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May 12, 2023

Funding Pharmaceutical Research

The Roles of Private and Public Spending

The funding of pharmaceutical research often seems like a mysterious process. Obtaining information can be difficult, especially about private funding. Drug research money is spent by private companies, private foundations, and the federal government to create new drugs.

This article, the third in a series on the pharmaceutical industry, discusses how that funding is distributed, when it is spent, and how it impacts pharmaceutical research, before introducing some of the pros and cons of each approach.



What role do governments, industry, and private foundations play in funding pharmaceuticals?

The federal government, pharmaceutical industry, and private foundations all play a part in funding new pharmaceuticals. In fact, all pharmaceuticals on the market are created with a combination of both public and private funding. Because of this, it can be difficult to determine the role each specific entity has on the funding of pharmaceuticals, but there are some general tendencies of each funding source that can be compared and discussed.


What percentage of drugs have relied on public funding?

It is complicated to determine the percentage of drugs that have relied directly on public funding because all drugs receive public funding somewhere along the line of research and development. About nine percent of new drugs from 1990-2007 were patented by public institutions but then were licensed to private companies to continue their development. Another study showed that 48 percent of FDA-approved drugs from 1988-2007 were associated with a patent [link to article 2, patents] that was originally generated in the public sector, often with prior art (evidence that the drug was publicly known or publicly available). A further study found that National Institutes of Health (NIH) funding was either directly or indirectly involved with every drug that was approved by the FDA in 2010-2016.

 

How is funding distributed?

The majority of the funding for new pharmaceuticals is based in the private sector. Funding pharmaceuticals is a pricey endeavor and the number of new drugs entering the market has been increasing annually for the past decade. Private investment in the research and development of new pharmaceuticals in the U.S. was up to $83 billion in 2019. For reference, they spent $38 billion in 2000 and $5 billion in 1980. On average, pharmaceutical companies pay about a quarter of their revenues on research and development.


In 2007, U.S.-based foundations invested about
$75 million in biopharmaceutical companies. Funding hasn’t increased much at the government level since 2003, when it raised its allocation for the NIH to $26 billion. Comparatively, the largest philanthropic funder of pharmaceutical research and development is the Wellcome Trust at $909.1 million a year.


Only about twelve percent of the drugs that enter clinical trials are ultimately approved for distribution by the FDA. Every new drug that comes out can cost anywhere from under $1 billion in research and development to over $2 billion, though there are also sources that state that the cost is significantly less, at around $100 million.


Does the distribution of funding impact the types of drugs researched? 

Private funding generally looks at three factors when deciding whether to fund a new drug – the potential revenue over the lifetime of the new pharmaceutical, the costs to develop a new medication, and the procedures and policies that may influence the supply and demand for prescription drugs.

In general, there is a trend in drugs recently approved by the FDA to be specialty drugs that treat chronic, complex, or rare diseases, regardless of funding type. They tend to be biologics, which are usually expensive to develop, difficult to replicate, and often have high prices. Biologics are large molecule drugs that are based on living cell lines. This is partially a response to the profit-driven goals of the business and partially because the majority of drugs developed 30 years ago were for more widespread diseases and ailments.


One report found that pharmaceuticals associated with the treatment of infectious diseases were overfunded in the U.S. while treating lifestyle or environmental ailments was significantly underfunded. It was also found that government funding played more of a part in innovative and new drugs rather than “standard review” drugs.


Because pharmaceutical companies front so much of the money for research and development of these drugs, it can be concluded that they will choose to research the drugs that will make them money and prioritize them over the medications that may be better for the public good.


Funding varies depending on the priorities of the public or philanthropic source. For example, the NIH spent more on cancer research than all other types of research combined. However, the Wellcome Trust tends to spend around 14 times the amount on infectious diseases than it does on cancer research.


 What does the funding pay for?

There are several activities in the research and development of pharmaceuticals that require funding. First is invention, which is the research and discovery of new drugs. Next is development. Development encapsulates everything from clinical trials and application for FDA approval to the design of production processes for new drugs. There is also incremental innovation, when different dosages and delivery mechanisms for existing medications are determined, plus testing for new indications.

Product differentiation requires funding as well to test the new drug against any existing rival drug to ensure that the new drug is superior. Finally, there are additional clinical trials done after the product has reached the market for safety monitoring. These may be required by the FDA to detect side effects that may have not been observed in the shorter clinical trials required for the development of the drug.

At which stages are certain types of funding most important?


Basic discovery research is usually funded by either government or philanthropic organizations. Later stages of development including clinical trials are often privately funded. There is occasional collaborative support from government entities at this phase. In fact, $3.77 billion from private pharmaceutical companies is spent on grants for clinical trials each year. This is compared to the $750 million spent by the federal government through NIH funding. Needless to say, that while there is some funding for clinical trials through the government, the bulk of the money spent is through the private sector.


What are the pros and cons of public vs private funding of research?

Because there is usually a mixture of both public and private funding in the research and development of all new drugs, this question really is difficult to answer. The pharmaceutical industry is becoming increasingly involved at the basic research end of it, so much so that medical journals have requested that individuals not submit pharmaceutical research unless they are solely responsible for the work and had sole access to the data.Many academic institutions are now permitting pharmaceutical companies to attach strings to their research. Such strings might allow the companies to design the trials, write the papers, review the papers before publication, and even retain and analyze the data.


In the end, the different types of funding for pharmaceutical research are so tied together between public and private entities that it is difficult to determine which one is better or worse. Of course, pharmaceutical companies have different priorities than government and philanthropic funding, but since all of the drugs that become FDA-approved and enter the market have both private and public funding involved in their creation, there’s no real way to state which is better and which is worse. Both of them are involved and that’s just how things are done with regards to funding pharmaceutical research in the United States.

23 Dec, 2023
Context A CBC News article discussed the possibility of the Canadian economy heading into a recession, or whether the country has already passed that threshold. The article discussed this possibility based on slowed growth, high inflation, and the Bank of Canada’s continued interest rate hikes. Analysis A recession is a significant reduction in economic activity that occurs over a length of time, usually months or years. One of the most accepted definitions of a recession comes from the economist Julius Shiskin in 1974, who identified the threshold to an economic recession as two consecutive quarters of declining GDP, although economists often argue about the comprehensiveness of this measure. The causes of a recession can be quite complicated and have many contributing factors. Some common examples include a sudden economic shock such as the recent COVID-19 pandemic, excessive debt, asset bubbles, inflation, deflation, or large technological changes. One major factor influencing the probability of an economic recession includes rising interest rates from the Bank of Canada, which has implemented the highest hike in the shortest amount of time in all of the bank’s history, raising the rate over eight times since 2022. The Bank of Canada increased interest rates in order to curb inflation since rising interest rates discourage taking on debt and spending. This further encourages companies to lower prices or slow inflation to increase demand. Currently, the Bank of Canada is keeping at the 5.0 percent rate but has said that further hikes are not off the table as inflation may continue to exceed acceptable rates. Increases in interest rates can certainly contribute to or precede a recession. In fact, the Bank of Canada has raised interest rates three times to slow inflation since the 1960s and all three times this action led to an economic recession. Current fears of a looming economic depression are also not unique to Canada, as following the COVID-19 pandemic, the global inflation rate increased to 8.73 percent in 2021. This was due to supply chain issues, as well as the effect of the Russia-Ukraine War creating rising food and energy prices, as well as general fiscal instability. A majority of the World Economic Forum’s lead economists agreed earlier this year that we could see the beginning of a global recession starting in 2023, which would certainly affect the Canadian economy. The article also discusses the Canadian economy’s slowed economic growth, as the GDP has stagnated in the second quarter of this year. However, it suggests other factors may explain the decrease, including striking port workers in British Columbia, and the resulting negative effect on economic activity. An RBC report mentions how on a per-person GDP basis, there has already been a decline for four straight quarters despite a surge in population growth, and concludes overall predictions for GDP growth do not look promising despite local factors including Canadian wildfires and strikes. They also point to a 0.5 percent increase in the unemployment rate over the past few months, which has historically tended to indicate a looming recession.
21 Dec, 2023
Context The City of Ottawa Mayor, Mark Sutcliff released a statement about a revised plan for the redevelopment of Lansdowne, an urban public park containing historic landmarks and commercial venues. The project includes the demolition of a sports arena complex, stadium stands, and the building of a new event center, residential units, and retail space. Despite suggesting the new plan has addressed the concerns of residents, many issues remain. Analysis The City of Ottawa and the Ottawa Sports and Entertainment Group (OSEG) have been in partnership to develop Lansdowne since 2012 and finished an original redevelopment of the park back in 2014. A few years later in 2019, the financial sustainability of the park came to the city council’s attention, and in 2020 the partnership was extended another 10 years with direction to develop a new plan to revitalize Lansdowne. Consultation with community members started in 2020, with the original concept released last year in 2022, and a revised version released this month. Community feedback was acquired through various platforms including public information sessions, an open email for feedback, and public surveys. A summary report of that feedback was published on October 6th, which highlighted the six most common themes of community residents’ concerns. The first concern was related to the size and number of the multiple high-rise apartments which were designed to exceed 30 floors. In the new plan , they have removed one of the three planned buildings, with fewer total units in each, and only one tower with the potential to be built at 40 stories. Residents were also concerned about the loss of greenspace due to the new event center construction. Many people suggested they wanted that greenspace allocated elsewhere, or alternatively, an accessible greenspace roof on the event center. Although in the original plan the city had conceptualized a greenspace rooftop on the event center, this was scrapped in the new plan as it was deemed too expensive to maintain. Respondents wanted a restriction of vehicles to the premises to promote pedestrian safety, a concern that has existed since Lansdowne was first renovated back in 2014. They also wanted more public transportation infrastructure to and from the park, whether that is the local city buses, trains, or cycling infrastructure to reduce congestion on connecting roads. Relatedly, residents also desired more accessible public use space from washrooms to water fountains to usable and free space for people to occupy. The new plan has reduced the number of parking spaces for the residential buildings to meet the Bylaw limit of 0.4 spaces per unit, down from 739 to 336 spaces, while they added 36 new spaces for the event center. In terms of accessible public space, the new plan includes 27,000 square feet of space originally earmarked for the third residential building, now available for an unspecified “public realm.” Residents also wanted more local and less corporate or big-box businesses, to reflect the unique local community better. The new plan does suggest the amount of retail space has been reduced from 108,000 square feet to 49,000 square feet but does not directly address the desire to attract smaller, local businesses. Finally, there was also a concern about financial transparency of how the project is being funded and the resulting impact on the City. The Federation of Citizens Association (FCA) which represents over 70 community groups voted unanimously to oppose the new plan, which comes with a very costly price tag of $419 million, increased from $332 million of the first plan. They cite that the debt comes at a time when the transit system is facing major issues, and the city is struggling with a housing affordability crisis.
20 Dec, 2023
Context Newly elected Premier of Alberta Danielle Smith has defended her cabinet which is coming under fire over conflict-of-interest concerns. Environment and Protected Areas Minister Rebecca Schulz’s husband, Cole Schulz , may be lobbying the government in the areas that the Minister works in. Cole Schulz's firm is working on removing the protection of a threatened caribou range to make room for the oil and gas industry – which has raised concerns over who has Minister Schulz’s ear. Analysis The company that Cole Schulz is a partner with, Garrison Strategies, was hired by the Explorers and Producers Association of Canada and is working to influence the government on the issuing of reclamation certificates for oil and gas sites. The lobbyists are working to gain more access to protected caribou habitats to expand the oil and gas industry. They are hoping to “ address the moratorium on tenure in caribou regions ” which would effectively give them better access to land and investments. The Little Smoky and A La Peche herds in northwest Alberta were protected by a moratorium in 2013 which stopped the granting of new energy leases in this area. At the time, 95 percent of the herd’s range was heavily damaged. Phillip Meintzer of the Alberta Wilderness Association found that though records show that Garrison didn’t contact Environment and Protected Areas directly, the firm’s causes are “ too close for comfort ”. Meintzer also notes that as Garrison works on opening the protected caribou land for Alberta Energy, Environment and Protected Areas should be working on a protection plan for the federally and provincially designated threatened animal . Minister Schulz is working closely with the ethics commissioner, however, Danielle Smith confirmed that “ the ethics commissioner has looked at it, given guidance and there’s no violation [of the Conflicts of Interest Act]”. Cole Schulz also indicated that his firm wasn’t aware that Minister Schulz breached the Act at any time. Meintzer suggests that this situation “ calls for a further look ” from a third party. Sources https://globalnews.ca/news/9988998/alberta-premier-danielle-smith-rebecca-schulz/
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