Please note that we do not accept responsibility or liability for any external websites that you may access via a link from this website. External websites will have their own privacy policies, which you should read.
Who are we?
ConcePTION is a project funded by the Innovative Medicines Initiative, a public private partnership. The project was launched in April 2019.
We believe that we have an important societal obligation to reduce radically and rapidly uncertainty about the effects of medication used during pregnancy and breastfeeding to benefit women in making informed decisions about medications used before, during and after pregnancy.
The ConcePTION project is building much-needed knowledge for women and health care professionals.
Why do we need your information?
To submit information on adverse reactions and/or medication exposure during pregnancy and breastfeeding we require certain personal information. We ask for the reporter’s name and contact details so that we can get in touch if we need more information. We also require health and demographic details (such as age, sex, ethnicity etc) of the person affected by the incident to understand the impact on different populations.
The information you provide will be kept safely, securely and confidentially. We will not share personal identifiers with any person outside IMI ConcePTION without your explicit consent, unless we are required to do so by law. You can also ask someone else to send a report in about a suspected side effect if you do not wish to give us your name.
What personal data do we collect?
When you visit the website or app
Our cookies capture certain online identifiers and information when you visit our IMI ConcePTION website or use the IMI ConcePTION app.
When you register for an account
You may register with the IMI ConcePTION app by providing your name and contact details, but registering is not essential. This information is requested for your convenience as registering will enable multiple report submissions without requiring multiple entry of your details. Once registered, you can also view previously submitted reports.
IMI ConcePTION may contact registered users about their reports. We will not pass your personal data to other organizations for commercial or any other use except as identified in this policy.
When you report an adverse reaction and/or medication exposure
We encourage reports from the individual affected, their friends and relatives, healthcare professionals and manufacturers – anyone may submit a report on their own or someone else’s behalf.
We collect information on the reporter and the individual affected; this will be the same person if you are reporting about yourself.
We collect the following personal information about the reporter:
- First name, last name
- Contact details; email address, telephone number
- Job title and organization details if the reporter is a healthcare professional or manufacturer representative
- IP address
We collect the following personal information and special category information about the individual affected:
- We require at least one of the following characteristics: initials, age, sex, weight, height ethnicity (optional)
- Information about the suspected product and a description of the adverse incident Health data, including medical history and medications
Our lawful basis for processing your personal data is GDPR Article 6(1)(e), which allows us to process personal data when this is necessary to perform our research.
Safety case reports require some information about the individual affected. If you are submitting a report about yourself, the information will relate to you and include some special category personal data, such as information about your health or ethnicity. The lawful bases we rely on to process special category personal data are Article 9(2)(i) of the GDPR and Schedule 1 part 1(3) of the DPA, both of which enable us to process such information when it is necessary for reasons of the public interest in the area of public health.
Where we share patient safety data for scientific or public health research purposes, we rely on GDPR Article 9(2)(j) as our lawful basis for processing special category personal data and Schedule 1 part 1(4) of the DPA. These bases permit us to process personal data for these purposes where it is in the public interest, subject to appropriate safeguards to protect your rights and freedoms.
Sharing your information
We will not share your information with any third parties for the purposes of direct marketing.
We do not share your identity with any person outside IMI ConcePTION without your explicit consent, unless we are required or permitted to do so by law. Examples include if we receive a court order to do so or if you are a healthcare professional reporting an adverse incident relating to a medical device, further details of which can be found below. Exceptionally, we may share this where we have established a lawful basis for sharing personal data and can demonstrate that it is both necessary and proportionate to do so.
We may receive requests for IMI ConcePTION report data under the Freedom of Information Act. While we are legally obliged to provide some of the requested information, we only provide high-level summary information with all person-identifiable data excluded.
We sometimes provide IMI ConcePTION data for scientific or public health research purposes.
If the situation arises, we would only share confidential patient information if we were satisfied that the disclosure is essential for the purpose described above and we would ensure that:
- We share the minimum information required to achieve the purpose
- Access to the information is limited to healthcare professionals or those who owe an equivalent duty of confidentiality to a healthcare professional
- Those who would have access to the confidential information are involved in the proposed relevant processing and are fully aware of the purpose
- Appropriate technical and organisational (process-related) measures were in place to prevent unauthorised processing of the information.
Reports related to adverse reactions and or/exposures to medicines
This information will also be made available to the World Health Organisation’s Uppsala Monitoring Centre and pharmaceutical companies with identifiable details removed. We will also provide a copy of your report to your healthcare provider where you have requested this.
Retention and disposal
We only keep your personal information for as long as necessary to fulfill the purpose we collect it for, including reporting or legal requirements.
Disclosing your information
Safety data may be requested under the oversight of the UK competent authority (Medicines & Healthcare products Regulatory Agency), in this case we are legally obliged to provide the requested information.
Changes in our policy