Global epidemic?

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The statistic is startling: between 2018 and 2040, global cancer mortality will increase by 63% due to demographic changes alone.

The bulk of this impact is projected to be experienced by low and middle income countries as their, generally much larger,  populations age and economic development moves the cancer mix profile closer to those observed in high-income nations. Even now, although 59% of cancer cases occur in middle- and low-income countries, they see 71% of cancer-associated deaths.

As people live longer because they are not succumbing to previously fatal conditions, the proportion of populations for whom cancer is the cause of death will increase. It is this burden that the tag ‘epidemic’ is being used to label.

Australian age-standardised death rates, by broad cause of death, 1907–2016

In Australia, the changes in cause of death over time due to improvements in hygiene and healthcare, show that the age-standardised rates for cancer have not altered dramatically over the past century. In fact, cancer (all neoplasm) deaths, after adjusting for differences in age structure, peaked in 1985 (217 deaths per 100,000 population) and have subsequently declined to the 162 deaths per 100,000 population recorded in 2016.

Australia rated poorly on Cancer Preparedness for workforce density (in particular, radiation oncologists, clinical oncologists and surgeons); the capacity of radiotherapy equipment to meet patient need; and the change in out-of-pocket expenditure over 10 years.

To allow bench marking and initiate discussion on best practice, as part of the World Cancer Initiative, the Economist Intelligence Unit (EIU) Healthcare has published an Index of Cancer Preparedness (ICP) combining findings for 45 separate data points to provide a comprehensive overview of how well the 28 included countries are doing in the key areas of this challenge. The study was sponsored by Novartis, Pfizer and Roche.

The associated white paper describes the need for coordinated services across prevention, early diagnosis, treatment, palliative care and survivor support for effective cancer control. It describes elements that indicate the preparedness of a healthcare system to cope with the existing and projected burden including investment, national cancer control plans, accessible general health system and governance & population-based cancer registries.

The mortality-incidence (M:I) ratio (the number dying of cancer in a given period divided by the number of new cases) is used as a measure of healthcare system success against cancer. The EIU found that this ratio correlates closely, and negatively, with GDP. One of the biggest influences in poorer performance countries is that their healthcare systems are less successful in finding and treating curable cancers.

An interactive Excel workbook of the indicators and scores is available (here) by country and can produce comparative maps like that show below for tobacco control policies.

Sources: Image;  AIHW Deaths in Australia 18 Jul 2018, Figure 4.2; WHO International Agency for Research on Cancer 

Survival by cancer stage at diagnosis

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Cancer Australia continues to develop the National Cancer Control Indicators (NCCI) resource with a new data release presenting population-level national data on relative survival by stage at diagnosis for the 5-year period 2011-2016 for Australia’s highest incidence cancers. The data is available by age, gender, socioeconomic status (SES) and location.

The findings confirm that outcomes for Australian cancer patients mirror those reported for other jurisdictions. The positive impact of national screening programs on detecting cancers at earlier stages is clearly evident.

Stage at diagnosis

  • Over 75% of newly diagnosed cases of breast and prostate cancers and melanomas were stage 1 or 2 cancers.
  • The proportion of colorectal cancers diagnosed at more advanced stages was higher in people aged <50 years than those 50 years and over.
  • In 42% of newly diagnosed cases of lung cancer the disease had already metastasized (stage 4). Only 18% were diagnosed at early stages 1 or 2.
  • For breast cancer, people aged 50 years and over had a higher proportion of stage 1 cancers at diagnosis than those aged less than 50 years.
  • For lung cancer, melanoma, and prostate cancer, persons aged less than 50 years had a higher proportion of stage 1 cancers than persons aged 50 years and over.
  • The proportion of cancers diagnosed at early stages was lower in remote and very remote areas compared to major cities and regional areas.

Survival by stage at diagnosis

  • For metastatic cancers (stage 4), survival was higher among people living in major cities compared to regional areas at 1 year (20% compared to 16%), 3 years (6% compared to 4%) and 5 years from diagnosis (3% compared to 2%).
  • For metastatic cancers (stage 4), survival was higher among people living in the highest SES areas (SES5, 25%) compared to lower SES areas (SES1-3, 17%) at 1 year from diagnosis.

Males had lower survival by stage at diagnosis than females

  • For stage 1 cancers at 5 years from diagnosis, survival for males was 62% compared to 75% for females.
  • For stage 3 cancers at 1 year (survival for males 54% compared to females 64%), 3 years (21% compared to 32%) and 5 years from diagnosis (14% compared to 22%).
  • For stage 4 cancers at 1 year from diagnosis (18% compared to 22%).

Survival progressively decreased with increasing time from diagnosis

Stage 1 cancers survival was 91% at 1 year, 76% at 3 years and 68% at 5 years.
Stage 2 cancers survival  was 70% at 1 year, 42% at 3 years and 32% at 5 years.
Stage 3 cancers survival was 58% at 1 year, 25% at 3 years and 17% at 5 years.
Stage 4 cancers survival was 19% at 1 year, 5% at 3 years and 3% at 5 years.

Source: https://ncci.canceraustralia.gov.au/outcomes;

Cancer Australia’s Stage, Treatment and Recurrence (STaR) project. Cancer Australia, the state and territory population based cancer registries, the Australasian Association of Cancer Registries, and Australian Institute of Health and Welfare have collaborated to collect and combine data on incidence by stage at diagnosis data with mortality data from the National Death Index (NDI), for the top five high incidence cancers.

The State of Play

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At the time of federation in 1901, health was not a public policy topic. The new Australian Constitution granted the Commonwealth responsibility for quarantine, under s 51(ix) and for ‘invalid and old age pensions’ under s 51(xxiii). However, by 1945 the situation had changed, with health firmly on the political agenda. Consolidation of the welfare state principle in most democracies, galvanised by the suffering and sacrifice of WWII, created governments compelled to provide basic care for all their residents.

In 1946, the Constitution was amended granting the Commonwealth power to make laws with respect to health among others (1). Under s 51(xxiiiA), the Federal Government assumed power over social services, including ‘pharmaceutical, sickness and hospital benefits, medical and dental services (but not do as to authorize any form of civil conscription)’ (2). The various Acts that followed established the Australian health care system of today.

The states have power over hospitals and other services without the financial resources to fully fund those services, whilst the Commonwealth has funding capacity unmatched by the power to regulate the services it finances.’  Wheeler 1995

‘These divisions render coherent policy making, even at the state level, almost impossible.’ Duckett2004

The Commonwealth is financially the prevailing force, receiving over 80% of all tax revenues collected in Australia (State and local government taxes and levies accounted for the other).

Looking at New South Wales (NSW), in addition to the revenues it collects, the state receives grant revenue from the Commonwealth Government (including GST payments, National Agreements and National Partnerships) forecast to be around $32.5 billion in 2018-19, out of total state revenue of approximately $80 billion.

Health (28.6%, $22.9 billion) is the largest Recurrent Expenditure group for the NSW Government in 2018-19.  This is not the case with Capital Expenditure with transport representing 56.5%, and health a distant second at 12.5%. Those stadiums don’t rate costing only 2.2 billion!

The charts below relate specifically to the NSW Health Budget showing the proportion of spend by anticipated outcomes. Hospitals predominate in both. In yesterday’s state election, the  incumbent’s campaign claimed to have invested nearly $10 billion in health infrastructure since coming to office in 2011, with another $8 billion committed over the next four years.

Notes:

(1) Other sources of Commonwealth power include: s 96 (the power to make special purpose grants); ‘insurance’ (s 51(xiv)), the corporations power (s 51(xx)); the defence power (s 51(vi)); and, as amended by the referendum of 1967, s 51(xxvi) which empowers the Commonwealth to make laws for the benefit of Indigenous Australians’. Griffith 2006

(2) This conscription statement is the origin of the differences between Federal Government payment systems for PBS and MBS.

References available on request.

Who is subsidising who?

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Over 30% of all prescriptions written in Australia for PBS-listed medicines are self-funded as they cost less than the relevant Co-payment (under co-pay).

General patients (co-pay $40.30, 1 Jan 2019) are the sole recipients of this cost-shifting as the dispensing fee ($7.29) is greater than the Concessional co-pay amount ($6.50).

So why do the 8% of Services to General patients account for over 30% of Government PBS/RPBS expenditure?

The bar graph shows Benefit paid and differences in proportion of Services attributable to patient categories with and without inclusion of under co-payment numbers. Another way to present this, and as reported in the annual PBS expenditure & prescription tables, is as Average Government Benefit paid per Service.

The line graph shows the evolution of Average Benefit per Service by patient category over time. This graph is based on figures downloaded from Medicare Australia website (includes both Section 85 & Section 100). The total services (approximately 205 K) match the prescription numbers presented in the PBS Expenditure and Prescription Report for the same periods, which exclude under-co payment prescriptions (since reporting started in 2012-13).

Why is the Average Benefit per Service currently over five times higher for the General patient category compared to Concessional?

 

Is there a difference in the demographics of General and Concessional patients such that higher cost (F1) medicines are prescribed more frequently to General category patients?

Benefit paid per service ($) by ATC CV CNS Anti-Infectives GI Respiratory Oncology-Immuno Other
2017/2018 $ 15.24 $ 28.65 $ 149.68 $ 31.64 $ 46.16 $ 966.48 $ 62.98

In recent years, the peak and drop for average benefit paid per service for the General ordinary category mimics that of usage of new Hepatitis C treatments. Is there disproportionate prescribing of these and other higher cost drugs, such as oncologics and immunomodulators, between categories? To test this, benefit figures were downloaded from the Medicare Australia website for Hepatitis C medicines and reveal a split between General and Concessional patient categories of 39% to 61% in $1.37 billion paid by Government during 2017-18. Total service numbers (72,266) show a similar ratio with General 37% and Concessional 63%. For the ImmunOncology medicine, Nivolumab (Opdivo, BMS) total services (40,560) were split General 32% to Concessional 65% in 2017-18.

Perhaps the cause is an artefact of the huge volume, relative to General patients, of low cost (F2) items prescribed, and paid by Government for Concessional patients? Rosuvastatin and Atorvastatin had the highest prescription volumes in 2017-18, of these 37% and 30%, respectively were under co-payment prescriptions.

As a proportion of over co-payment prescriptions in 2017-18, Safety Net (SN) accounted for by 1.3% of the General patient category and 18.2% Concessional. The addition of approximately $40 and $6.50, respectively per script to Government expenditure is unlikely to be responsible for the large difference in average benefit per service paid, given the General SN category is so small.

Suggestions on what may be driving this difference are welcome. Hope you can provide me with a D’oh moment!

 

Sources: Simpsons; Medicare Australia Statistics; PBS expenditure prescriptions report tables

Three slices of the PBS

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Like it or not, product and service providers to the PBS are in competition. 

The winners and losers during development and roll-out of the 2015 PBS Access and Sustainability Package (PASP) left no doubt about that. 

A collaborative approach within the sector, to increase the size of the currently diminishing pie, will be more sustainable and deliver better health outcomes.

(1) Manufacturers

Manufacturer revenues accounted for approximately 70% of total Government Expenditure on the PBS/RPBS in 2017-18. In terms of costs, around 40% goes to innovator companies with single brand medicines in formulary F1; 20% to suppliers of multi-branded medicines in F2; and the remaining 10% for Combination products. The overall split, volume-wise, of prescriptions by formulary was F1, 11%; F2, 85% (half under co-payment and not represented in chart below); and Other, including combinations, 4%.

(2) Wholesalers

Wholesalers are remunerated via the regulated mark-up on ex-manufacturer price, currently 7.52%. This is agreed as part of the 5-year Community Pharmacy Agreement (CPA) negotiated with the Government of the day by the Pharmacy Guild. In 2017-18, payments to wholesalers represented only 4% of total Government expenditure on the schemes.

In their 2016 Submission to the King Review of pharmacy remuneration and regulation, the National Pharmaceutical Services Association (NPSA) re-iterated their view that the funding provided to wholesalers under the 6CPA is inadequate and unsustainable. This is even without including the impact of direct distribution to pharmacy model selected by some manufacturers.

The Community Service Obligation (almost $ 200 million per year) divided between full service wholesalers is not captured in the pie chart. However, a minimal increase on the previous CSO amount and a loss of  indexation during negotiation of the 6CPA, raises the question is anyone representing wholesalers at the table with Government?

(3) Pharmacy

The 2015 PASP/6CPA introduction of a flat, but CPI indexed Administration Handling and Infrastructure (AHI) fee successfully uncoupled community pharmacy remuneration from the price of medicines, and added to the growing range of professional services being remunerated. In addition to existing fees for dispensing, electronic prescriptions and incentives, such as to provide premium free medicines.

This approach has, and is, largely protecting pharmacy from the ongoing financial squeeze being experienced by manufacturers and wholesalers due to price disclosure, successive reforms and Department of Health activity.

Many of the professional service payments and pharmacy revenue, such as $600 m for the new Dose Administration Aid program and Minister Hunt announcements at APP2019, are not captured in the 26% of Government expenditure on the PBS/RPBS shown in the chart. For example, Clause 3.5 of the 6CPA notes: ‘The Commonwealth also estimates that community pharmacy will receive up to a further $4.8 billion from dispensing pharmaceutical items that are priced below the Maximum CoPayment.’ (1)

Bruce Annabel noted in a recent AJP article that ‘on average, pharmacies are receiving circa $30,000 pa services income’ with some generating over $200,000 pa.

With the PSA recently announced to join the 7CPA negotiations, and SHPA at APP2019 also wanting to play a role, as hospital pharmacists oversee more than 20% of annual PBS expenditure, there are going to be some unfamiliar faces at the table, very likely facing a new Minister of Health.

Sources: Department of Health Expenditure & Prescriptions Report; PharmaDispatch; Google Images

 

(1) The 6CPA bottom line of $18.9 billion to be paid to pharmacy over the life of the agreement, also excludes remuneration when community pharmacies dispense medicines under Section 100 special arrangements and the $372 m compounding fees which will be paid directly to chemotherapy compounders, who may not be approved suppliers.

The PBS pie

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Using a pie analogy for Australia Federal Government spend on the Pharmaceutical and Repatriation Benefits Schemes in 2017-18, the impact of rebates is clear with approximately $1 in 5 paid out as benefits for medicines, ultimately returning to Treasury.

The total $2.36 billion in rebates was repaid wholly by innovator manufacturers on the basis of Deeds of Agreement with the Commonwealth. Such arrangements are necessary to enable PBS listing with a published price that globally protects the return of investment for capital risked while a new product is still in patent.

The size of the proportion is an indication of the negotiating power of the Department of Health on behalf of Australian taxpayers following a positive PBAC recommendation. It could also be considered a measure of why Australia is perceived as a ‘free rider’ in terms of investment in development. It may be a reflection of a distorted Health Technology Assessment process, with policies such as lowest cost comparator that often bear no semblance to clinical practice.

Graph Source: PBS expenditure prescription report, 2017-18. Image source.

PBS structural change

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The long-term impact of 2007 PBS reforms are clearly evident when comparing patient categories by proportion of services and benefits. The introduction of separate formularies for single (F1) and multiple brand (F2) drugs plus successive price disclosure initiatives have fundamentally altered the structure of the Australian Pharmaceutical Benefits Scheme.

Despite ongoing increases in Concessional ordinary category (patient co-payment $6.50 in 2019) services (blue dashed line on graph), the cost paid/subsidised by Government (benefits, blue) has remained flat. Once a patient has paid $390 (60 items), the remaining services for the calendar year are provided free (Concessional Safety Net in green). Since the reforms the trend has been flat or downward, with recent significant drops most likely due to the $1 discount and other dampening policies on qualification.

While General category (co-payment $40.30 in 2019, shown in orange) services as a proportion of total has dropped away since the reforms, benefits paid by the Government for General patients (orange solid line) has almost doubled to account for 30% of total benefits in 2017-18. This is counter-intuitive as there are an increasing number of PBS items below co-payment and paid 100% out-of-pocket by patients. It is likely a consequence of the type and cost of medicines over the co-payment (refer earlier post PBS by therapeutic area showing increasing benefits paid for Oncology, Immunomodulators and Anti-infectives (Hep C) medicines).

The reducing service numbers in the General category (orange dashed) are influenced by the of loss of exclusivity on molecules with high prescription volumes and subsequent price disclosure. A similar dampening effect on the  Safety net qualification is also obvious over time.

Notes:

Patient category refers to a patient’s eligibility status at the time of supply of a PBS or RPBS pharmaceutical benefit. Concessions are available to Centrelink issued Pensioner Concession Card, Commonwealth Seniors Health Card and Health Care Card holders; as well as those with a Department of Veteran Affairs White, Gold, or Orange Card. General benefits apply if you do not have any of these cards. Further details are available on the PBS and DVA websites.

PBS Patient Category reports are available on the Government data.gov.au website as annual excel workbooks with month by month breakdown for the time period 1992 to 2016. Downloading directly from Medicare Statistics website is also possible for the period 1992 to current.

Image Source

PBS rewards innovation?

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Last financial year (2017-18) the average benefit paid by the Australian Government per subsidised PBS/RPBS service was approximately AU $60 (1). However, separation of payments by therapeutic area (see graph) reveals a startling two-tier PBS with the majority of areas experiencing little growth in benefit paid since 1992-93, contrasted by those with consistent or dramatic spikes in growth.

How might this be interpreted?

 

One possibility is that, based on published list prices, the PBS/RPBS is rewarding innovation. The steady climb in benefit paid per service for Oncology-Immunological agents reflecting the ongoing innovation in this sector, with the consistent introduction of new, more cost-effective therapies.

The average benefit paid in 1992-93 for these drugs was $202.24 per service (in real 2017 dollars) representing approximately 3% of total cost to Government. In 2017-18, this had risen to $966.48 per service and Oncology-Immunology accounted for 32% of total Government cost of the PBS, but only 2% of total services. Specialists and patients in other therapeutic areas could question how representative this is.

In 2016-17, anti-infectives accounted for over 25% of all benefits paid by Government coinciding with peak uptake of newly listed Hepatitis C treatments. Although given the magnitude of rebates required in this area, revealed by a now-withdrawn poster, this information should only be considered guidance to trends.

The impact of price disclosure on benefit paid is clearly illustrated by the Cardiovascular (CV) therapeutic area. Over the 26-year period graphed, services as a proportion of all PBS activity have increased from 22% to 31%. Meanwhile, in 1992-93 the average benefit paid by Government per service was $35.39, peaking at $40.99 in 2003-04, and dropping to $15.24 in 2017-18 where CV medicines account for only 8% of benefits paid.

In terms of proportions, CNS medicines have remained relatively stable over the time period: 18% in 1992-93 to 22% in 2017-18 of services; 10% and 11%, respectively for benefits.

Gastro-Intestinal medicines have experienced a similar trend with an increase in proportion of services from 11% to 15%, while the benefit dropped overtime from 16% to 9%. This is most likely a reflection of the continuing prescribing of PPIs, and their loss of patent exclusivity.

The Respiratory therapeutic area has experienced a decrease in both the proportion of services (10% to 6%) and benefit (12% to 5%). A look at raw numbers of services shows a slight increase from 11.4 to 12 million over the period.

Methodology:

PBS/RPBS data downloaded from the Medicare Australia Statistics website for the period 1992 through 2018 was analysed by therapeutic area. The Anatomical Therapeutic Chemical (ATC) classification system, as recommended by the World Health Organisation (WHO) for drug utilisation monitoring and research (WHO 2019 Guidelines), was used. Benefit and service data was collated separately and then used to calculate the average Government benefit paid ($) per service by therapeutic area. Adjusting the benefit to adjust for inflation into real 2017 dollars did not alter the trends.

References: (1) http://www.pbs.gov.au/info/statistics/expenditure-prescriptions/expenditure-prescriptions-twelve-months-to-30-june-2018

Image source: http://cancer.nautil.us/article/196/why-cancer-drug-prices-keep-rising-in-the- us

The size of the PBS in 2030?

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Extrapolating historical cost data, total Government expenditure on the PBS in 2030 is predicted to range from AU$11.5 to $14.5 billion.

The linear model based on actual PBS/RPBS expenditure after rebates in real terms (2017 $) from 1992-93 to 2017-18 (first graph) predicts a 2029-30 total cost of $14,400 m. This approach does incorporate the impact of Government policy changes and fiscal constraints, as well as the listing of new medicines and adjustment for inflation. Hence, the number is plausible assuming more of the same.

The 2% annual growth rate predicted by the trendline aligns with the recent IQVIA Institute Report on Use of Medicine (2019) that forecasts between 2019 and 2023, medicine spending growth rates in countries similar to Australia, are expected to be within a 1-4% range year on year. However, the Budget 2018-19 program expense for Pharmaceutical benefits, services and supply suggest that over $14 billion should be considered a stretch upside. This is due to the magnitude of projections for 2020-21 ($9,864 m) and 2021-22 ($9,787 m) once changes to supply chain arrangements take effect.

To better reflect the current environment, using only the past 10-years data, the 2030 PBS size lands at $9.7 billion (R2=0.1, low validity); while a trendline based on the last 15 years, predicts a total PBS of approximately $11.5 billion for 2030 (R2=0.7).

If benefit growth rates (%) are used rather than actual spend on the program as the basis for extrapolation, using linear extrapolation results in increasing negative rates (to -6.8%) and a PBS of AU$6.3 billion in 2029-30! As this is nonsensical, a moving average over 3 periods has been used to construct a trendline (second graph) and this provides an estimate of total PBS size of $11,865 m in 2030.

Using projected growth from 2014-15 to 2027-28 in real pharmaceutical spending per person from the most recent Intergenerational report (2015), plus the assumption that 80% of the growth is expected to come from non-demographic factors, the 2027-28 PBS total figure can be expected to be around $ 10.5 billion, supporting that the 1992-2018 linear extrapolation may be an overestimate.

Assuming the future holds the same in terms of policy & innovation, the total PBS will cost Government < $13 billion in 2030. How much of that amount goes to which parts of the sector will depend on how effectively stakeholders make their individual cases.

 

 

Sources: Expenditure data available from 1992 on the Medicare Australia Statistics website, picture & PBS logo

Evidence-Based Policy Making

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Those working in the pharmaceutical industry are very familiar with evidence-based medicine (EBM) and evidence-based decision making for reimbursement. As such, we have come to expect that therapeutic and funding choices will be made following a systematic assessment of the available data. In the public policy arena however, that there can, and should be, a direct link between ‘the evidence’ and policy decisions is somewhat more problematic. Research (limiting to scientific research in this context) and policy worlds are very different.

Priorities and outcomes

The purpose of research is to advance knowledge, while policymakers want practical solutions. The research available may not necessarily be what policy makers want. From a design perspective, while control arms and blinding are de rigueur for scientific research, it may not be ethical or even possible to test political subjects using these methods. Until recently, access to operational data held by Government agencies was often difficult for researchers. Scientists rewards are focused on quality and resulting publication, less so on how findings may contribute to the public good.

Timing

Policy is delivered continuously. Demand for research is unpredictable and sporadic, with Government officials and politicians looking for it at particular moments – during campaigns, after scandals, failures, changes of leadership. Researchers must anticipate, and be ready with completed studies. However, research timelines are often long, with funding and approval lead times that make them quite unresponsive to spikes in demand. So the needed research is often not available at the time when it is required. Unfortunately, the constant shifting sands of politics may also make a well-constructed study obsolete before it even gets started.

The recent call by the Minister of Health for a reformatting of, and improved access to, Consumer Medicines Information (CMI) is one of those cases where the research has been done. Prompted by similar discussions in 2016, and ongoing efforts by industry to move away from the burdensome requirement for pack-based copies and the associated version issues, relevant data and consensus building has been undertaken. This is the ideal scenario, where the relevant policymaker or stakeholder can immediately send the Minister’s office a brief outlining a preferred solution.

A matter of perspective

Although you will see the term ‘evidence-based policy making’ (EBPM), the Blair UK and Rudd Governments were proponents, generally, it is considered aspirational, rather than a good description of the policy process. Those on the research side, may allege that policymakers ignore, do not understand nor act on the correct evidence. Why don’t policymakers select the most effective, evidence-based solution? This is because they are interpreting ‘evidence-based’ from the same frame in which they view scientific data.

Conversely, those familiar with policy making know what a messy process it can be, and have no expectation that evidence-based policy making will be solely reliant on data. It is an overarching term that refers to the consideration of a broad range of research evidence (from general public and other stakeholders; and evidence from practice and policy implementation) as part of a decision-making process that also incorporates other relevant factors such as political realities, and public sentiment.

As in science, the availability of policy research can also be fraught, especially if those in the debate are not skilled in the use of evidence, or it is presented selectively. For example, the advocacy for access to medicinal cannabis on the basis of a small number of patients successfully treated, when the scientific evidence is insufficient on which to base a treatment benefit:risk decision. In this case, other factors including Federal party politics and potential economic gains for the states contributed to policy decisions.

A matter of approach

While science is based on rational thinking, policy literature refers to a concept known as ‘bounded rationality’, jargon that describes what really happens when policy makers have ‘unclear aims, limited information, and unclear choices’.  The term may come in handy next time you need to explain what turns out to have been a poor decision! Perhaps a new synonym for ‘uncertainty’? Policymakers use imperfect, and often ‘gut’ or emotion-based, short cuts to gather information and make decisions within a complex political environment.

Hence, it is unlikely that the robust scientific research which supports the development and introduction of a new medicine will be used in the same way when constructing public policy. While evidence plays a part in what is considered ‘good policy process’, it is in no way the whole show.

References available on request. Picture source