Laws around oncology
64 statutes, regulations, guidance documents, schemes and 4 court rulings across 9 jurisdictions, from the 1938 Food, Drug, and Cosmetic Act to the 2025 European Health Data Space. Each entry states the instrument, the year and the primary text, then what it changed for patients and companies and what is argued about it.
By theme
Five questions a law can answer. A law can sit under more than one; each heading links to the bottleneck the laws in it bear on.
Getting drugs approved faster (24)
Bottleneck: Regulatory divergence between regionsThe pathways, designations and reforms that decide how much evidence is enough, and how soon.
- Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments
The 1938 US law that makes a company prove a medicine is safe before selling it, and the 1962 amendments that added the requirement to prove it works, which is why every cancer drug approval rests on controlled trials.
- Orphan Drug Act 1983
The 1983 US law that pays companies to develop drugs for rare diseases with seven years of market exclusivity, tax credits and fee waivers, which is why so many cancer drugs are first approved for a rare subtype.
- Orphan drug designation
A status for drugs treating rare diseases (under 200,000 US patients, or under 5 in 10,000 in the EU) that gives the company tax credits, fee waivers and seven to ten years of market exclusivity, to make rare-disease drug development worthwhile.
- Expanded access (compassionate use)
The regulated way a seriously ill patient who cannot join a trial can get an unapproved drug: the doctor asks the company, the company agrees, and the regulator reviews the request, usually within days for a single patient.
- Accelerated approval
FDA approval based on early evidence (like tumour shrinkage) on condition that a confirmatory trial follows.
- Fast Track and RMAT designations
Two of the FDA's expedited programmes: Fast Track gives drugs for serious unmet needs more frequent FDA meetings and rolling review; RMAT is the equivalent for cell and gene therapies. Neither guarantees approval or changes the evidence standard.
- Regulation (EC) No 141/2000: EU orphan medicines
The EU's 2000 answer to the US Orphan Drug Act: ten years during which no similar medicine may be authorised for the same rare disease, plus fee reductions and scientific advice, for conditions affecting no more than 5 in 10,000 people.
- Regulation (EC) No 726/2004: the EU centralised procedure
The 2004 EU regulation under which every new cancer medicine is assessed once by the European Medicines Agency and authorised for all member states by the European Commission, and which also carries the rules for conditional authorisation and compassionate use.
- Conditional marketing authorisation (EU)
The European (and Chinese) counterpart of accelerated approval: a drug for an unmet need is authorised on less complete data with specific obligations to deliver confirmatory results, renewed yearly until converted to standard approval.
- Abigail Alliance v. von Eschenbach (2007)
A 2007 US appeals court ruling that terminally ill patients have no constitutional right to buy unapproved drugs after phase 1, which pushed the access movement toward legislation and eventually the Right to Try Act.
- Breakthrough Therapy / Priority Review / Priority Voucher
Breakthrough Therapy, Priority Review and the Priority Voucher are FDA fast lanes for drugs that look substantially better than existing options.
- FDASIA 2012 and the origins of the expedited programmes
The 2012 US law that created Breakthrough Therapy designation and made the paediatric study laws permanent, sitting on top of the 1992 user-fee law that gave the FDA review deadlines and the 1997 law that created Fast Track.
- Sakigake designation (Japan)
Japan's fast lane for innovative medicines developed there first: a designated drug gets priority consultation, a six-month review instead of twelve, and a price premium, in return for early development in Japan.
- 21st Century Cures Act
A 2016 US law that funded the Cancer Moonshot, created the RMAT designation for cell and gene therapies, told the FDA to work out how real-world data could support approvals, and made companies publish how patients can request unapproved drugs.
- Japan conditional early approval and time-limited approval
Japan can approve a medicine for a serious disease on early data when a confirmatory trial would be hard to run, on condition that evidence is gathered after launch; for cell and tissue products a 2014 law allows a time-limited approval that must be confirmed within seven years.
- Right to Try Act 2018 and state right-to-try laws
A 2018 US law letting patients with life-threatening illnesses ask a company directly for a drug that has passed phase 1 without going through the FDA; companies still decide, and in practice most access happens through the older expanded access route.
- China Drug Administration Law (2019) and expedited pathways
China rewrote its drug law in 2019 and its registration rules in 2020, writing in priority review, conditional approval, breakthrough designation and acceptance of foreign trial data, which turned the world's slowest big regulator into one that approves cancer drugs within months of the FDA.
- India New Drugs and Clinical Trials Rules 2019
India's 2019 rules for approving new drugs and running trials set deadlines for the regulator, fixed compensation for trial injuries, and allowed waivers of local trials for drugs already approved abroad, a waiver widened in 2024 for cancer and orphan drugs.
- Project Orbis
Project Orbis is a scheme where the FDA and partner regulators (Australia, Canada, UK, Switzerland, Singapore, Brazil, Israel) review a cancer drug at the same time.
- France: early access (accès précoce), formerly ATU
France pays for promising medicines before they are approved or reimbursed: the ATU system did this from 1994, and since July 2021 the Haute Autorité de Santé grants early access for presumed innovative drugs in serious diseases, with the company setting the price and repaying the difference later.
- ILAP (Innovative Licensing and Access Pathway)
The UK's post-Brexit scheme, launched in 2021 and refreshed in 2025, that brings the medicines regulator, NICE and the NHS together early in a drug's development so that licensing and the decision to pay for it can happen close together.
- Medicines and Medical Devices Act 2021
The 2021 UK law, passed after Brexit, that gives ministers power to rewrite the rules for licensing medicines, running trials and regulating devices without new primary legislation, and that created a patient safety commissioner.
- FDORA 2022 accelerated approval reforms
A December 2022 US law that lets the FDA insist the confirmatory trial for an accelerated approval is already running before the drug is approved, and gives it a quicker way to withdraw a drug when confirmation fails.
- EU pharmaceutical package reform (2023 proposal)
The biggest rewrite of EU medicines law in twenty years, proposed in 2023: shorter default protection from generic competition with extensions for launching everywhere in the EU and for meeting unmet needs, faster assessments, and tighter orphan and paediatric rules, argued over by Parliament and Council since.
Paying for them (27)
Bottleneck: Prices and valuePatents, exclusivity, generics and biosimilars, price negotiation, reimbursement and the funds that bridge uncertainty.
- WHO Essential Medicines List for cancer
The World Health Organization's list of medicines every health system should provide, which now includes about 60 cancer drugs from cyclophosphamide and cisplatin to trastuzumab, imatinib and PD-1 inhibitors, guiding procurement and pricing in lower-income countries.
- Orphan Drug Act 1983
The 1983 US law that pays companies to develop drugs for rare diseases with seven years of market exclusivity, tax credits and fee waivers, which is why so many cancer drugs are first approved for a rare subtype.
- Orphan drug designation
A status for drugs treating rare diseases (under 200,000 US patients, or under 5 in 10,000 in the EU) that gives the company tax credits, fee waivers and seven to ten years of market exclusivity, to make rare-disease drug development worthwhile.
- Hatch-Waxman Act 1984
The 1984 US law that created the modern generic drug: copies are approved on bioequivalence alone, brands get patent time restored for years lost in review, and the two sides fight it out through patent challenges with a 30-month pause.
- US regulatory exclusivity periods
Separate from patents, US law gives an approved drug fixed periods during which the FDA will not approve a copy: five years for a new chemical, three for new clinical studies, seven for an orphan indication, twelve for a biologic, plus six months for paediatric studies.
- 340B Drug Pricing Program
A US law that lets certain hospitals buy outpatient drugs, including cancer drugs, at deep discounts. Controversial because hospitals may bill insurers full price.
- TRIPS Agreement and the Doha Declaration
The 1994 world trade treaty that obliged every member country to grant twenty-year patents on medicines, and the 2001 declaration confirming that countries may still issue compulsory licences and protect public health; together they set the global terms on which cancer drugs are priced and copied.
- Regulation (EC) No 141/2000: EU orphan medicines
The EU's 2000 answer to the US Orphan Drug Act: ten years during which no similar medicine may be authorised for the same rare disease, plus fee reductions and scientific advice, for conditions affecting no more than 5 in 10,000 people.
- EU data and market protection (8+2+1)
In the EU a new medicine's trial data cannot be relied on by a generic or biosimilar for eight years, the copy cannot be sold for ten, and an eleventh year is added for a valuable new indication; it is the target of the 2023 reform.
- Medicare coverage with evidence development
Medicare's way of paying for a promising but uncertain test or treatment only for patients enrolled in a registry or study, used for PET scans in cancer from 2006 and now the frame for how Medicare covers gene panels and cell therapies.
- Supplementary protection certificate (EU)
The EU's version of patent term restoration: up to five extra years of protection for a medicine to make up for the years spent in trials and review, so that a cancer drug gets about fifteen years of protected sales after approval, plus six months for paediatric studies.
- Biologics Price Competition and Innovation Act 2010
The 2010 US law that created a route for copies of biologic drugs such as trastuzumab and rituximab, while giving the original twelve years of protection from those copies.
- Biosimilar
A biosimilar is a copy of a biologic drug such as trastuzumab, shown to be as safe and effective as the original once its patent expires, usually at a lower price.
- AMNOG (Germany, 2011)
Germany's 2011 law under which a new medicine is sold at the company's price from day one but must show, within six months, how much better it is than the existing standard; the verdict then drives a negotiated price that applies nationwide.
- Cancer Drugs Fund (England)
An NHS England fund that pays for promising cancer drugs while more evidence is collected, born in 2010 as a political fix for drugs NICE had refused and rebuilt in 2016 into a time-limited managed access scheme with a fixed budget.
- Nexavar compulsory licence (India, 2012)
In March 2012 India's patent office let Natco make a generic of Bayer's kidney and liver cancer drug sorafenib at about 3 percent of the branded price, paying a royalty, because Bayer had priced it beyond most Indians' reach; it remains the leading example of a compulsory licence on a cancer drug.
- Association for Molecular Pathology v. Myriad Genetics (2013)
The 2013 US Supreme Court ruling that human genes as they occur in nature cannot be patented, which ended one company's monopoly on BRCA testing and let hereditary cancer testing become cheap and widely available.
- Novartis v. Union of India (Glivec, 2013)
In April 2013 India's Supreme Court refused Novartis a patent on the crystal form of imatinib used in Glivec, ruling that a new form of a known drug must show improved therapeutic effect, a decision that kept Indian generics of the leukaemia drug legal and became the model for anti-evergreening laws elsewhere.
- China National Reimbursement Drug List negotiation and volume-based procurement
China's two price levers: an annual negotiation, since 2017, in which a new cancer drug wins national reimbursement only by cutting its price, often by half or more, and tenders since 2018 in which generic makers bid for guaranteed hospital volumes, collapsing prices of off-patent drugs.
- EU HTA Regulation (EU) 2021/2282: joint clinical assessments
From January 2025 every new cancer medicine in the EU gets one shared assessment of how well it works compared with existing treatments, done jointly by member states, so that each country's payer no longer repeats the clinical review, though each still decides on price.
- France: early access (accès précoce), formerly ATU
France pays for promising medicines before they are approved or reimbursed: the ATU system did this from 1994, and since July 2021 the Haute Autorité de Santé grants early access for presumed innovative drugs in serious diseases, with the company setting the price and repaying the difference later.
- State biomarker testing coverage laws
A wave of US state laws, starting in 2021, that require insurers regulated by the state and often Medicaid to pay for the tumour and inherited gene tests that decide which targeted drug a patient should get.
- Inflation Reduction Act 2022: Medicare drug price negotiation
The 2022 US law that for the first time lets Medicare negotiate prices for top-selling drugs, capped what older patients pay for prescriptions at 2,000 dollars a year, and exempted drugs approved only for rare diseases, an exemption widened in 2025.
- Innovative Medicines Fund (England)
A fund launched in 2022 that does for non-cancer medicines what the Cancer Drugs Fund does for cancer: pays for a promising but uncertain drug for a limited period while evidence is gathered, with the same budget of 340 million pounds.
- NICE technology appraisal methods (2022)
The rulebook NICE uses to decide whether the NHS in England should pay for a medicine: a cost per quality-adjusted life year usually between 20,000 and 30,000 pounds, with extra weight since 2022 for severe diseases in place of the old bonus for end-of-life cancer drugs.
- EU pharmaceutical package reform (2023 proposal)
The biggest rewrite of EU medicines law in twenty years, proposed in 2023: shorter default protection from generic competition with extensions for launching everywhere in the EU and for meeting unmet needs, faster assessments, and tighter orphan and paediatric rules, argued over by Parliament and Council since.
- BIOSECURE Act
Proposed US legislation restricting federally funded work with certain Chinese biotech service companies, which would affect where ADCs and sequencing get done.
Testing them (12)
Bottleneck: Trials enrol too few, too slowlyWho may be enrolled in a trial, on what consent, under which rules, and who must include children.
- Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments
The 1938 US law that makes a company prove a medicine is safe before selling it, and the 1962 amendments that added the requirement to prove it works, which is why every cancer drug approval rests on controlled trials.
- Declaration of Helsinki
The medical profession's own ethics code for research on people, adopted in 1964 and revised most recently in 2024, which every cancer trial protocol cites: informed consent, independent ethics review, the welfare of the participant above the interests of science, and limits on placebo controls.
- The Common Rule (45 CFR 46)
The US rules that require an ethics committee to approve research on people and require informed consent, written in 1991 and rewritten in 2018 so that a single committee can oversee a multi-site cancer trial and patients can give broad consent for future use of their samples.
- ICH good clinical practice (E6)
The international standard for how a clinical trial must be designed, run, recorded and reported so that regulators in the United States, Europe, Japan and now China will accept its data; the third version was adopted in 2025 to fit trials that use electronic records and run across many countries.
- Paediatric drug laws: BPCA and PREA
Two US laws, one a carrot and one a stick, that get new drugs studied in children: BPCA gives six extra months of exclusivity for doing requested paediatric studies, and PREA requires paediatric assessments, though until 2020 cancer drugs mostly escaped it.
- Regulation (EC) No 1901/2006: EU paediatric medicines
Since 2007 every new medicine in the EU must come with an agreed plan for studying it in children, or a waiver, and completing the plan earns six extra months of patent protection; a loophole let adult-cancer drugs skip children, which is now being closed.
- Clinical Trials Regulation (EU) No 536/2014 and CTIS
The EU rule, in force since January 2022, under which a cancer trial is submitted once through a single portal for all the countries it will run in, with results made public, replacing a 2001 directive that made every country's approval separate.
- 21st Century Cures Act
A 2016 US law that funded the Cancer Moonshot, created the RMAT designation for cell and gene therapies, told the FDA to work out how real-world data could support approvals, and made companies publish how patients can request unapproved drugs.
- RACE for Children Act
A US law that makes drug companies test new targeted cancer drugs in children whenever the drug's target matters in a childhood cancer, instead of letting them skip children because their cancers are rare.
- China Human Genetic Resources rules (2019, 2023)
Chinese rules that treat blood, tissue and genetic data from Chinese people as a national resource: foreign organisations cannot collect them, international collaborations need approval or filing, and exporting samples or sequence data needs a permit, which affects every global cancer trial with Chinese sites.
- India New Drugs and Clinical Trials Rules 2019
India's 2019 rules for approving new drugs and running trials set deadlines for the regulator, fixed compensation for trial injuries, and allowed waivers of local trials for drugs already approved abroad, a waiver widened in 2024 for cancer and orphan drugs.
- FDORA 2022 accelerated approval reforms
A December 2022 US law that lets the FDA insist the confirmatory trial for an accelerated approval is already running before the drug is approved, and gives it a quicker way to withdraw a drug when confirmation fails.
Protecting data and genes (10)
Bottleneck: Data silosHealth data, genetic information, gene patents and the rules for moving samples across borders.
- HIPAA (Health Insurance Portability and Accountability Act)
The 1996 US law whose privacy rules govern how hospitals, insurers and their contractors may use and share a patient's health records, including tumour genomics, and what must be stripped out before data can be used for research without consent.
- GINA (Genetic Information Nondiscrimination Act 2008)
A 2008 US law that stops health insurers and employers using your genetic test results against you, so a BRCA or Lynch syndrome result cannot raise your premiums or cost you a job; it does not cover life, disability or long-term care insurance.
- Association for Molecular Pathology v. Myriad Genetics (2013)
The 2013 US Supreme Court ruling that human genes as they occur in nature cannot be patented, which ended one company's monopoly on BRCA testing and let hereditary cancer testing become cheap and widely available.
- GDPR and health data (Regulation (EU) 2016/679)
The EU's 2016 data law, applied since May 2018, that treats health and genetic data as a special category needing a specific legal basis, gives people rights over their records, and shapes how cancer registries, biobanks and trials share data, including across borders.
- IVDR (EU In Vitro Diagnostic Regulation 2017/746)
Europe's rules for diagnostic tests, which since 2022 require most cancer tests to be certified by an independent body before they carry a CE mark, with deadlines for older tests running to 2029.
- UK Data Protection Act 2018 and health data law
The UK's data law, which keeps the EU's GDPR in domestic form and adds NHS-specific rules, so that cancer registries and research can use patient records under a public-interest basis, patients can opt out of secondary uses, and a 2025 Act loosened the consent rules for scientific research.
- China Human Genetic Resources rules (2019, 2023)
Chinese rules that treat blood, tissue and genetic data from Chinese people as a national resource: foreign organisations cannot collect them, international collaborations need approval or filing, and exporting samples or sequence data needs a permit, which affects every global cancer trial with Chinese sites.
- PIPL (China Personal Information Protection Law 2021)
China's 2021 privacy law, in force since November 2021, treats medical and health data as sensitive information requiring separate consent, and together with the Data Security Law restricts sending patient data out of China, which shapes every international cancer trial run there.
- FDA laboratory-developed test (LDT) rule
Most cancer tests in the US, including Galleri, Signatera and Oncotype DX, are 'lab-developed tests' overseen through lab standards rather than FDA approval; the FDA's 2024 attempt to change that was struck down in court in 2025.
- European Health Data Space Regulation (EU) 2025/327
A 2025 EU regulation that gives patients electronic access to their health records across the Union and creates national bodies that can grant researchers, regulators and companies permission to use anonymised or pseudonymised health data, phased in over the rest of the decade.
Preventing cancer (2)
Bottleneck: Prevention we already have is not deployedTobacco authority and minimum age laws, the levers that stop cancers before treatment is needed.
- Family Smoking Prevention and Tobacco Control Act 2009
The 2009 US law that finally gave the FDA power over tobacco products, the cause of roughly a third of cancer deaths, including authority to ban flavours, restrict marketing and set nicotine levels, though it may not ban cigarettes or nicotine outright.
- Tobacco 21
Since December 2019 it has been illegal across the United States to sell tobacco or vaping products to anyone under 21, a rule that started in one Massachusetts town and spread state by state, aimed at the years when most smokers start.
By jurisdiction
Each heading links to the regulator or assessment body that applies the laws. Approvals by region are on the regional approvals page.
United States (30)
FDA Oncology Center of Excellence- Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments
The 1938 US law that makes a company prove a medicine is safe before selling it, and the 1962 amendments that added the requirement to prove it works, which is why every cancer drug approval rests on controlled trials.
- Orphan Drug Act 1983
The 1983 US law that pays companies to develop drugs for rare diseases with seven years of market exclusivity, tax credits and fee waivers, which is why so many cancer drugs are first approved for a rare subtype.
- Orphan drug designation
A status for drugs treating rare diseases (under 200,000 US patients, or under 5 in 10,000 in the EU) that gives the company tax credits, fee waivers and seven to ten years of market exclusivity, to make rare-disease drug development worthwhile.
- Hatch-Waxman Act 1984
The 1984 US law that created the modern generic drug: copies are approved on bioequivalence alone, brands get patent time restored for years lost in review, and the two sides fight it out through patent challenges with a 30-month pause.
- US regulatory exclusivity periods
Separate from patents, US law gives an approved drug fixed periods during which the FDA will not approve a copy: five years for a new chemical, three for new clinical studies, seven for an orphan indication, twelve for a biologic, plus six months for paediatric studies.
- Expanded access (compassionate use)
The regulated way a seriously ill patient who cannot join a trial can get an unapproved drug: the doctor asks the company, the company agrees, and the regulator reviews the request, usually within days for a single patient.
- The Common Rule (45 CFR 46)
The US rules that require an ethics committee to approve research on people and require informed consent, written in 1991 and rewritten in 2018 so that a single committee can oversee a multi-site cancer trial and patients can give broad consent for future use of their samples.
- 340B Drug Pricing Program
A US law that lets certain hospitals buy outpatient drugs, including cancer drugs, at deep discounts. Controversial because hospitals may bill insurers full price.
- Accelerated approval
FDA approval based on early evidence (like tumour shrinkage) on condition that a confirmatory trial follows.
- HIPAA (Health Insurance Portability and Accountability Act)
The 1996 US law whose privacy rules govern how hospitals, insurers and their contractors may use and share a patient's health records, including tumour genomics, and what must be stripped out before data can be used for research without consent.
- Fast Track and RMAT designations
Two of the FDA's expedited programmes: Fast Track gives drugs for serious unmet needs more frequent FDA meetings and rolling review; RMAT is the equivalent for cell and gene therapies. Neither guarantees approval or changes the evidence standard.
- Paediatric drug laws: BPCA and PREA
Two US laws, one a carrot and one a stick, that get new drugs studied in children: BPCA gives six extra months of exclusivity for doing requested paediatric studies, and PREA requires paediatric assessments, though until 2020 cancer drugs mostly escaped it.
- Medicare coverage with evidence development
Medicare's way of paying for a promising but uncertain test or treatment only for patients enrolled in a registry or study, used for PET scans in cancer from 2006 and now the frame for how Medicare covers gene panels and cell therapies.
- Abigail Alliance v. von Eschenbach (2007)
A 2007 US appeals court ruling that terminally ill patients have no constitutional right to buy unapproved drugs after phase 1, which pushed the access movement toward legislation and eventually the Right to Try Act.
- GINA (Genetic Information Nondiscrimination Act 2008)
A 2008 US law that stops health insurers and employers using your genetic test results against you, so a BRCA or Lynch syndrome result cannot raise your premiums or cost you a job; it does not cover life, disability or long-term care insurance.
- Family Smoking Prevention and Tobacco Control Act 2009
The 2009 US law that finally gave the FDA power over tobacco products, the cause of roughly a third of cancer deaths, including authority to ban flavours, restrict marketing and set nicotine levels, though it may not ban cigarettes or nicotine outright.
- Biologics Price Competition and Innovation Act 2010
The 2010 US law that created a route for copies of biologic drugs such as trastuzumab and rituximab, while giving the original twelve years of protection from those copies.
- Biosimilar
A biosimilar is a copy of a biologic drug such as trastuzumab, shown to be as safe and effective as the original once its patent expires, usually at a lower price.
- Breakthrough Therapy / Priority Review / Priority Voucher
Breakthrough Therapy, Priority Review and the Priority Voucher are FDA fast lanes for drugs that look substantially better than existing options.
- FDASIA 2012 and the origins of the expedited programmes
The 2012 US law that created Breakthrough Therapy designation and made the paediatric study laws permanent, sitting on top of the 1992 user-fee law that gave the FDA review deadlines and the 1997 law that created Fast Track.
- Association for Molecular Pathology v. Myriad Genetics (2013)
The 2013 US Supreme Court ruling that human genes as they occur in nature cannot be patented, which ended one company's monopoly on BRCA testing and let hereditary cancer testing become cheap and widely available.
- 21st Century Cures Act
A 2016 US law that funded the Cancer Moonshot, created the RMAT designation for cell and gene therapies, told the FDA to work out how real-world data could support approvals, and made companies publish how patients can request unapproved drugs.
- RACE for Children Act
A US law that makes drug companies test new targeted cancer drugs in children whenever the drug's target matters in a childhood cancer, instead of letting them skip children because their cancers are rare.
- Right to Try Act 2018 and state right-to-try laws
A 2018 US law letting patients with life-threatening illnesses ask a company directly for a drug that has passed phase 1 without going through the FDA; companies still decide, and in practice most access happens through the older expanded access route.
- Tobacco 21
Since December 2019 it has been illegal across the United States to sell tobacco or vaping products to anyone under 21, a rule that started in one Massachusetts town and spread state by state, aimed at the years when most smokers start.
- State biomarker testing coverage laws
A wave of US state laws, starting in 2021, that require insurers regulated by the state and often Medicaid to pay for the tumour and inherited gene tests that decide which targeted drug a patient should get.
- FDORA 2022 accelerated approval reforms
A December 2022 US law that lets the FDA insist the confirmatory trial for an accelerated approval is already running before the drug is approved, and gives it a quicker way to withdraw a drug when confirmation fails.
- Inflation Reduction Act 2022: Medicare drug price negotiation
The 2022 US law that for the first time lets Medicare negotiate prices for top-selling drugs, capped what older patients pay for prescriptions at 2,000 dollars a year, and exempted drugs approved only for rare diseases, an exemption widened in 2025.
- BIOSECURE Act
Proposed US legislation restricting federally funded work with certain Chinese biotech service companies, which would affect where ADCs and sequencing get done.
- FDA laboratory-developed test (LDT) rule
Most cancer tests in the US, including Galleri, Signatera and Oncotype DX, are 'lab-developed tests' overseen through lab standards rather than FDA approval; the FDA's 2024 attempt to change that was struck down in court in 2025.
European Union (12)
European Medicines Agency- Regulation (EC) No 141/2000: EU orphan medicines
The EU's 2000 answer to the US Orphan Drug Act: ten years during which no similar medicine may be authorised for the same rare disease, plus fee reductions and scientific advice, for conditions affecting no more than 5 in 10,000 people.
- EU data and market protection (8+2+1)
In the EU a new medicine's trial data cannot be relied on by a generic or biosimilar for eight years, the copy cannot be sold for ten, and an eleventh year is added for a valuable new indication; it is the target of the 2023 reform.
- Regulation (EC) No 726/2004: the EU centralised procedure
The 2004 EU regulation under which every new cancer medicine is assessed once by the European Medicines Agency and authorised for all member states by the European Commission, and which also carries the rules for conditional authorisation and compassionate use.
- Conditional marketing authorisation (EU)
The European (and Chinese) counterpart of accelerated approval: a drug for an unmet need is authorised on less complete data with specific obligations to deliver confirmatory results, renewed yearly until converted to standard approval.
- Regulation (EC) No 1901/2006: EU paediatric medicines
Since 2007 every new medicine in the EU must come with an agreed plan for studying it in children, or a waiver, and completing the plan earns six extra months of patent protection; a loophole let adult-cancer drugs skip children, which is now being closed.
- Supplementary protection certificate (EU)
The EU's version of patent term restoration: up to five extra years of protection for a medicine to make up for the years spent in trials and review, so that a cancer drug gets about fifteen years of protected sales after approval, plus six months for paediatric studies.
- Clinical Trials Regulation (EU) No 536/2014 and CTIS
The EU rule, in force since January 2022, under which a cancer trial is submitted once through a single portal for all the countries it will run in, with results made public, replacing a 2001 directive that made every country's approval separate.
- GDPR and health data (Regulation (EU) 2016/679)
The EU's 2016 data law, applied since May 2018, that treats health and genetic data as a special category needing a specific legal basis, gives people rights over their records, and shapes how cancer registries, biobanks and trials share data, including across borders.
- IVDR (EU In Vitro Diagnostic Regulation 2017/746)
Europe's rules for diagnostic tests, which since 2022 require most cancer tests to be certified by an independent body before they carry a CE mark, with deadlines for older tests running to 2029.
- EU HTA Regulation (EU) 2021/2282: joint clinical assessments
From January 2025 every new cancer medicine in the EU gets one shared assessment of how well it works compared with existing treatments, done jointly by member states, so that each country's payer no longer repeats the clinical review, though each still decides on price.
- EU pharmaceutical package reform (2023 proposal)
The biggest rewrite of EU medicines law in twenty years, proposed in 2023: shorter default protection from generic competition with extensions for launching everywhere in the EU and for meeting unmet needs, faster assessments, and tighter orphan and paediatric rules, argued over by Parliament and Council since.
- European Health Data Space Regulation (EU) 2025/327
A 2025 EU regulation that gives patients electronic access to their health records across the Union and creates national bodies that can grant researchers, regulators and companies permission to use anonymised or pseudonymised health data, phased in over the rest of the decade.
United Kingdom (6)
Medicines and Healthcare products Regulatory Agency- Cancer Drugs Fund (England)
An NHS England fund that pays for promising cancer drugs while more evidence is collected, born in 2010 as a political fix for drugs NICE had refused and rebuilt in 2016 into a time-limited managed access scheme with a fixed budget.
- UK Data Protection Act 2018 and health data law
The UK's data law, which keeps the EU's GDPR in domestic form and adds NHS-specific rules, so that cancer registries and research can use patient records under a public-interest basis, patients can opt out of secondary uses, and a 2025 Act loosened the consent rules for scientific research.
- ILAP (Innovative Licensing and Access Pathway)
The UK's post-Brexit scheme, launched in 2021 and refreshed in 2025, that brings the medicines regulator, NICE and the NHS together early in a drug's development so that licensing and the decision to pay for it can happen close together.
- Medicines and Medical Devices Act 2021
The 2021 UK law, passed after Brexit, that gives ministers power to rewrite the rules for licensing medicines, running trials and regulating devices without new primary legislation, and that created a patient safety commissioner.
- Innovative Medicines Fund (England)
A fund launched in 2022 that does for non-cancer medicines what the Cancer Drugs Fund does for cancer: pays for a promising but uncertain drug for a limited period while evidence is gathered, with the same budget of 340 million pounds.
- NICE technology appraisal methods (2022)
The rulebook NICE uses to decide whether the NHS in England should pay for a medicine: a cost per quality-adjusted life year usually between 20,000 and 30,000 pounds, with extra weight since 2022 for severe diseases in place of the old bonus for end-of-life cancer drugs.
Germany (1)
Gemeinsamer Bundesausschuss / IQWiG- AMNOG (Germany, 2011)
Germany's 2011 law under which a new medicine is sold at the company's price from day one but must show, within six months, how much better it is than the existing standard; the verdict then drives a negotiated price that applies nationwide.
France (1)
Haute Autorité de Santé- France: early access (accès précoce), formerly ATU
France pays for promising medicines before they are approved or reimbursed: the ATU system did this from 1994, and since July 2021 the Haute Autorité de Santé grants early access for presumed innovative drugs in serious diseases, with the company setting the price and repaying the difference later.
- Sakigake designation (Japan)
Japan's fast lane for innovative medicines developed there first: a designated drug gets priority consultation, a six-month review instead of twelve, and a price premium, in return for early development in Japan.
- Japan conditional early approval and time-limited approval
Japan can approve a medicine for a serious disease on early data when a confirmatory trial would be hard to run, on condition that evidence is gathered after launch; for cell and tissue products a 2014 law allows a time-limited approval that must be confirmed within seven years.
- China National Reimbursement Drug List negotiation and volume-based procurement
China's two price levers: an annual negotiation, since 2017, in which a new cancer drug wins national reimbursement only by cutting its price, often by half or more, and tenders since 2018 in which generic makers bid for guaranteed hospital volumes, collapsing prices of off-patent drugs.
- China Drug Administration Law (2019) and expedited pathways
China rewrote its drug law in 2019 and its registration rules in 2020, writing in priority review, conditional approval, breakthrough designation and acceptance of foreign trial data, which turned the world's slowest big regulator into one that approves cancer drugs within months of the FDA.
- China Human Genetic Resources rules (2019, 2023)
Chinese rules that treat blood, tissue and genetic data from Chinese people as a national resource: foreign organisations cannot collect them, international collaborations need approval or filing, and exporting samples or sequence data needs a permit, which affects every global cancer trial with Chinese sites.
- PIPL (China Personal Information Protection Law 2021)
China's 2021 privacy law, in force since November 2021, treats medical and health data as sensitive information requiring separate consent, and together with the Data Security Law restricts sending patient data out of China, which shapes every international cancer trial run there.
- Nexavar compulsory licence (India, 2012)
In March 2012 India's patent office let Natco make a generic of Bayer's kidney and liver cancer drug sorafenib at about 3 percent of the branded price, paying a royalty, because Bayer had priced it beyond most Indians' reach; it remains the leading example of a compulsory licence on a cancer drug.
- Novartis v. Union of India (Glivec, 2013)
In April 2013 India's Supreme Court refused Novartis a patent on the crystal form of imatinib used in Glivec, ruling that a new form of a known drug must show improved therapeutic effect, a decision that kept Indian generics of the leukaemia drug legal and became the model for anti-evergreening laws elsewhere.
- India New Drugs and Clinical Trials Rules 2019
India's 2019 rules for approving new drugs and running trials set deadlines for the regulator, fixed compensation for trial injuries, and allowed waivers of local trials for drugs already approved abroad, a waiver widened in 2024 for cancer and orphan drugs.
International (5)
World Health Organization Cancer Programme- Declaration of Helsinki
The medical profession's own ethics code for research on people, adopted in 1964 and revised most recently in 2024, which every cancer trial protocol cites: informed consent, independent ethics review, the welfare of the participant above the interests of science, and limits on placebo controls.
- WHO Essential Medicines List for cancer
The World Health Organization's list of medicines every health system should provide, which now includes about 60 cancer drugs from cyclophosphamide and cisplatin to trastuzumab, imatinib and PD-1 inhibitors, guiding procurement and pricing in lower-income countries.
- TRIPS Agreement and the Doha Declaration
The 1994 world trade treaty that obliged every member country to grant twenty-year patents on medicines, and the 2001 declaration confirming that countries may still issue compulsory licences and protect public health; together they set the global terms on which cancer drugs are priced and copied.
- ICH good clinical practice (E6)
The international standard for how a clinical trial must be designed, run, recorded and reported so that regulators in the United States, Europe, Japan and now China will accept its data; the third version was adopted in 2025 to fit trials that use electronic records and run across many countries.
- Project Orbis
Project Orbis is a scheme where the FDA and partner regulators (Australia, Canada, UK, Switzerland, Singapore, Brazil, Israel) review a cancer drug at the same time.
By instrument
A statute is passed by a legislature; a regulation is made by a government or agency under one; guidance says how an agency reads them; a scheme is an administrative programme; a court ruling settles what they mean.
statute26
- 1938Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris AmendmentsUnited States
- 1983Orphan Drug Act 1983United States
- 1984Hatch-Waxman Act 1984United States
- 1984US regulatory exclusivity periodsUnited States
- 1992340B Drug Pricing ProgramUnited States
- 1996HIPAA (Health Insurance Portability and Accountability Act)United States
- 2002Paediatric drug laws: BPCA and PREAUnited States
- 2008GINA (Genetic Information Nondiscrimination Act 2008)United States
- 2009Family Smoking Prevention and Tobacco Control Act 2009United States
- 2010Biologics Price Competition and Innovation Act 2010United States
- 2011AMNOG (Germany, 2011)Germany
- 2012FDASIA 2012 and the origins of the expedited programmesUnited States
- 201621st Century Cures ActUnited States
- 2017Japan conditional early approval and time-limited approvalJapan
- 2017RACE for Children ActUnited States
- 2018Right to Try Act 2018 and state right-to-try lawsUnited States
- 2018UK Data Protection Act 2018 and health data lawUnited Kingdom
- 2019China Drug Administration Law (2019) and expedited pathwaysChina
- 2019Tobacco 21United States
- 2021France: early access (accès précoce), formerly ATUFrance
- 2021Medicines and Medical Devices Act 2021United Kingdom
- 2021PIPL (China Personal Information Protection Law 2021)China
- 2021State biomarker testing coverage lawsUnited States
- 2022FDORA 2022 accelerated approval reformsUnited States
- 2022Inflation Reduction Act 2022: Medicare drug price negotiationUnited States
- 2024BIOSECURE ActUnited States
regulation18
- 1987Expanded access (compassionate use)United States
- 1991The Common Rule (45 CFR 46)United States
- 1992Accelerated approvalUnited States
- 2000Regulation (EC) No 141/2000: EU orphan medicinesEuropean Union
- 2004EU data and market protection (8+2+1)European Union
- 2004Regulation (EC) No 726/2004: the EU centralised procedureEuropean Union
- 2006Conditional marketing authorisation (EU)European Union
- 2006Regulation (EC) No 1901/2006: EU paediatric medicinesEuropean Union
- 2009Supplementary protection certificate (EU)European Union
- 2014Clinical Trials Regulation (EU) No 536/2014 and CTISEuropean Union
- 2016GDPR and health data (Regulation (EU) 2016/679)European Union
- 2017IVDR (EU In Vitro Diagnostic Regulation 2017/746)European Union
- 2019China Human Genetic Resources rules (2019, 2023)China
- 2019India New Drugs and Clinical Trials Rules 2019India
- 2021EU HTA Regulation (EU) 2021/2282: joint clinical assessmentsEuropean Union
- 2023EU pharmaceutical package reform (2023 proposal)European Union
- 2024FDA laboratory-developed test (LDT) ruleUnited States
- 2025European Health Data Space Regulation (EU) 2025/327European Union
guidance8
- 1977WHO Essential Medicines List for cancerInternational
- 1983Orphan drug designationUnited States
- 1996ICH good clinical practice (E6)International
- 1997Fast Track and RMAT designationsUnited States
- 2006Medicare coverage with evidence developmentUnited States
- 2010BiosimilarUnited States
- 2012Breakthrough Therapy / Priority Review / Priority VoucherUnited States
- 2022NICE technology appraisal methods (2022)United Kingdom
court ruling4
scheme6
- 2011Cancer Drugs Fund (England)United Kingdom
- 2015Sakigake designation (Japan)Japan
- 2018China National Reimbursement Drug List negotiation and volume-based procurementChina
- 2019Project OrbisInternational
- 2021ILAP (Innovative Licensing and Access Pathway)United Kingdom
- 2022Innovative Medicines Fund (England)United Kingdom
treaty1
declaration1
Timeline
Year of enactment, adoption or judgment. Dated product-level events (filings, approvals, withdrawals) are on the regulatory timeline.
- 1930s
- 1960s
- 1970s
- 1980s
- 1990s
- 1991regulationThe Common Rule (45 CFR 46)United States
- 1992statute340B Drug Pricing ProgramUnited States
- 1992regulationAccelerated approvalUnited States
- 1994treatyTRIPS Agreement and the Doha DeclarationInternational
- 1996statuteHIPAA (Health Insurance Portability and Accountability Act)United States
- 1996guidanceICH good clinical practice (E6)International
- 1997guidanceFast Track and RMAT designationsUnited States
- 2000s
- 2000regulationRegulation (EC) No 141/2000: EU orphan medicinesEuropean Union
- 2002statutePaediatric drug laws: BPCA and PREAUnited States
- 2004regulationEU data and market protection (8+2+1)European Union
- 2004regulationRegulation (EC) No 726/2004: the EU centralised procedureEuropean Union
- 2006regulationConditional marketing authorisation (EU)European Union
- 2006guidanceMedicare coverage with evidence developmentUnited States
- 2006regulationRegulation (EC) No 1901/2006: EU paediatric medicinesEuropean Union
- 2007court rulingAbigail Alliance v. von Eschenbach (2007)United States
- 2008statuteGINA (Genetic Information Nondiscrimination Act 2008)United States
- 2009statuteFamily Smoking Prevention and Tobacco Control Act 2009United States
- 2009regulationSupplementary protection certificate (EU)European Union
- 2010s
- 2010statuteBiologics Price Competition and Innovation Act 2010United States
- 2010guidanceBiosimilarUnited States
- 2011statuteAMNOG (Germany, 2011)Germany
- 2011schemeCancer Drugs Fund (England)United Kingdom
- 2012guidanceBreakthrough Therapy / Priority Review / Priority VoucherUnited States
- 2012statuteFDASIA 2012 and the origins of the expedited programmesUnited States
- 2012court rulingNexavar compulsory licence (India, 2012)India
- 2013court rulingAssociation for Molecular Pathology v. Myriad Genetics (2013)United States
- 2013court rulingNovartis v. Union of India (Glivec, 2013)India
- 2014regulationClinical Trials Regulation (EU) No 536/2014 and CTISEuropean Union
- 2015schemeSakigake designation (Japan)Japan
- 2016statute21st Century Cures ActUnited States
- 2016regulationGDPR and health data (Regulation (EU) 2016/679)European Union
- 2017regulationIVDR (EU In Vitro Diagnostic Regulation 2017/746)European Union
- 2017statuteJapan conditional early approval and time-limited approvalJapan
- 2017statuteRACE for Children ActUnited States
- 2018schemeChina National Reimbursement Drug List negotiation and volume-based procurementChina
- 2018statuteRight to Try Act 2018 and state right-to-try lawsUnited States
- 2018statuteUK Data Protection Act 2018 and health data lawUnited Kingdom
- 2019statuteChina Drug Administration Law (2019) and expedited pathwaysChina
- 2019regulationChina Human Genetic Resources rules (2019, 2023)China
- 2019regulationIndia New Drugs and Clinical Trials Rules 2019India
- 2019schemeProject OrbisInternational
- 2019statuteTobacco 21United States
- 2020s
- 2021regulationEU HTA Regulation (EU) 2021/2282: joint clinical assessmentsEuropean Union
- 2021statuteFrance: early access (accès précoce), formerly ATUFrance
- 2021schemeILAP (Innovative Licensing and Access Pathway)United Kingdom
- 2021statuteMedicines and Medical Devices Act 2021United Kingdom
- 2021statutePIPL (China Personal Information Protection Law 2021)China
- 2021statuteState biomarker testing coverage lawsUnited States
- 2022statuteFDORA 2022 accelerated approval reformsUnited States
- 2022statuteInflation Reduction Act 2022: Medicare drug price negotiationUnited States
- 2022schemeInnovative Medicines Fund (England)United Kingdom
- 2022guidanceNICE technology appraisal methods (2022)United Kingdom
- 2023regulationEU pharmaceutical package reform (2023 proposal)European Union
- 2024statuteBIOSECURE ActUnited States
- 2024regulationFDA laboratory-developed test (LDT) ruleUnited States
- 2025regulationEuropean Health Data Space Regulation (EU) 2025/327European Union
How to read an entry
Every law page opens with the jurisdiction, the instrument, the year and a link to the primary text (Congress.gov and the FDA, EUR-Lex and the EMA, legislation.gov.uk and NICE, the PMDA, the NMPA and the CDSCO). Then what it changed for patients and for companies, and the arguments for and against it. Dates and numbers appear only where a source is certain; where none is, the entry says so.
Terms that predate this page, such as accelerated approval, conditional marketing authorisation and orphan designation, were given the same opening paragraph and now link to the statutes behind them.
Where the laws bite
The exclusivity timeline applies Hatch-Waxman, the BPCIA and the supplementary protection certificate to each product. HTA decisions are NICE, G-BA and PBAC verdicts made under the methods and statutes here. Paying for care in the US and NHS coverage show what the Inflation Reduction Act, 340B and the Cancer Drugs Fund mean for a given drug. Cutting cancer care costs pairs each cost driver with the ideas that could do more.
Add a law in src/data/law-wave.ts: a glossary term in the Regulation & policy category plus a row in LAW_INDEX giving its jurisdiction, year, instrument and themes.