🔍💊 New regulatory framework for colorectal cancer screening: easier access to kits in pharmacies, with nurses or online, strengthened follow‑up of positive tests and mandatory accreditation of laboratories. A major step to reduce mortality from colorectal cancer.
Source : 📒 Arrêté du 10 mars 2026 modifiant l'arrêté du 16 janvier 2024 relatif aux programmes de dépistages organisés des cancers
📜🔗LIEN
1. ANALYTICAL SUMMARY
Context
and challenges of organised screening
This ministerial order updates
the specifications of the national organised colorectal cancer
screening programme for people aged 50 to 74 at average risk. It
covers the whole pathway: individual invitations by the health
insurance funds every two years, distribution of immunochemical
faecal occult blood test kits by health professionals (doctors,
community pharmacists, registered nurses) or via online ordering,
analysis by accredited medical laboratories and follow‑up of
people with positive tests by the Regional Cancer Screening
Coordination Centres (CRCDC). The document specifies eligibility
criteria, excludes people at increased risk (personal or family
history) who require colonoscopic surveillance, and defines reminder
procedures to improve participation, currently 30.7% in 2024‑2025,
well below the European benchmark of 45%.
Operational
contributions for frontline actors
The order provides a detailed
regulatory framework for all professionals involved: GPs,
gynaecologists, gastroenterologists, pharmacists, nurses, medical
biologists and CRCDC managers. It clarifies each actor’s role in
assessing eligibility, informing about benefits and limitations of
the test, ensuring traceability of kit delivery, analysing samples
under strict accreditation standards (ISO 15189), and actively
following up positive results to secure colonoscopy. The order sets
precise timelines (results sent within 2 working days after receipt,
data transfer to CRCDC within 48 hours), quality requirements
(sensitivity 70%, specificity 96‑98%, configurable positivity
threshold), and a secure, GDPR‑compliant information system for
data sharing between laboratories, CRCDCs, physicians and screened
individuals.
2. KEY POINTS OF THE DOCUMENT
1.
Target population and strict eligibility criteria
Organised screening targets
women and men aged 50 to 74 at average risk, i.e. with no symptoms,
no personal history of adenoma, colorectal cancer or chronic
inflammatory bowel disease, and no first‑degree family history
of adenoma or colorectal cancer. People at increased risk (personal
history of colorectal cancer, inflammatory bowel disease, family
history of cancer or adenoma, polyposis, Lynch syndrome) are excluded
from the programme and referred for colonoscopic surveillance or
oncogenetic consultation. Individuals who have had a complete
colonoscopy are ineligible for five years; those with CT colonography
only or incomplete colonoscopy followed by CT colonography are
ineligible for two years, subject to medical opinion.
2.
Diversified access routes to screening kits
Eligible people receive a
personal invitation from their health insurance fund every two years,
encouraging them to pick up a kit from their doctor (GP,
gynaecologist, gastroenterologist or physician at a health
examination centre), from a community pharmacy, from a registered
nurse or to order it directly online. Delivery by a doctor does not
require a dedicated visit but is done during routine consultations. A
structured reminder system is planned: two reminders within a maximum
of 12 months, with a screening kit enclosed with the second reminder
for people who participated in any of the previous three screening
rounds. A text or email reminder is sent to individuals who ordered a
kit online but did not return it to the laboratory within one month.
3.
Central role of health professionals in risk assessment and
information
The professional handing over
the kit must assess the person’s risk level and eligibility, based
on personal and family history. If the person is ineligible, the
doctor proposes alternative screening or surveillance (referral to a
gastroenterologist or oncogenetic consultation), whereas pharmacists
and nurses refer to the GP. The professional explains the benefits
and limitations of screening, possible follow‑up steps and what
to do if the test is positive. They ensure that the person
understands how to use the kit and send the sample, check correct
identification on pre‑printed labels (name, date of birth,
unique health insurance identifier) and can help complete the form if
needed. During subsequent consultations, they again raise the issue
with patients who have not yet done the test.
4.
Technical and quality requirements for medical laboratories
Only medical laboratories
accredited to ISO 15189 by COFRAC or an equivalent European body and
selected through a national public tender led by the National Health
Insurance Fund (CNAM) may perform the analyses. They use a
quantitative immunochemical faecal occult blood test based on a
single self‑sample, with an adjustable positivity threshold (in
France typically 150 ng Hb/ml, approx. 30 µg Hb/g of faeces).
Expected performance is 70% sensitivity, 96‑98% specificity,
positive predictive value at least 8‑10% for cancers and 40%
for cancers plus advanced adenomas, with an overall positivity rate
between 3% and 6%. Laboratories must respect strict timelines:
analysis within 7 days after sampling, dispatch of results within 2
working days after receipt, transfer of data to CRCDCs within 48
working hours in a secure electronic format.
5.
Strengthened follow‑up of people with positive results by
CRCDCs
CRCDCs monitor all screened
individuals according to a national guideline developed by the French
National Cancer Institute (INCa). For people with a positive result
(3.3% of tests in 2024‑2025), CRCDCs actively check whether
colonoscopy has been performed, via the physician receiving the
results, gastroenterologists or directly with the person. Reminder
letters are sent to patients with uninvestigated positive tests in
the year following the result, after consulting the identified
physician. All contacts (letters, phone calls) are systematically
logged. If after two years no follow‑up data can be obtained
despite multiple reminders, monitoring is stopped but the person is
reinvited in the next round. Colonoscopy refusals are specifically
documented to avoid unnecessary reminders, while undecided persons
are still encouraged by their doctors, supported by a final reminder
sent by the CRCDC.
3. ACTIONABLE PATHWAYS FOR LOCAL ACTORS
1.
Systematically assess screening eligibility during routine
consultations
General practitioners,
gynaecologists and other physicians can systematically ask patients
aged 50 to 74 about personal and family history of colorectal cancer,
adenomas or inflammatory bowel disease, to distinguish average‑risk
individuals eligible for organised screening from higher‑risk
patients needing specialised surveillance. They should use the list
of eligible patients provided by health insurance to target
discussions during consultations and opportunistic visits. This
proactive approach can help raise the participation rate, currently
30.7%, still well below the 45% European target.
2.
Train pharmacists and nurses in first‑line counselling and
referral
Provide dedicated training for
community pharmacists and registered nurses on eligibility
assessment, correct use of the kit, key messages on benefits and
limitations of the test, and referral to GPs when eligibility is
uncertain or when risk is increased. These frontline professionals,
authorised to distribute kits since 2022, are crucial for improving
access to screening, especially for people without a regular doctor
or with limited access to primary care. CRCDCs can supply them with
kits and organise local training and awareness sessions.
3.
Develop targeted communication to low‑participation groups
CRCDCs, in partnership with
Regional Health Agencies (ARS) and health insurance, can design
tailored campaigns for groups with low participation: men, people in
precarious situations, residents of deprived neighbourhoods, and
people with low health literacy. Use varied formats (short videos
showing how to use the kit, testimonials, outreach stands in
community venues, collaborations with patient associations), with
simple messages about test effectiveness (detects 70% of cancers,
more cancers and advanced adenomas than the previous test) and ease
of use (single sample, pre‑paid return envelope). Always
highlight new access routes (pharmacy, nurse, online order).
4.
Strengthen follow‑up of positive tests via gastroenterology
networks
CRCDCs can formalise agreements
with local networks of gastroenterologists (hospital and private) to
improve documentation of colonoscopies undertaken after positive
tests and reduce loss to follow‑up. Use standardised reporting
templates (INCa colonoscopy and pathology forms) to feed CRCDC
information systems. Organise coordination meetings between CRCDCs,
GPs and gastroenterologists to identify local barriers (waiting
times, patient reluctance, comorbidities) and design tailored
solutions (fast‑track slots, specific support for vulnerable
patients).
5.
Improve traceability and interoperability of information systems
Laboratories and CRCDCs must
ensure that their IT systems comply with national INCa specifications
for automated, secure data exchange (test results, kit delivery
channels, follow‑up after positive tests). They should verify
that data transfers meet current standards (structured electronic
formats, compliant barcodes or data matrix codes, GDPR and French
data protection law requirements). Staff need training in using these
tools, and regular data quality checks are required to avoid
misidentification and duplicates. This traceability is essential for
programme evaluation and regional management by ARSs
🔍➕ Pour plus d'informations, voir les articles référencés par "Pratiques en Santé" sur le thème des politiques nationales ➡️🔗