Pharmaceutical Industry & Distribution I

Pharmaceutical Industry (Original and Generic)

• The pharmaceutical industry is a significant driver of progress and innovation, globally.
• It invests substantially in research and development (R&D).
• In 2019, the EU spent approximately EUR 37 Billion in R&D.
• Clinical trial costs account for a significant portion of R&D (up to 50%).
• R&D costs are increasing at a rate of approximately 5% annually.
• The US and Canada hold the leading share of the global market, together comprising approximately 50% of the global market share.
• Europe accounts for approximately 25% of the global market.

Population Aging and Health Investment

• Population aging necessitates investment in health to extend the period of good health.
• Life expectancy continues to increase.
• Innovative medicines played a role in extending average lifespan between 2000 and 2009, contributing 1.74 years to the OECD average.
• Other factors impacting longevity include vaccination programs, improved risk management, treatment of risk factors, and increased access to healthcare.
• There is a clear need to continue investing in healthcare to prevent further increase in age related diseases.

Health Care Costs in the EU (2022)

• Health care costs in the EU show a wide variation across different countries.
• Costs are expressed as a percentage of GDP.
• EU countries demonstrated significant differences in the share of government-funded healthcare versus out-of-pocket spending.
• This illustrates disparities in healthcare systems and funding mechanisms across European nations.

Annual Real Growth in Per Capita Health Expenditure (OECD, 2006-2022)

• Health expenditures mirror GDP growth trends.
• There are unexpected variations in these trends.

Drug Costs in OECD Countries

• Developed countries spend more per capita on medicine compared to countries with lower economic performance in absolute terms (USD/capita).
• The share of drug costs in total healthcare costs is relatively lower in countries with lower economic performance.
• Pharmaceutical expenditure in 2020 represented a certain percentage of total healthcare spending for OECD countries.

Annual Average Growth in Retail and Hospital Pharmaceutical Expenditure (2011-2021)

• Retail and hospital pharmaceutical expenditures displayed varying average growth rates across different countries.
• The data are presented, in some circumstances, in real-terms over time.
• These growth rates reflect trends in demand and spending patterns within the pharmaceutical industry.

Availability of Innovative Therapies to Patients (2016-2019)

• The number of available medicines varied between European Countries, depending on the year of marketing authorization.
• Numbers differ in terms of granting of access to reimbursement list in some countries.

Key Economic Indicators (Czech Republic)

• GDP per capita growth in the Czech Republic demonstrated 0.7% in 2023
• The average annual growth is forecast to be 2% between 2024 and 2029.
• The Czech Republic's GDP per capita is below the EU average but surpasses Poland and Slovakia in size.

Key Healthcare and Pharmaceuticals Metrics (Czech Republic)

• Healthcare spending in Czechia decreased slightly and matched the EU average for the first time in 2020.
• Pharmaceutical expenditure levels for Rx and OTC in 2021 are presented in USD.

Expenditures on Medicines in the Czech Republic (2015-2019)

• CZK 95 billion is the total drug costs in the Czech Republic.
• CZK 65 billion represents the Health Insurance Company's drug costs.
• 30 billion USD accounts for Medicines in hospitals and clinics.
• 30 billion CZK is a figure for expenses in private healthcare.
• 12 billion CZK represents over-the-counter drugs.

Availability of Innovative Therapies to Patients (Time/Rate- 2016-2019)

• The time to availability (length of delay) is the number of days between marketing authorization and availability to patients in European countries.
• The rate of availability is the percentage of medicines available to patients in European countries.
• The provided data is for certain countries and does not exclude all information.

Accelerating Patient Access to Innovative Therapies

• Europe is a lagging region in approving new medicines, compared to the US and other developed nations.
• Shortening the approval process to 7 days, instead of 67 (limited exceptions), can expedite the development of innovative medicines and treatments.

Time to Availability (2016-2019)

• This is the amount of time between marketing authorisation and patients' access to new products.

Rate of Availability (2016-2019)

• Includes the percentage of medicines available to the patients, depending on the approval in Europe.

Number of Employees in the Pharma Industry (Innovative) (2019)

• The pharmaceutical industry directly creates jobs, but those jobs can also indirectly create many more.
• Data on employee numbers within the innovative pharmaceutical sector was collected.

R&D in the Pharmaceutical Industry

• The average time frame for new drug development is 12-13 years.
• Estimated development cost for a new drug (2016) is $2.5 billion.
• Successful launch of an innovative biological drug will occur after 10000 molecules have been screened.
• Time to market of innovative pharmaceutical drugs averages 10 years.
• The process of developing new biological medications involves a great number of steps.

Costs of Drug Development

• The cost of developing a new medicine exceeds 30 billion CZK.
• Pre-clinical trials stage costs more than clinical studies if the drug succeeds.
• Each stage of drug development involves significant expense and numerous patients, and involves a lengthy process.

Pharmaceutical Industry Research and Development in Europe

• The overall pattern of pharmaceutical industry spending on R&D is constantly increasing.

Access Inequality in Europe (2023)

• Access to medications varies across European countries.
• Some countries show higher rates of availability than the EU average, others lower.

Overhaul of Pharmaceutical Legislation (Europe)

• The need for better-integrated market access and competitive frameworks was cited as one of the key changes needed to be made to the legislative framework over 20 years.
• Shortages and security of supply were identified as critical factors.

European Pharma Legislation: Patent Protection (2023)

• The legal protection period for a medicinal product is up to 20 years.
• Specific conditions and processes for new medicinal products are defined in detail to protect patients' access to innovation.

Roles and Functions in the Innovative Pharma Industry (non-production)

• The innovative pharmaceutical industry encompasses functions such as sales, brand management, market access, medical affairs, commercial functions (marketing, and sales, etc.), clinical research, patient safety, drug regulatory, and legal and compliance functions.
• Each department plays crucial roles in the overall success of new drug development.

Sources

• Various organizations and websites provide data about the pharmaceutical industry and healthcare, including the Czech Statistical Office, EFPIA, and the OECD.

This quiz explores key concepts surrounding generic medications, including their purpose, regulatory requirements, and market dynamics. It also covers the differences between original medicinal products and generics, the clinical trial process, and the implications for healthcare systems. Test your knowledge on the essentials of generic medicines and their role in modern healthcare.