 2020 brought drastic changes to every industry, and the pharmaceutical one isn’t an exception – current issues in pharmacy 2021 are closely associated with the pandemic and its results. It has put the industry in the spotlight: whether mankind can rely on pharma when it comes to a serious threat. At the same time, the lingering COVID-19 crisis has not only resulted in numerous challenges, but facilitated some positive changes. Let’s take a closer look at the pharmaceutical problems and its recent trends.
Due to the ongoing digital transformation in the pharmaceutical industry, more data has to be collected and managed online, which makes the industry exposed to cyberattacks. Unfortunately, due to COVID-19 crisis, it’s impossible to focus on this problem to the full. Some of the risks that pharmaceutical companies have to deal with include: intellectual property theft, cyber espionage and state-sponsored attacks, insider threat, ransomware and phishing.
In addition, there have appeared more serious risks in relation to COVID-19 vaccine. Here are some of the possible threat scenarios.
- Cyber espionage to steal vaccine data
Any vaccine is a valuable piece of intellectual property, so the goal of such attacks is obtaining unauthorized access to information related to research proposals, drug development, manuscripts, virus testing, clinical trials, and drug manufacturing, which can be used by similar organizations developing their own medication.
- Attacking vaccine appointment system
A number of countries including the US have developed online appointment systems to prioritize vaccinations. Like any other online system, it is exposed to cyberattacks, for example, by individuals with hacking skills or cybercriminals who can subsequently sell access to vaccines and make profit of it.
- Using stolen vaccine data for disinformation
The targeted data in this case includes mainly research data, virus testing, and clinical trials that show side effects or potential vaccine-related problems. The stolen information on the vaccine can be changed by the hacktivists prior to publication with the aim of sowing disinformation: it may be profitable for some states that use misinformation to slow down vaccinations, or anti-vaxxer movement.
Therefore, pharmaceutical companies and related organizations should analyze their security systems and make efforts to mitigate possible risks.
One of the industry challenges that affects the global healthcare system in general and the pharmaceutical field in particular is associated with excessive and uncontrolled consumption of antibiotics that has resulted in antimicrobial resistance (AMR). Owing to free accessibility to antimicrobial drugs, their inappropriate prescribing together with poor medical awareness of patients, WHO mentioned antimicrobial resistance as one of the top ten threats to global health in 2019, shortly before the pandemic outbreak. As COVID-19 pandemic broke out, the situation only got worse. According to the paper published by Clinical Microbiology and Infection, about 70% of COVID-19 patients received antimicrobial therapy, while the overall proportion of bacterial coinfection was low.
The problem is that the need for developing new antibiotics is increasing, but AMR is developing faster than research and development is proceeding in this direction. In addition, WHO states that almost all new antibiotics that have appeared on the pharmaceutical market in recent decades are only variations of the drug classes discovered before the 1980s, which is why they cannot be as effective as it’s expected of them. Consequently, these new drugs aren’t able to tackle the challenge of spreading antimicrobial resistance.
Let’s consider the examples of some positive changes in this direction.
- Due to the lack of significant progress in antibiotics development, researchers had to explore alternative approaches to treating bacterial infections. The results of this research work were reflected in the WHO’s report “2020 Antibacterial Agents in Clinical and Preclinical Development”, which for the first time included a comprehensive overview of 27 non-traditional antimicrobial agents that can support the patient’s immune system and weaken the effect of the bacteria.
- In Uzbekistan, they joined the efforts of the Antimicrobial Resistance Center, Uzbekistan‘s National Reference Laboratory and the program Better Labs for Better Health established by the World Health Organization’s Regional Office for Europe that provides improved quality of laboratory testing services. The Center works on diagnosing, identifying and monitoring the emergence of drug-resistant bacteria, while the Laboratory supports these efforts by means of accurate identifying of the pathogen responsible for a patient’s infection.
- High-level global leaders joined the One Health Global Leaders Group on Antimicrobial Resistance launched by the heads of the Food and Agriculture Organization of the United Nations, the World Organization for Animal Health, and the World Health Organization. The group’s activities aim to focus global attention on the problem and force action to preserve antimicrobial drugs and avoid the consequences of antimicrobial resistance.
- On April 29, 2021, the WHO launched The Call to Action on Antimicrobial Resistance (AMR) during the closing session of the High-Level Interactive Dialogue on Antimicrobial Resistance to raise global ambition on AMR whilst accommodating diverse national circumstances.
To sum up, we can quote Dr. Tedros Adhanom Ghebreyesus, Director-General of WHO: “Numerous initiatives are underway to reduce resistance, but we also need countries and the pharmaceutical industry to step up and contribute with sustainable funding and innovative new medicines.”
Pharmaceuticals and the Environment
The negative impact of the pharmaceutical industry on the environment is one more serious challenge. Pollution caused by pharmaceutical plants affects organisms living nearby, because water and soil become contaminated with chemical substances, including antibiotics that can cause antimicrobial resistance. Also, pharmaceutical waste comes from pharmacies and healthcare facilities; certain amounts of drugs used in households are thrown away as municipal waste. In 2019, the European Commission (EC) issued a Communication that outlined a strategic approach to pharmaceuticals in the environment and covered actions that should be taken to reduce the environmental impact of the pharmaceutical industry. Consequently, the industry has already made some steps towards greener manufacturing since then.
However, with COVID-19 outbreak, there appeared some more factors contributing to environmental pollution by the industry: the amount of plastic personal protection equipment (PPE; includes gloves, face masks, face shields, suits, etc.) produced and used globally has increased significantly. For example, according to Science Daily, 3 million face masks are used in a minute worldwide, and most of them are disposable. At present, there is no official guideline on their safe disposal. Therefore, disposable face masks together with other disposable PPE is added to the regular amount of plastic waste and afterwards become an additional source of microplastic. The solution here could be massive production of biodegradable PPE.
Also, massive vaccination is likely to cause unfavorable environmental consequences. Potential problems are associated with:
- using freezers to keep vaccines
Some companies use hydrofluorocarbons (HFC) gases to freeze vaccines to minus 70 degrees Celsius for storage and transportation over long distances. The effect of HFC emissions on global warming is up to 23,000 times greater than that of CO2.
Additional CO2 emissions come from airplanes and trucks that transport the vaccine from the factories to people around the world. Also, bad logistics leads to wasting vaccines. So, efficient vaccine distribution is rather challenging.
Therefore, in addition to previous efforts on reducing the negative impact of pharmaceuticals on the environment, the pandemic forces the industry to take further actions to cope with the above-mentioned challenges.
Supply Chain Challenges
The ongoing COVID-19 crisis has also affected the pharmaceutical supply chain. Like in any other industry, pharmaceutical supply chain has to deal with labor shortages as a result of employees’ illnesses or deaths, travel restrictions, technological bottlenecks, shift in the demand for particular medications, and great uncertainty. Let’s dwell upon some of the most prominent challenges.
Raw Material Shortage
The shortage of raw materials, or active pharmaceutical ingredients (APIs), has been caused by the impact of the pandemic on two largest global producers of APIs and generics – China and India. In February, 2020, the US Food and Drug Administration issued a statement concerning the first case of a drug shortage following the COVID-19 outbreak in China. The situation with supply disruptions hasn’t got much better since then. In turn, Indian pharmaceutical industry is highly dependent on raw materials supplied by China: they import about 70 percent of Chinese APIs. In March, 2021, the Indian Ministry of Commerce and Industry restricted the export of more than 20 APIs due to the growing number of COVID-19 cases in India. In addition, the latest massive outbreak in India has resulted in raw materials’ price increase by up to 200 percent. These factors have become a matter of concern for the pharmaceutical industry worldwide as it can lead to shortages of essential drugs required to treat acute conditions or chronic diseases.
Vaccine Distribution Challenges
Current vaccination campaign is the largest and the most rapid in human history, which is why it’s accompanied by a number of challenges. First of all, they refer to the logistics of vaccine distribution which is influenced by the specific cold chain requirements for each particular vaccine (e.g. using dry ice or refrigerated storage unit during shipping, using Bluetooth to monitor temperature during transportation), security arrangements, and selection of the most efficient transportation to deliver vaccines to their final destination. At the destination point, additional challenges are associated with providing security (video-monitoring the vaccine storage area, using GPS sensors to monitor location while the vaccines are being transported, etc.) and the correct type of storage unit (refrigerator, freezer, ultra-low temperature freezer). Even less capable of meeting these challenges are low and middle-income countries, as many of them lack the necessary infrastructures to store, transport and deliver the vaccines effectively.
One more challenging thing in vaccine distribution is uncertainty about supply and demand issues. For example, there is no clarity about what the demand is going to be at any particular location. At the same time, the supply is still not enough in a great number of countries. In addition, the future demand for vaccines is hardly predictable, as no one is sure when herd immunity can be achieved, and if the existing vaccine can protect against new strains of the virus.
Moving Away From Animal Testing
Traditionally, biomedical research on animals has been a common practice in the pharmaceutical industry. However, recent statistics shows that 92% of drugs tested on animals are deemed ineffective for humans, and only 0.02% of animal-tested drugs are ever made available to the public. In addition, the fact that these animals experience pain, distress or die during the experiments is still a subject to debate. For this reason, the number of specialists and organizations around the world considering animal testing ineffective and unnecessary is increasing these days.
According to recent roundtable discussion on animal-free testing, they discussed some challenges related to using animals for drug testing. Firstly, it’s about using healthy animals to predict drug safety in diseased patients: despite that animals are regarded as ‘complete systems’, they cannot be regarded as surrogates for patients to the full. Secondly, the immune system of animals differs from that of humans. As a result of using animal models, about 90% of investigational new drug candidates that were progressed into clinical phases fail.
Despite the fact that the process of moving away from animal testing is expected to take many years, there are already some alternative testing methods, e.g. in vitro testing, computer models, participation of human volunteers, human-patient simulators. Therefore, the pharmaceutical industry is gradually moving towards the research standards in which animal testing won’t be necessary.
Digitalization of the industry that began not long before the COVID-19 crisis is still among pharma trends in 2021. Below are some of the technologies that contribute to higher production output, better quality of drugs and in this way increase pharmaceutical companies’ competitiveness.
Artificial Intelligence: Revolution in Drug Discovery
As for artificial intelligence, the COVID-19 pandemic has become to some extent the necessary evil that has accelerated the speed of technology adoption in the pharmaceutical industry: according to GlobalData report, AI will transform the pharmaceutical industry in the coming years. The urgent need for COVID-19 vaccine and medications have probably facilitated the implementation of AI in drug discovery, and has become a tipping point for the adoption of this technology across the industry.
In one of the recent publications in The Guardian, the contribution of AI into speeding up the process of drug development, has also been recognized. Pharmaceutical companies used to be criticized for slow adoption of technological advances. Without applying AI technology drug discovery is a slow, costly and not very successful process: the research and development together with regulatory approval of a new medicine takes about a decade and costs more than $2bn. At the same time, AI reduces the time required to analyze the vast amounts of scientific data to get a better understanding of disease mechanisms and find potential drug candidates, as long as it makes it possible to cross-reference piles of published data within seconds. The rapid progress with COVID-19 vaccine development is also associated with the use of AI. Also, AI is currently being used to find treatment for infectious diseases as well as for cancer, rheumatoid arthritis, autoimmune disorders. The technology is expected to at least double the success rate of drug discovery and save billions of dollars. The world’s top drugmakers, including US companies Pfizer, Johnson & Johnson, France’s Sanofi, and the UK’s AstraZeneca are now investing in AI.
However, not only drug discovery is going to benefit from AI implementation. As stated by Kitty Whitney, MSc, Director of Thematic Research, “The pharmaceutical industry is under increasing pressure, with rising costs of drug development, manufacturing, and marketing eroding profit margins. As well as drug discovery, AI can be applied across a wide range of other functions, allowing for improved clinical trial design and recruitment, smarter and more efficient supply chains, and targeted sales and marketing.”
Robots in Drug Manufacturing
According to recent Pharmaceutical Robots Market Size Report, there has been a growing need for automation in pharmaceutical manufacturing units as well as reducing costs for drug discovery. The introduction of robotics into pharmaceutical production has become the solution for the problem. This process has also been accelerated by the pandemic, as pharmaceutical companies had to overcome labor shortages and increase in-house manufacturing through automation rather than outsourcing.
The report also demonstrates numerous benefits of using robotics in product manufacturing: improved production output and product quality, occupying less space, absence of labor turnover, enhanced safety, reduced production downtime, and better waste management.
As for the manufacturing process itself, robots reduce error rates and relieve people from monotonous and time-consuming work, which taken together can improve a plant’s productivity. For example, in the US, owing to a partnership between Clemson University and Nephron Pharmaceuticals, a syringe-filling robot has been developed with the aim of tackling drug shortages. As usual, syringe-filling is done by technicians and requires up to five employees per day. The developed robot can fill, cap, and seal syringes without human participation.
As the practice of robotics utilization has proven to be efficient, this trend is likely to continue after the COVID-19 crisis: the long-term benefits of robots make them a cost-effective instrument in manufacturing processes.
Decentralized Clinical Trials
Clinical trials have made the way from site-based traditional trials to recent site-less decentralized trials (DCTs). The latter require minimum or even no in-person interactions between the patient and the investigator, including site personnel. As they are completely site-less and visit-less, the data is collected remotely by means of connected devices, telemedicine, or mobile healthcare providers. All the activities from A to Z are done remotely, at patients’ homes. Among other benefits, DCTs provide patients with a more streamlined experience, relieve them from time-consuming in-person visits, and provides opportunities for wider patient access, e.g. rural areas or distant communities. Still, it has certain risks, for example, undetected adverse effects or mishandling the data collected.
It’s easy to guess that COVID-19 pandemic has become a catalyst for wider adoption of decentralized clinical trials and immediately they’ve become a strategic priority for many pharmaceutical organizations. This trend is expected to last long after the COVID-19 crisis ends: DCTs offer an opportunity to fundamentally change the procedure of clinical research.
Pharmaceutical industry is one of the most affected by the ongoing COVID-19 crisis. It has multiple challenges to address this year: enhance cybersecurity across the industry, find solutions for overcoming antimicrobial resistance, cope with raw materials shortage and avoid the shortage of essential drugs, and others. At the same time, the pandemic has accelerated the adoption of numerous positive trends that are here to stay on a sustained basis, e.g. implementation of artificial intelligence, utilizing robots for pharmaceutical manufacturing, and carrying out decentralized clinical trials.