Industry Code and Regulations

As well as ensuring compliance with the law, in the pharma/biotech world, there are strict industry codes and regulations in place which organisation must adhere to.

To bring a medicinal product or device to market there is more to be considered than the mammoth task of obtaining sufficient data to ensure it is efficacious, of good quality and safe in order to successfully obtain a marketing authorisation, or CE mark.

In addition to the legal parameters, there are strict Industry Codes of Practice (e.g. ABPI, EfPIA, other local Country Codes) which must be adhered to with regard to the claims which can be made, how scientific information is shared, the promotional materials and activities which can be undertaken, and to whom such data can be shared, to ensure the safety of patients remains paramount and confidence within the Industry is maintained.

So how do you navigate these Industry Codes:

Exchange of Scientific Information
Interactions with HCPs
Fair and Balanced Claims
Social Media Campaigns
Joint Working
Patient Support Programs
Sponsorships, Grants & Donations

Expert Guidance on Pharmaceutical Industry Codes of Practise and Regulations

Our team of global industry legal and compliance experts bring extensive in-depth, practical knowledge and regulatory expertise to guide you through the pharmaceutical industry codes of practise (e.g., ABPI and EFPIA) and the matrix of statutory and self-regulatory rules which apply to the marketing of medicines.

Industry Codes of Practice and Guidelines (e.g EFPIA & ABPI) and Other Local Country Codes Across the Globe.

Our in-depth knowledge and first-hand practical experience from years working in the pharmaceutical industry mean we bring real expertise to assist you on industry code of practice issues.

Our consultants have many years’ experience working in legal and compliance functions in the pharmaceutical industry and our expertise spans a wide range of pharmaceutical organisations and therapy areas in multiple jurisdictions across the globe, so we have in-depth knowledge and first-hand practical experience of working with and supporting pharmaceutical organisations on pharmaceutical industry code of practise issues.

We understand the complex statutory and self-regulatory rules and standards governing the promotion of prescription only medicines and other interactions and activities undertaken by companies in the pharmaceutical industry and we know how to expertly navigate these rules and regulations to provide creative solutions and ensure compliance with all your activities and interactions, including advising on more complex and innovative projects as well as compliance management work.

Interactions with Healthcare Professionals (HCPs), Healthcare Organisations (HCOs) and Patient Organisations (POrgs)

LS Law consultants can support you with specialist expertise to ensure your interactions with healthcare professionals, healthcare organisations, patient organisations and patients are appropriate, compliant and properly documented.

Our expertise means we can provide comprehensive support on the wide range of activities, relationships and interactions pharmaceutical companies have with healthcare professionals, healthcare organisations, patient organisations patients and the public. We understand how to ensure relationships are appropriate and how to structure them to ensure code of practise compliance and we can work with you to develop the right documentation to properly govern these relationships and protect your organisation.

Joint Working and Collaboration with Healthcare Providers (e.g. NHS)

We have in-depth expertise to support and advise on collaboration and joint working initiatives with healthcare providers, including advising on structuring collaborative and joint working projects compliantly, measuring outcomes and preparing the necessary contractual documentation.

We can work with you to develop compliant and creative solutions for these specific initiatives for enhancing patient care and benefitting patients, including advising on the detailed rules and regulations governing collaboration and joint working projects and preparing documentation to properly govern your relationships with parties involved in the collaboration or joint working project.

Commercial Deals

We can provide tailored advice on commercial deals such as simple discount schemes, outcome or risk sharing agreements to ensure they are appropriate and properly documented.

Our expertise allows us to support companies on a wide range of commercial deals common in the pharmaceutical industry, from simple discount schemes to patient access schemes and outcome and risk sharing arrangements. We can assist you in structuring these deals, ensuring they do not amount to inducements to prescribe and make sure the complexity of the arrangements is documented appropriately.

Patient Support Programmes

Our extensive expertise covers the breadth of code of practise, legal and regulatory issues you may need to consider and address when initiating and conducting a patient support programme from design, through to initiation, ongoing management and closure.

We have in-depth practical experience supporting these initiatives and can help you to ensure your patient support programme is structured appropriately, assist in preparing contractual documentation, advise on data issues and ensure that other ethical, legal and regulatory obligations affecting your patient support programme, such as pharmacovigilance requirements are met.

Recording and Publishing Transfers of Value to HCPs, P Orgs, HCOs. Disclosure of Transfers of Value

Benefit from our experience in advising on code of practice disclosure requirements, ensuring transparency in relationships and transfers of value to healthcare professionals, healthcare organisations, patient organisations and the public.

We have significant experience advising on code of practise disclosure requirements in relation to transfers of value to healthcare professionals, healthcare organisations, patient organisations and the public and can advise on issues from the types of funding/support and details requiring disclosure to permissions and data privacy aspects as well as the detailed processes to enable disclosure and record keeping.

Development of Promotional and Non-promotional Materials

From launch to late life cycle, we can assist in ensuring the development of compliant, robust, and effective marketing campaigns and materials, addressing the complex rules of industry codes of practise.

A very wide range of marketing materials and activities undertaken by pharmaceutical companies (promotional and non-promotional) are subject to complex rules and requirements of industry codes of practice. We have extensive experience navigating the myriad of these rules from launch to late lifecycle and can work with you on routine as well as more complex projects to develop compliant, robust and effective marketing materials.

Digital Marketing and Social Media Campaigns

We can help you to navigate the unique regulatory challenges of pharmaceutical social media campaigns and digital marketing activities with our in-depth, practical expertise gained from many years of hands-on legal and compliance experience in pharmaceutical companies.

Social media campaigns and digital marketing activities in the pharmaceutical industry raise unique regulatory challenges. We have in-depth knowledge advising on all types of innovative digital marketing activity and can bring real expertise to assist with global and targeted social media campaigns.

Supporting the Organisation of Local and Global Congresses and Events

Pre-licence Activities

Our consultants have been involved in the launch of many different medicines in a wide range of therapy areas and have significant experience working with the codes of practise so can provide expert guidance and advice on pre-licence activities to guide you through this potentially difficult area.

We can provide expert legal and compliance support to assist you in preparing for the launch of a new medicine, including advice on the legitimate business activities which can be undertaken in the pre-licence period, such as advisory boards, advance budgetary notices, provision of disease information, responses to enquiries and scientific exchange.

Congress and Event Organisation

Our experts can guide you through the compliance and regulatory complexities of organising local and global congresses and events, turning your vision into reality.

Congresses and other meetings and events often raise compliance and regulatory complexities, which we can help you to navigate so you can bring your congress vision to
fruition.

LS Law provides specialist legal and compliance support for the life sciences industries.

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