Lect 14: Market Failures: Patents & Supplier Induced Demand

Barriers to Entry and Exit

  • Barriers to Entry:

    • Gatekeeping: Limits choosing any service, especially subsidized ones.

    • Laws and Regulations: Restrict who can be registered health professionals, requiring qualifications and development.

    • Legal Restrictions: Laws limit what healthcare can be legally traded.

  • Barriers to Exit:

    • Addiction: Some healthcare is addictive, making it difficult for patients to stop.

    • Necessity for Life: Continuing treatment is necessary for survival in some cases.

    • Technology Dependence: Ongoing maintenance restricts changing technologies.

    • Provider Obligations: Providers can't leave without arranging care for existing patients.

Research and Development Costs

  • Creating new products poses a significant barrier to entry.

  • Estimates of new drug costs range widely.

    • Simoens and Huys (2021) identify estimates from US944m944m to US2,826m2,826m per new medicine.

  • These costs account for the many medicines that fail before reaching the market.

    • Reasons for failure include not working, lacking evidence, or being too expensive to fund.

The Problem with Perfect Markets and New Drugs

  • In a perfect market, new drugs can be copied freely.

  • Other firms enter the market to compete, driving down prices.

  • The price reflects the cost of producing the drug and its value to patients.

  • The profit from producing the drug may not be enough to recoup research and development costs.

  • Companies may never invest if they can't recoup costs.

Patents as a 'Loophole'

  • Patents provide the sole right to produce a technology for a period.

  • This prevents competitors from using the same production method.

  • Patents don't necessarily protect against:

    • Different drugs for the same disease using different mechanisms.

    • 'Me-too' drugs that prevent the same types of medicine but in a slightly different way.

  • The appropriate patent duration is a crucial issue.

Pharmaceutical Issues in the US

  • The pharmaceutical issue has a substantial influence on policy in the US.

  • Pharmaceutical costs are much higher than elsewhere due to:

    • The impact of litigation

    • Lack of competition and issues with drug reimbursement.

  • I.MAK (2022) highlights patent abuse as the root of the drug pricing crisis.

    • The top 10 selling drugs in the US have a combined 740 patents.

    • On average, there are 140 patents filed for each of these drugs, with 66% filed post-FDA approval.

    • Four times as many patents are granted in the US as in Europe.

    • These patents prevent generics and biosimilars from entering the US market.

  • Co-founded by Priti Krishtel.

  • New Zealand will extend pharmaceutical patent terms as part of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership.

    • This extension will be for a maximum of 2 years (possibly shorter), to 22 years from the filing date.

Humira (adalimumab) by AbbVie

  • An anti-TNF agent that reduces inflammation and immune response in several conditions, including Crohn’s Disease.

  • Researched/developed by part of BASF, later purchased by Abbott Laboratories (now AbbVie).

Humira: Patents and Prices

  • In 1996, Humira cost 50,00050,000 a year per patient.

  • The patent was about to expire, but costs didn't fall.

    • AbbVie sued 10 competitors and then settled with them, delaying entry into the US market until 2023.

    • AbbVie made more patent claims (dosage, packaging, formulation differences) to extend protection to 2036 in the USA.

  • Price rises have continued.

    • In early 2023, Humira costs over US80,00080,000 a year per patient.

    • AbbVie has made 114bn114bn in revenue since 2016 from Humira.

Avastin and Lucentis by Genentech

  • Avastin (bevacizumab) and Lucentis (ranibizumab) are used to treat wet age-related macular degeneration (AMD).

  • Both are made by Genentech.

  • Both can be injected into the eye and are equivalent in preventing AMD.

  • Lucentis is newer and a fragment of Avastin.

  • Early comparison found slightly more adverse events with Avastin (40%40\%%) than with Lucentis (32%32\%%), but the side effects weren't related to Avastin in cancer studies with higher doses.

  • Lucentis (around 20002000 per dose) costs much more than Avastin (around 100100 per dose).

  • Genentech applied for FDA approval for Lucentis for AMD but not for Avastin, increasing profits with little benefit to patients.

Insulin

  • Discovered in the early 1920s by researchers at the University of Toronto.

  • The patents for insulin extraction were sold to the University for 11, on the basis that this “belongs to the world”.

  • Subsequent formulations have been patented at massive profit.

  • Eli Lilly charges US274.70274.70 for a vial costing US1010 to make.

  • In 2023, Eli Lilly limited out-of-pocket costs in the USA.

Patents: Necessity and Costs

  • Patents serve an important purpose; there is more market failure without patent protection.

  • However, a poorly functioning patent system carries a significant cost:

    • Changes to formulations, packaging, dosages, etc., are used to extend protection.

    • Off-label usage carries risks, but pharmaceutical companies seem to game the system.

  • One-fifth of drugs in development aren't developed by the marketing company but are researched and acquired.

  • Should the same patent protection be allowed when Pharma acquires technologies (especially from public sector research or via traditional medicines)?

Proposed Reforms for US Patents

  • To ‘fix’ patents in the USA, 5 reforms were suggested:

    • Raise the bar for patents – significant improvement for patients?

    • Change financial incentives for the patent office (currently paid per patent issued).

    • Increase public participation – communicate with the public about health and the value provided by patent applications.

    • Allow the public to have legal standing around patents – patients don’t have the right to sue for access where patents aren’t appropriate.

    • Expand oversight – create an independent unit to act as a public advocate.

Perfect Information

  • "Everybody knows the value of the good/service to buyers and sellers"

  • Do you have good information about:

    • The options available

    • The risks each option poses

    • The quality of treatments

    • What the treatment might lead to, etc.

Supplier-Induced Demand

  • "So doctor, what should I do?"

  • Demand is ‘derived’:

    • Based on expected contribution of healthcare to health.

  • Demand is ‘induced’ if:

    • Buyers rely on sellers to inform them about the good.

    • Buyers then act based on what sellers tell them.

    • Buyers demand more than they would have done if they’d had the information themselves.

Supplier-Induced Demand: Mechanism

  • The supplier increases quantity demanded:

    • Demand curve moves to the right.

    • Price charged and quantity used increases.

Primary Care and SID

  • Longden et al (2017). Australia.

    • Looked at urgent care primary care with the introduction of GP-substitute services.

    • Episodes labeled ‘urgent’ receive up to 100100 more than non-urgent ones.

    • Study found increases in urgent visits/decreases in other visits – more cases are labeled as urgent with 77m77m higher costs to government.

  • Other issues:

    • Target income hypothesis?

    • Relationships between area-level deprivation and density of GPs.

    • Barlow et al (2021) – highest GP concentrations in the most and least deprived areas.

Diagnostic Imaging and SID

  • Zabrodina et al (2020). Switzerland.

    • For inpatients, payments introduced based on diagnosis-related groups in 2012, replacing fee-for-service payments.

    • For ambulatory patients, fee-for-service remained.

    • Found that hospitals encouraged unnecessary repeat images (CT, MRI) for patients still under fee for service, with this costing CHF 6.5 million.

  • Akbari et al (2020). Iran.

    • Looked at ultrasonography and breast cancer screening.

    • Found 56% of 334 cases examined had undergone an unnecessary diagnostic scan, with this number higher in people with less education or who had health insurance.

Secondary Care and SID

  • Harder to identify specifically in secondary care, as smaller numbers and casemix is more varied.

  • Even if not SID, physician’s advice changes choices …

    • Patients can be seen by the same specialist publicly (longer waiting list) or more quickly, privately. (Specialists receive hospital salary plus private work.)

    • NHS hospitals (UK) can now charge private patients to use beds (up to 49% over costs).

    • Private patient units now exist within NHS hospitals, against a background of falling bed numbers.

    • Private patients ‘queue jump’.

Defensive Medicine

  • Defensive Medicine is the provision of additional goods/services (beyond what might be ideal or selected by the patient) by health professionals based on a fear of litigation.

    • Reduces the chances of missing something?

    • To convince patients that they’re being listened to?

    • Document that standard protocols are being followed?

    • Make sure that you’re being seen to 'do everything'?

  • There’s a particular concern here in the space of diagnostic tests.

  • Probably less important in NZ than elsewhere (and especially the US) because of ACC reducing the scope for suing clinicians.