law

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.