Helping ensure patient health and safety

Our patient health and safety activities are focused on three key areas: patient safety and product quality, combating falsified medicines, and health education and prevention. We maintain an array of systems and processes, backed by cutting-edge technology, to continuously monitor and systematically review the data collected for products in our portfolio, both on the market and in development. It is also our responsibility to balance the risks and benefits of our treatments, clearly reflecting these in the product labeling, so that patients and physicians can make informed treatment decisions.

Maintaining patient safety and product quality

Patient safety and product quality are our top priorities. We maintain a robust quality system with harmonized processes and procedures, in compliance with external regulatory requirements and standards. We continually monitor and adhere to new regulations from health authorities and other regulators for both marketed products and investigational molecules. We conduct thorough investigations when deviations, out-of-specification and/or failure of our manufacturing processes to meet our quality standards, current Good Manufacturing Practices (cGMP) and other applicable regulations occur.

For 100% of manufacturing, supply and distribution of our pharmaceutical products, we hold the relevant manufacturing licenses and GMP/GxP certificates issued by the appropriate external health authorities – for example, the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), the World Health Organization (WHO) and Swissmedic – that confirm after inspection that our duties, including our quality management systems, comply with their strict regulatory requirements. For the manufacture of medical devices, we hold the relevant certifications from the International Organization for Standardization (ISO) and other notified bodies. Please see the Novartis Quality Management System section of our website.

To help ensure compliance with external regulatory quality and safety standards, and support the continuous improvement of our quality management system, Novartis has a robust and independent audit program that covers the product lifecycle¹.

Travel restrictions introduced by the COVID-19 pandemic resulted in business disruptions across Novartis and our external partners globally. Auditor travel was temporarily paused, which impacted our ability to complete all the audits listed in our 2020 Unified Quality Audit Program (UQAP) plan.

The global audit team worked with all business partners to reprioritize good practice (GxP) audits planned in the UQAP to help ensure that as many high-risk audits as possible could be completed before the end of 2020. In parallel, the global audit team took several measures to conduct risk-based assessments either fully off site or through a combination of off-site assessment and short on-site audit when travel was possible. We will apply these measures until travel restrictions are lifted in all geographies in scope of the Novartis audit universe, and also in cases where remote audits are a more viable option. For those audits that were postponed, appropriate risk mitigation actions have been implemented.

Health authority inspection programs were also impacted, with inspections being postponed or conducted remotely. Novartis was subject to 19 remote inspections, all of which had acceptable outcomes. Postponed inspections will be performed as soon as possible, based upon a risk-benefit evaluation by the competent health authority. While pursuing our transformation, we maintained a focus on quality. Of 126 inspections of our facilities by health authorities around the world, all but one were found to be acceptable (99.2%). The one inspection that may require further improvement was due to increased inspection focus on our clinical activities. The final classification of this inspection is still to be determined.

Novartis has a companywide process to assess quality defects and safety issues, and determine whether an action such as a recall is required. Any such incident is investigated and assessed by subject matter experts, quality management, medical safety experts and regulatory teams. Conclusions are provided to the appropriate health authorities with all relevant documentation, including a safety assessment, and market actions such as recalls are executed as agreed with these authorities. Novartis initiated 27 recalls in 2020. There were no global recalls.

We work with health authorities around the world to continuously review all chemical and biological human medicines for the possible presence of nitrosamines. The EMA, the FDA and other health authorities have provided guidance to the pharmaceutical industry to prevent unacceptable levels of nitrosamines in medicines. The EMA review is due to conclude in March 2021 for chemical human medicines and in July 2021 for biological human medicines.

We have a very robust quality and safety training process (initial and continuous training) for our associates and third parties, and we are regularly audited on our training procedures. All third parties providing services or products manufactured to GxP standards are required by regulation to have their own quality assurance department and a formal training process. Novartis routinely assesses the capability and effectiveness of third-party training programs during audits to confirm suitability for the provided service or product. Despite the challenges created by COVID-19, we have maintained our quality and safety training process.

¹ Third-Party audits pertaining to standards for ethics, business integrity and environmental sustainability are conducted by TPRM (see the section regarding managing risk in our supply chain)

Expanding pharmacovigilance efforts

We continue our efforts to boost pharmacovigilance capabilities and support patient safety worldwide. This entails activities to educate patients, providers and pharmacists; increase the use of digital technology; and strengthen reporting for adverse events. While clinical trials provide important information on a medicine’s safety, it is only after its use in greater numbers of patients in the real-world setting that some adverse events come to light. A robust, accurate and real-time adverse event reporting system is crucial for us to maintain the safety and well-being of our patients worldwide. We are further strengthening reporting through the development of advanced algorithms to screen and analyze multiple data sources for adverse events, including projects that employ robotic process automation, machine learning and natural language processing as a complement to traditional pharmacovigilance methods.

In addition to optimizing our global adverse event reporting system, countries conducted several patient safety initiatives in 2020.

In Austria, the Czech Republic and Ukraine, we organized workshops with healthcare professionals to raise awareness on pharmacovigilance and adverse event reporting, and to guide the development of risk management plans.

In Egypt, we supported efforts to bring attention to the importance of correct dispensing practices among pharmacists.

In Germany, we contributed to drug monitoring activities and logistical support for multiple sclerosis patients to assist with everyday challenges related to their therapy. We also helped breast cancer patients use virtual workshops and live chat to connect with specialist physicians in order to discuss how they respond to medication.

In Portugal, Novartis Patient Safety launched a series of web-based videos with content promoting the need for patients to read safety information in product leaflets and report adverse events.

In Sweden, we collaborated with universities to incorporate pharmacovigilance education into the curriculum of aspiring physicians.

Novartis Patient Safety teams worldwide are supporting the company’s COVID-19 response, with two task forces. The first task force evaluates all Novartis products from a benefit-risk perspective and helps ensure patients continue to receive essential medications. The second monitors COVID-19 impacts on Novartis pharmacovigilance and medical device vigilance systems, helping ensure a rapid response when needed.

With a growing number of medical devices in the Novartis portfolio, we have additionally built a robust vigilance system to monitor adverse events associated with medical devices worldwide. Novartis became the first company certified for compliance with the new European Medical Devices regulations, which will come into force in May 2021.

In 2020, Novartis Patient Safety also obtained an ISO 9001 certification for its pharmacovigilance governance, confirming that Novartis has the appropriate processes in place to oversee patient safety.

Combating falsified medicines

Combating falsified medicines (as defined by the World Health Organization) is part of our commitment to expand access to quality medicines worldwide. Pandemic-related lockdowns introduced challenges that pushed us to deploy new efforts to help keep patients safe. In 2020, we focused on strengthening the capacity of our team, developing and using new anti-counterfeiting technological capabilities, and deepening our collaboration with law enforcement authorities. Since 2017, our efforts have helped prevent falsified medicines from reaching and harming more than 1.4 million patients.

Governance

We strengthened our governance structure with the executive-level Trust & Reputation Committee now overseeing our work to combat falsified medicines. 

The Combating Falsified Medicines team contributed to a new online dashboard, developed by the Ethics, Risk & Compliance (ERC) and Novartis Business Assurance & Advisory (NBAA) functions. This dashboard went live in October and links the various company risks across the world, including criminal activities related to medicines (enforcement cases and products seized, for example). We added six full-time employees to the team covering governance, forensics and regional operations, thereby doubling the company’s workforce devoted to fighting falsified medicines.

Intelligence

We routinely monitor marketplaces, online pharmacies and social media platforms for evidence of falsified medicines. Our monitoring led to 68 online investigations and the removal of over 13 900 illegal product listings. Early in the pandemic, we doubled capacity in online monitoring and enforcement to mitigate the increased counterfeiting risks against medicines used to potentially treat COVID-19. We regularly briefed Interpol and Europol on new risks and supported their anti-counterfeiting efforts.

Further, we are leveraging data analytics and pharmacovigilance data of adverse events reported to Novartis to flag suspicious products for investigation.

Prevention

We take a holistic approach to preventing harm caused by falsified medicines using data analytics and the latest available technologies in spectrometry, anti-counterfeiting packaging features and mobile applications.

In cases where we identify falsified medicines, we are committed to complying with the WHO’s recommendation to voluntarily report all confirmed incidents within 10 working days. To this end, we updated our internal standard operating procedures regarding incident reporting, and we trained associates in the countries.

In light of COVID-19, we took additional steps to secure our products and supply chains. For hydroxychloroquine, a malaria treatment that was investigated as a potential treatment for COVID-19, we enhanced warehouse security, organized secure transit, GPS-tracked all shipments, sought best-in-class advice on supply chain security, and deployed 24/7 supply chain monitoring. We also provided our teams in high-risk countries with updated spectrometric data used for product authentication in the field. To secure the authenticity of the products, we extended security features on secondary packaging for product verification and anti-tampering.

In January 2020, Novartis began co-leading with Universidad Politécnica de Madrid an industrywide public-private partnership under the Innovative Medicines Initiative (IMI) umbrella to use blockchain technology to enhance pharmaceutical supply chain security. Known as PharmaLedger, the project aims to develop a scalable blockchain-based platform for securing supply chains, clinical trials and health data. Twenty-nine public and private partners are participating in this two-year project, including 13 global pharmaceutical companies.

We continue to support local health authorities through Authentifield by Novartis, a pilot program launched in 2019 to supply LMICs with affordable spectrometric sensor technology to detect falsified medicines. To date, 40 devices have been deployed in 14 countries, mainly across Africa but also in South Asia and Latin America.

In October, we also launched a pilot called MOVE, which enables our in-country sales and regulatory teams to use a mobile application to verify Novartis secondary packaging equipped with security features. We plan a global rollout in 2021 and are also exploring ways to empower healthcare professionals and patients with this technology.

Enforcement

While pandemic lockdowns strained enforcement capabilities in 2020, we maintained operational excellence through close collaboration with international agencies, including Europol, Interpol, the World Customs Organization and the Pharmaceutical Security Institute. We investigated 247 incidents of suspected falsified medicines, which led to 60 successful enforcement actions and the seizure of 1.7 million medicines (unit dosage forms) by law enforcement and health authorities.

In Colombia, our work with law enforcement authorities led to the dismantlement of a criminal network and the seizure of 7.8 million units of falsified medicines impacting several companies – the largest seizure in the history of Colombia. In China, an enforcement action from 2018 led to the conviction and sentencing of several criminals in 2020 for their involvement in the manufacturing of falsified medicines.

Stakeholder engagement

We made significant progress on policy advocacy projects, notably with the United Nations (UN) Conference on Trade and Development addressing the impact of illicit trade on the UN Sustainable Development Goals. We contributed to an Organization for Economic Co-operation and Development report called “Trade in Counterfeit Pharmaceutical Products,” joining the expert panel and sharing an industry perspective during the virtual launch event.

Through the International Pharmaceutical Federation, we conducted virtual events for more than 2 500 pharmacists that provided education about falsified medicines in the context of COVID-19. This led to a new collaboration with the Commonwealth Pharmacist Association focusing on online modules and webinars, and supported efforts to strengthen falsified medicines policy.

We also intensified public awareness efforts through participation in global campaigns such as Fight the Fakes. Additionally, we supported the Unreal Campaign in developing training materials about pharmaceutical crime. We increased associate awareness of the topic through various webinars and stories published on internal Novartis channels.