Patient Engagement in Pharmacovigilance
Bridging the Gender Gap in Clinical Research: Addressing Inequalities to Improve Women’s Health Outcomes
2024 ABPI Code of Practice – What has changed?
CONTENTS
Letter from the President
By Chris Isaacs, PIPA President
Patient Engagement in Pharmacovigilance
By Dr Liz Clark and Fatima Auwal
Bridging the Gender Gap in Clinical Research: Addressing Inequalities to Improve Women’s Health Outcomes
By Claire Williams
2024 ABPI Code of Practice – What has changed?
By Jayne Packham
As always, feedback from the membership is welcomed and we encourage you to interact with us and the wider PIPA membership via our online platforms below:
Official PIPA Website: https://www.pipaonline.org/
LinkedIn: https://www.linkedin.com/company/pipa-pharmaceutical-information-andpharmacovigilance-association/
We hope to see you online at one of our events in the near future. If there is anything you would like to see PIPA get involved with or do, please do get in touch at pipa@pipaonline.org
We encourage more members to contribute to PIPELINE and make suggestions on topics for articles. Please contact us at journaleditor@pipaonline.org if you would like to contribute or make suggestions for the next edition.
LETTER FROM THE PRESIDENT
GREETINGS AND WELCOME
We live in a world where nothing stays still for very long. Change is inevitable and 2024 has seen its fair share of change. We’ve seen the UK turn from blue to red, the beginning of a Whitehouse reunion and most recently the completion of PIPA’s new-look Executive Committee. Those of you who attended the PIPA Conference or AGM will have been notified of the changes to both the President & Vice-President. Additionally, after 14 years of service, Sanjay Motivaras has decided to step down from the Committee with Stephanie Bettesworth taking up the role of Treasurer, effective immediately. We would like to thank Sanjay for his support and commitment to the association over the past 14 years.
Therefore, moving forwards, our Executive Committee looks like this:
CHANGES TO THE COMMITTEE
The continuity of any dynamic organisation lies in its ability to evolve. As committee members leave after completing their term with the association, we welcome new members and the wealth of experience and fresh perspectives they bring.
I am therefore delighted to introduce the following new committee members:
Aneka Shamla joins the PV Compliance and Conference Workstreams
Jo Elsdon joins the PV Compliance and Conference Workstreams
Tazneem Anwar joins the MI Compliance and Conference Workstreams
Helen Lowe joins the PV Compliance Workstream and Co-Chairs the Training Workstream
Ashish Vyas joins the Conference Workstream and Co-Chairs the Training Workstream
As always, PIPA is committed to its Vision to drive operational excellence and optimise the impact of pharmaceutical information and pharmacovigilance professionals.
In future editions of PIPELINE, we’ll be showcasing our new and
current committee members so you can get to know the faces behind PIPA. In addition, you can head over to our Committee page for more information on what each member contributes to the Committee and to you, the members.
PIPA CONFERENCE 2025
Another chance to meet the committee alongside industry experts is at the PIPA Conference and the conference planning team have been hard at work securing the venue with the aim to open bookings this side of Christmas. Be sure to ‘watch this space’ for details on booking and the early bird discount. For now, please save the date:
MI day: 10th September
PV day: 11th September
PIPELINE ARTICLES
As we usher in a new era for the PIPA association, it is with immense pride and optimism that I present the articles featured in this edition of PIPELINE:
• Dr. Liz Clarke discusses patient engagement and the potential impact on PV activities.
• Claire Williams addresses gender disparities within healthcare and what can be done in addition to current initiatives.
• A timely update on the ABPI Code by Jayne Packham
Finally, I would like to offer my sincere gratitude to all of you for being part of the PIPA journey this year and I am very motivated to continue our commitment to providing you with various learning, development and networking opportunities as we expect more change throughout 2025.
Chris Isaacs President
Sinem Castro Vice President
Stephanie Bettesworth Treasurer
Patient Engagement in Pharmacovigilance
Pharmacovigilance has often lagged behind other disciplines in implementing patient engagement. In general, Regulatory Authorities have been more proactive, and pharma could learn much from them. The impact of involving patients varies across the range of pharmacovigilance activities, but progress can be made by understanding best practice at a practical level and starting to implement them.
INTRODUCTION
Pharmacovigilance is an extensive scientific practice encompassing many steps and disciplines. These range from the collection, generation, and evaluation of safety data to behavioural science considerations that support adherence and the development of information that helps people administer and take medicines in the most safe and effective manner.
Whilst patients can be valuable contributors to all of these and in many different contexts, this article will focus on pharmacovigilance as practised by pharma.
The last article on patient engagement introduced the concept of patient engagement as involving patients and carers in activities whose outputs are intended for patients in the spirit of user design. Put another way, it’s collaboration with patients, for their benefit.
Whilst gaining momentum, implementation of this approach has varied, both between companies and the disciplines within them, pharmacovigilance frequently being one of the later adopters.
In contrast, regulatory authorities have been more proactive and have had a tangible impact. The first EU PRAC public hearing to consider risk minimisation measures with sodium valproate in 2017 resulted in additional restrictions on use in pregnancy, a warning signal and a patient alert card on the packaging.
The CIOMS Working Group XI report, Patient involvement in the development, regulation, and safe use of medicines, published in 2022, provides an extensive review of progress made to date and considers where and how patients can contribute. However, there is sparse documentation on how pharmaceutical companies implement patient engagement in pharmacovigilance.1
The MHRA launched their patient involvement strategy in 2021.2 As implementation proceeds, we see examples of how patients have been involved, such as within the steering group for the Innovative Licensing Access Pathway.3
The FDA have an active patient engagement program reflected in a clear call to action for patients on their website: “Learn About FDA Patient Engagement. Engage with the FDA! Our mission is to improve public health. We can’t do it without you: the patients, caregivers and advocates. We want to hear directly from you and learn about your experiences, preferences and needs as they relate to FDA-regulated medical products.”4
PATIENTS BRING A UNIQUE PERSPECTIVE
As reflected in the FDA’s call for patient input, patients and caregivers can provide the daily experience, perspective, and insights into living with a health condition and any challenges associated with taking medicine.
A simple place to start is to review information that is already available. Examples include patient publications, blogs, FDA ‘Patient Listening Session’ summaries and on social media.
SOCIAL LISTENING
Social listening involves collecting information posted by people with experience of health conditions from social media. This data has the benefit of being posted without the motivation to ‘say the right thing’, which so often confounds data collected through other sources. Raw and direct, it can provide insights into many aspects of living with a health condition. Of course, medicines may be mentioned, and side effects may be noted. Whilst, to date, social listening has not been considered a useful source for signal detection5, the data derived can reveal much about people’s lived experience with a condition. This can inform the planning of medicines information and risk mitigation strategies. Co-creation with patients is helpful in defining the hashtags and other search terms, particularly when unique to a particular patient community.
Digital data collection and research methodologies, such as social listening, can provide a good starting point. However, two-way conversation enables a deeper exploration of personal experience, how people use medicines, the impact of side effects, and ways of mitigating and managing them. This can be useful in problemsolving and can inform specific work, such as the co-design of plans for data collection, registries and studies, risk management planning, and patient education materials.
“There is just something to be said for face-to-face interaction; it is the most powerful, it is a force of nature, you must listen to me while I am speaking.”
Patient representative, van Hoof et al, 2022
One of the challenges with direct interaction is gaining a sufficiently broad perspective. While hearing a single individual’s experience can be insightful, it may not represent the wider population who are also using the medicine. In such cases, validating the perspectives and ideas of small groups with the broader population is essential.
When considering risk-benefit or patient trade-offs, “Patient Preference” methodology provides more robust insight than more informal methods.
PATIENT PREFERENCES
Patient preferences refer to data that reveal patients’ trade-offs in a real or hypothetical scenario. This can be useful when considering the acceptability of the risk of individual adverse events or the sideeffect burden as a whole. Both qualitative and quantitative methodologies have been validated for this purpose. The Innovative Medicines Initiative PREFER consortium has undertaken extensive research in this field in multiple therapy areas, which can be found in the further reading section. As with other research, involving patients as co-producers improves the quality and value of such work.
IN WHICH PV ACTIVITIES CAN PATIENT INVOLVEMENT BE MOST HELPFUL?
The value or impact of patient involvement will vary according to the activity, the patient engagement infrastructure and methodology used, and the condition for which the medicine is used.
Patient engagement is unlikely to have a significant impact in more technical, data-driven areas such as signal detection and causality assessment. However, when patients’ experience of living with a particular condition informs choices, content, and communication, the value of involving them increases.
Figure 1 arranges activities by the potential value of patient involvement together with consideration of the benefits and ideas of how this might be achieved.
PRACTICALITIES
Two significant challenges in involving patients in pharmacovigilance activities are the expertise or knowledge of the discipline required for meaningful participation and time constraints.
For example, the timelines will be short and pressured if you wish to involve patients in reviewing rapid safety communication. Even when the company has ongoing contact with patients familiar with product and drug safety practices, the logistic challenges of obtaining patient input remain considerable.
Less time-bound activities, such as risk management planning, materials production, study design, etc., allow more time to recruit contributors and provide them with the briefing required for them to contribute in a meaningful way. Maintaining ongoing relationships with such patient and carer contributors is good practice. If you do this, should a more urgent piece of work arise, you will have several individuals who will be knowledgeable and can advise reasonably rapidly. Larger projects, such as patient preference studies, PASS studies and patient support programmes generally require longerterm planning and multidisciplinary contribution in their design and delivery.
“Sometimes….we don’t hear the results of (their) hearings and meetings and so people afterward feel they weren’t heard; they never know exactly what was done with their opinions and with their work, so it is really important to have the full circle of patient involvement in the process, to give them the full feedback.”
Patient representative, van Hoof et al, 2022
In addition to collaborating with individual patients, consider collaborating with one or more patient organisations. As with individual patient relationships, this should also be an ongoing relationship. Patient organisations can provide a more general
Figure 1: Potential Impact of Patient Involvement in Pharmacovigilance
perspective than individual patients and collaborate directly on projects such as social listening, registries, patient preference, and PASS/PAES studies.
As patients become more involved in pharmacovigilance activity, refining and improving practice becomes possible. A recent
stakeholder analysis by Monica van Hoof and collaborators collected data from patient representatives, pharma and regulators and identified ‘best practice’ themes, illustrating these with specific activity types, which further illustrate how practice is evolving in this field.6
Develop trust and balance
Complete the circle of feedback
Engage from the start
Establish common goals
Educate and empower Collaborate as same level partners
PRACTICAL IDEAS TO CONSIDER
As with many endeavours, the journey to a culture of patient involvement begins with a single step.
• If your company has a patient engagement group, contact them to learn what know-how is already available and discuss possibilities for patient engagement in your work.
• Consider inviting expert patients to speak to your team about their experience. In return, be ready and willing to explain pharmacovigilance to them.
• Do a literature search for patient perspective/insights in the therapy areas in which you work.
• Consider how you might involve expert patients in reviewing and ideally, co-creating lay summaries of RMPs and other materials designed for patients.
FOOTNOTE:
A major aspect not covered in this article concerns improving safety data collection. There is significant potential for collaboration between regulators, pharmaceutical companies, and the patient community to increase awareness of the value of reporting adverse events and make it easier for people to do so.
Figure 2: Best Practices in Pharmacovigilance – adapted from van Hoof et al., 2022
SOCIAL LISTENING
Whilst focused on the use of social listening in Health Technology Assessment, the following papers are equally applicable to provide information on patient experience in other fields. The second paper contains principles for social media research:
Holtorf, Anke-Peggy, Andriy Danyliv, Li-Ying Huang, Yvette Venable, Alissa Hanna, Annekatrin Krause, Miranda Pierre, et al. ‘Using Social Media Research in Health Technology Assessment: Stakeholder Perspectives and Scoping Review’. International Journal of Technology Assessment in Health Care 39, no. 1 (January 2023): e63. https://doi. org/10.1017/S0266462323002593
Holtorf, Anke-Peggy, Andriy Danyliv, Annekatrin Krause, Alissa Hanna, Yvette Venable, T. Joseph Mattingly Ii, Li-Ying Huang, Miranda Pierre, Aline Silveira Silva, and Donna Walsh. ‘Ethical and Legal Considerations in Social Media Research for Health Technology Assessment: Conclusions from a Scoping Review’. International Journal of Technology Assessment in Health Care 39, no. 1 (January 2023): e62. https://doi.org/10.1017/S0266462323000399
PATIENT PREFERENCES
Innovative Medicines Initiative PREFER: https://www. imi-prefer.eu [Accessed 17 OCT 2024]
The PREFER Consortium, ‘PREFER RecommendationsWhy, When and How to Assess and Use Patient Preferences in Medical Product Decision-Making’, Version 4, 19 April 2022. https://doi.org/10.5281/zenodo.6592304
[Accessed 17 OCT 2024]
For further information, please contact Liz Clark at Liz@Kissanes.co.uk
REFERENCES
1. Council for International Organizations of Medical Sciences. Patient involvement in the development, regulation and safe use of medicines. https://cioms.ch/publications/ product/patient-involvement/ https://doi.org/10.56759/iiew8982
2. Medicines & Healthcare products Regulatory Agency. (2021). Patient Involvement Strategy 2021-2025. [online] Available at: https://assets.publishing.service.gov. uk/media/6405c608e90e0740dafbbc1d/Patient_involvement_strategy.pdf [Accessed 17th October 2024].
3. Barker-Hurden, C. (2023) ‘Medicines & Healthcare products Regulatory Agency MedRegs Blog’, [Online]. Available at: https://medregs.blog.gov.uk/2023/03/13/ reflections-on-the-shared-commitment-to-public-involvement/ [Accessed: 17 October 2024].
4. https://www.fda.gov/patients [Accessed 17 OCT 2024]
5. Van Stekelenborg J, Ellenius J, Maskell S, Bergvall T, Caster O, Dasgupta N, Dietrich J, et al. ‘Recommendations for the Use of Social Media in Pha rmacovigilance: Lessons from IMI WEB-RADR’. Drug Safety 42, no. 12 (1 December 2019): 1393–1407. https://doi.org/10.1007/s40264-019-00858-7
6. Van Hoof, M., Chinchilla, K., Härmark, L., Matos, C., Inácio, P., & Van Hunsel, F. (2022) Factors Contributing to Best Practices for Patient Involvement in Pharmacovigilance in Europe: A Stakeholder Analysis. Drug Safety, 45(10), 1083–1098. https://doi. org/10.1007/s40264-022-01222-y
Visiting Lecturer and Patient Engagement Theme Lead, Centre for Pharmaceutical Medicine Research,
student, Centre for Pharmaceutical Medicine Research, King’s College, London.
Dr Liz Clark
King’s College, London.
Fatima Auwal PhD
BRIDGING THE GENDER GAP IN CLINICAL RESEARCH:
ADDRESSING INEQUALITIES TO IMPROVE WOMEN’S HEALTH OUTCOMES WHAT CONTRIBUTES TO DIFFERENT HEALTH OUTCOMES IN WOMEN VS. MEN?
Factors that contribute to different health outcomes in women are widespread, ranging from how the social norms, expectations and responsibilities placed on women can impact their access to healthcare services and research settings, through to molecular and cellular differences between men and women [1]. Physiological variations may translate into differences in pharmacokinetics and/or pharmacodynamics for specific drugs, meaning that medications can work or be processed differently in people of different sexes [2].
Given my background in pharmacovigilance, I’m acutely aware that too many medications have been developed and approved which have later proven to be sub-optimal or even unsafe for women. For example, the medication Dofetilide was approved in 1999 to help control irregular or fast heart rhythms (atrial fibrillation). Despite this, it was only in 2018 that a study found that the recommended twice daily dose was too high in over half of female participants, as they developed other abnormal heart rhythms which could carry a risk of cardiac arrest [3]. In the original phase III DIAMOND study, there were only 61 women compared to 188 men in the treatment arm, with females constituting less than a quarter of all trial participants [4]. Sadly, this gender divide in clinical trials is often seen. Only in the last decade has this been highlighted as a cause of significant concern.
THE SEX AND GENDER GAP IN SCIENTIFIC RESEARCH
An unequal gender divide isn’t just present in late-stage human trials, but also in early-stage cell and animal testing. It was recently found that fewer than half of in vitro studies report the sex of their cells, and where they do, they are more likely to use cells which are male [5]. In another study across ten fields of biology, it was found that 80% of the animals used in early-stage research were male [6]. Given these findings, it is perhaps unsurprising that women are 5075% more likely to experience adverse drug reactions than men [7].
One reason why this gender imbalance has been historically overlooked is because of the so-called ‘bikini medicine’ approach, a worrying misconception that women’s health only differs from men’s in the parts of the body that a bikini would cover. Sadly, this perception is still evident in scientific research today. Analysing the health content of around 1,500 articles from major medical journals, a study found that the proportion of women’s health content focused on reproductive health had increased between 2010-2020, whereas areas such as cardiovascular disease, infectious diseases, and musculoskeletal disorders – which pose a greater burden to women worldwide – were under-represented [8,9].
This dominant focus on reproductive health, combined with overwhelmingly male-centric preclinical and clinical datasets, has contributed to worse health outcomes in women across a range of areas. For example, women are more likely to suffer with chronic pain and experience a higher chance of diagnosis later than men across hundreds of diseases, including some types of cancer [10,11].
WHY DOES THIS GAP EXIST?
The current underrepresentation of women in research stems from several historical failings and has been perpetuated by societal factors. In 1977, due to the thalidomide tragedy and concerns about potential risks to foetal health, the Food and Drug Administration (FDA) recommended excluding women of
childbearing potential, including those using contraception or with vasectomised partners, from early-stage drug trials.
While this blanket FDA exclusion rule was lifted almost three decades ago, low participation amongst women persists for several reasons. One significant concern is the potential ethical, financial and legal risks that sponsors may face if a female participant becomes pregnant during a trial. This concern stems from the need to ensure the safety of both the mother and foetus, which adds complexity to study protocols and increases liability for sponsors. However, rather than protecting women, evidence has shown their exclusion from trials has led to an unrepresentative assessment of drug efficacy and side effects, potentially leaving them at risk of serious harm [12].
The differences between the male and female responses to medicines are not simply related to average body size, but fundamental metabolic and hormonal differences. For example, female hormones allow women to convert food into fat more easily, causing increased deposition of fat, which has an impact on drug metabolism. [12]
Moreover, women may experience a greater risk of adverse reactions to medications and interventions compared to men, which may also lead to added burdens such as the disruption of daily activities, decreased quality of life, and increased financial costs [7,12]. These adverse reactions may deter some women from participating in clinical trials.
Many studies lack sex-specific analysis, despite clear evidence that men and women respond differently to treatments and disease progression. Excluding sex analysis from clinical trials limits the generalisability of the research findings, as biological factors can have a significant impact on disease manifestation, pathophysiology, and response to treatment. It’s striking to note that only an estimated 5-14% of studies examine outcomes by sex [13] highlighting how critical it is to address this significant gap in the data.
It appears there are both methodological and political barriers to advancing the knowledge of sex differences in clinical trials, with this additional complexity and cost unfortunately leading to sex specific analysis being underperformed.
Another important factor leading to underrepresentation is that women face practical barriers to taking part in clinical trials because they are often the primary caregivers, which leaves them with limited time and flexibility to take part in clinical research.
Furthermore, study design can be complicated due to age-related changes, such as the menopause which may introduce additional variables and considerations that need to be accounted for in the design and methodology of the trial.
Engaging with women directly and effectively to encourage participation in clinical trials remains a challenge, and while many women health experts openly acknowledge these barriers, there remains a surprising lack of proposed solutions.
WHAT IS CURRENTLY BEING DONE TO COMBAT THIS ISSUE?
It is essential that scientific research, from a cellular level, through animal testing and into clinical trials, particularly early phase trials, include more female representation to ensure better health outcomes and safety of healthcare interventions for women. This is not only for ethical and moral reasons, but to ensure more rigour and richness in the pursuit of understanding human biology, which could pave the way for future breakthroughs.
Gender equality in scientific research could bring with it significant economic impact at the individual and national level. According to recent projections, tackling the 25% disparity in the time spent by women in “poor health” compared to men could lead to an annual economic boost of at least $1 trillion globally by 2040 [14].
Encouragingly, steps are being developed to try to address gender inequalities in clinical trials. For example, the UK Health Research Authority (HRA) and Medicines and Healthcare products Regulatory
Agency (MHRA) have an initiative aimed at increasing diversity in research participation. This regulatory workstream is focused on developing guidance that encourages researchers to consider representation of underserved populations, including women, at the application stage.
However, while this is an important step, guidelines alone are not enough. There needs to be more innovation in trial design, utilising technological advancements and tapping into real world data sources to support a decentralised approach, to help encourage more female recruitment and alleviate the inequality burden further.
WHAT STEPS CAN WE TAKE TO ADDRESS THIS ISSUE?
As researchers, one of our core priorities needs to be ensuring inclusivity and diversity in clinical trials, including women and those hard-to-reach populations. A comprehensive strategy that focuses on collaboration and innovation is essential to tackle this issue. Having strong partnerships across different sectors, including healthcare providers, industry stakeholders, regulators and community advocates is critical to achieving gender equality Enhancing the representation of women in clinical trials calls for trial design to be flexible, convenient, and decentralised in design, to minimise barriers whilst leveraging innovative technology and realworld data.
A data-driven approach is essential for uncovering and addressing healthcare disparities. Analysing and re-assessing historical data with a focus on gender can highlight key gaps in women’s health outcomes, enabling targeted intervention strategies.
REFERENCES:
It’s important we establish trust and transparency through open communication and sharing of study results with participants to create a sense of value and encourage ongoing engagement. Advocacy and education are also crucial in raising awareness about these issues, empowering women to take charge of their involvement in research, and actively contribute to shaping inclusive and equitable scientific progress.
Instead of waiting for regulatory requirements to drive change, it is our ambition to make it possible for women to take an active step in increasing their inclusion in scientific research.
1. Mauvais-Jarvis F, et al. Sex and gender: modifiers of health, disease, and medicine [published correction appears in Lancet. 2020 Sep 5;396(10252):668]. Lancet. 2020;396(10250):565-582.
2. Brabete AC, et al. A Sex- and Gender-Based Analysis of Adverse Drug Reactions: A Scoping Review of Pharmacovigilance Databases. Pharmaceuticals (Basel). 2022 Feb 28;15(3):298.
3. Pokorney SD, et al. Dofetilide dose reductions and discontinuations in women compared with men. Heart Rhythm. 2018 Apr 1;15(4):478–84.
4. Pedersen OD, et al. Efficacy of dofetilide in the treatment of atrial fibrillation-flutter in patients with reduced left ventricular function: a Danish investigations of arrhythmia and mortality on dofetilide (diamond) substudy. Circulation. 2001 Jul 17;104(3):292-6.
5. Kim JY, et al. Sex omission and male bias are still widespread in cell experiments. Am J Physiol Cell Physiol. 2021 May 1;320(5):C742-C749.
6. Beery AK, et al. Sex bias in neuroscience and biomedical research. Neurosci Biobehav Rev. 2011 Jan;35(3):565-72.
7. Rademaker M. Do women have more adverse drug reactions? Am J Clin Dermatol. 2001;2(6):349-51.
8. Hallam L, et al. Does Journal content in the field of women’s health represent women’s burden of disease? A review of publications in 2010 and 2020. J. Women’s Health. 2022 May 1;31(5):611–9.
9. Global Burden of Disease Collaborative Network. Global Burden of Disease Study 2019. Last accessed February 2024: VizHub - GBD Compare (healthdata.org)
10. Samulowitz A, et al. “Brave Men” and “Emotional Women”: A Theory-Guided Literature Review on Gender Bias in Health Care and Gendered Norms towards Patients with Chronic Pain. Pain Res Manag 2018 Feb 25;2018:6358624.
11. Westergaard D, et al. Population-wide analysis of differences in disease progression patterns in men and women. Nat Commun. 2019 Feb 8;10(1):666.
12. Brazil, Why we need to talk about sex in clinical trials. https://pharmaceutical-journal.com/article/feature/why-we-need-to-talk-about-sex-and-clinical-trials. 2020 May
13. Under-representation of women in research: a status quo that is a scandal: BMJ 2023;382:p2091 http://dx.doi.org/10.1136/bmj.p2091 Published: 14 September 2023
14. Ellingrud K et al., Closing the women’s health gap: A $1 trillion opportunity to improve lives and economies. McKinsey Health Institute. 2024 Jan 17. https://www.mckinsey.com/mhi/our-insights/ closing-the-womens-health-gap-a-1-trillion-dollar-opportunity-to-improve-lives-and-economies
Claire Williams Head of Pharmacovigilance and Regulatory Services NWEH
2024 ABPI CODE OF PRACTICE
– What has changed?
Jayne Packham, an ABPI Code of Practice expert, takes us through the key changes in the 2024 ABPI Code.
The 2024 ABPI Code of Practice has arrived and so it is out with the green and in with a soft peach.
IMPACT ON MEDICAL INFORMATION?
If you are doing an enquiry handling role in Medical Information, the good news is that it is business as usual. There are no changes that explicitly impact the role.
However there is one reference (clause 12) to the Windsor Framework. From 1st January 2025, marketing authorisations (MAs) that were issued by the European Commission (for products approved through the European Medicines Agency centralised procedure) will no longer be valid in Northern Ireland. Instead, the MHRA will issue UK-wide MAs for these products. The EU licence number that was assigned to Northern Ireland licenses will no longer apply.
From the 1st January 2025, Medical Information responses need to reflect the new UK-wide MAs. Plan ahead and start drafting and approving the new responses. If you currently use Datapharm’s emc Northern Ireland this will close at midday on 31st December 2024. Make sure there are no broken document links in your responses.
The PMCPA has issued a guidance document explaining the impact of the Windsor Framework on promotional materials.
CHANGES TO PRESCRIBING INFORMATION (PI) AND OBLIGATORY INFORMATION
The biggest changes relate to the provision of PI and adverse event reporting statements in promotional materials.
• Some promotional materials can take advantage of providing the PI via a QR (quick response) code.
• The PI must be immediately apparent on promotional materials (no turning pages or scrolling). If it is not, promotional material must include a clear and prominent statement as to where the PI can be found. This was already a requirement for information on the internet but has now been expanded to include all digital and print materials.
• The adverse event reporting statement should preferably be included as a prominent statement on the material itself, but can alternatively be included in the PI.
HIGH STANDARDS
Clause 5.2 has been strengthened to make it clear that everyone must maintain a high standard of ethical conduct. This applies to members of staff, those retained by way of contract and third parties. This includes contractors and any outsourcing partners. Ensure they are all trained on the ABPI Code.
MEETING SUPPORT
The PMCPA were concerned during company audits that there was not enough documentation when companies support healthcare professionals or other relevant decision makers to attend meetings or events. Financial transparency is key.
Support could include paying for a doctor’s registration fees, accommodation or travel to attend a conference. As a result, companies will now need to document their rationale to support the person and then put a written agreement in place making it clear what the company is paying for.
OTHER CHANGES
There are smaller changes throughout the Code. An increase to £15 + VAT for items for patient support. Clarification of how you can work with patient organisations. Certifying the collaborative working project initiation document. And ensuring companies add links to Disclosure UK so that people can easily find payments made to patient organisations and contracted services with the public.
The consultation on the Code proposal resulted in many new suggestions and these will be explored in another public consultation, probably in 2025.
WHAT WAS NOT CARRIED FORWARD?
There were proposals to change the names of signatories and give AQP (appropriately qualified person) signatories additional certification responsibilities and a requirement for signatory validation and re-validation. None of these were taken forward into the 2024 ABPI Code. Likewise subtle changes to the placement of black triangles in digital materials were not adopted.
FINDING OUT MORE
The PMCPA have materials on their website explaining the key changes. If you need detailed information or help rolling out the changes, do get in touch.
jayne@jaynepackham.co.uk
Jayne Packham Managing Director Jayne Packham Consultancy Ltd
