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Becton Dickinson

BD

BD is a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.

Lobbying Activity

Meeting with Anne Simon (Head of Unit Health Emergency Preparedness and Response Authority)

13 Nov 2025 · Challenges encountered by BD in the production line of syringes in Europe

Meeting with Chiara Galiffa (Cabinet of Commissioner Maroš Šefčovič)

6 Oct 2025 · EU – US relations

Response to EU cardiovascular health plan

12 Sept 2025

Vascular vs Coronary There is strong advocacy campaign around the CVD plan for coronary diseases, while vascular diseasesparticularly peripheral arterial disease (PAD)that are emerging as a silent driver of disability and death , often receives less or none attention . PAD not only increases the risk of heart attack and stroke but also leads to devastating complications such as lower-limb amputations, which carry high mortality rates and a major impact on quality of life. There is an estimated 3.18 million people in the EU with lower limb amputations and about 295 000 amputations are performed annually (CORDIS -EU Research). Amputations are a stark example of the human and economic cost of under-recognized vascular disease, yet PAD is frequently underdiagnosed and undertreated compared with other cardiovascular conditions. To strengthen the upcoming EU cardiovascular disease plan, it is essential to reinforce the visibility of vascular diseases, placing PAD alongside coronary and cerebrovascular disease as a major public health priority. This requires the introduction of systematic PAD screening programs, particularly for high-risk populations such as people with diabetes, smokers, and older adults, ensuring early detection and timely intervention to prevent complications. Early detection and timely treatment can prevent amputations, reduce health system costs, and save lives. Health checks The use of minimally invasive capillary blood collection systems for lipid and HbA1c screening offers significant advantages in expanding access, reducing costs, and improving patient adherence. Because these systems rely on a simple fingerstick rather than venipuncture, they can be performed quickly and safely by a wide range of healthcare professionalsincluding nurses, primary care staff, and even retail pharmacistswithout the need for specialized phlebotomy training. This flexibility is especially valuable in light of the current shortages of phlebotomists and other highly trained personnel. By lowering infrastructure and labor costs, and by bringing testing closer to where patients live and seek routine care, minimally invasive capillary testing facilitates earlier detection, improves follow-up rates, and makes large-scale screening programs for cardiovascular risk and diabetes more sustainable. Future health checks stand to benefit enormously from innovations in non-invasive blood pressure and advanced hemodynamic monitoring systems that are increasingly compact, wearable, and even telephone-sized. These technologies have the potential to move cardiovascular assessment out of specialized clinics and into everyday settings, enabling continuous, real-time monitoring without the need for bulky equipment or invasive procedures. By capturing subtle changes in hemodynamics, portable devices could help detect early warning signs of coronary problems before they manifest as acute events. This not only supports timely intervention and personalized prevention strategies but also reduces the burden on healthcare systems by shifting monitoring into primary care, pharmacies. Urinary Incontinence Urinary incontinence is a common yet under-recognized complication among female patients with chronic heart failure and in those recovering from stroke, with serious implications for both clinical outcomes and quality of life. Beyond contributing to higher hospitalization rates and treatment non-adherence, incontinence deeply impacts dignity, independence, and psychosocial well-being. For these reasons, it is vital that European Union CVD action plans integrate incontinence management as a core component of gender-sensitive care. The adoption of external urinary collection systems plays a critical role in reducing infection risk, supporting equitable care, and safeguarding patient dignity.
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Meeting with Adam Romanowski (Cabinet of Commissioner Maroš Šefčovič), Bernd Biervert (Cabinet of Commissioner Maroš Šefčovič)

27 Aug 2025 · EU-US trade and investment relations in the medical technology sector

Response to Critical Medicines Act

5 Feb 2025

The visibility of the supply chain, stocks and demand, in the down stream is critical to anticipate and improve management of medication shortages. This visibility of the supply chain in conjunction with Data analytics and AI systems, have multiple benefits: 1. Improved Forecasting and Inventory Management: By increasing transparency in the supply chain, Member States can better predict and respond to potential shortages. 2. Enhanced Collaboration: Clear visibility allows for more effective coordination between all parties involved. Member States can enhance collaboration among hospitals, wholesalers, distributors and retail pharmacists, sharing information and resources to address supply gaps swiftly and efficiently. 3. Informed Decision-Making: Real-time data on medication availability and usage patterns empowers Member States and stakeholders to make informed decisions, like estimate the right contingency stocks at any time and reallocate them to Member States in need in case of supply disruption or shortage, based on the solidarity principle , reducing the risk of overstocking and understocking. Nevertheless, EU Member States do not have visibility of medication stocks in the downstream supply chain. There are some best cases, for example in Greece and Spain , around medicines stocks visibility in the retail pharmacies, but not a single country has visibility of stocks in the whole supply chain. Hospitals are vital infrastructures for responding to cross-border health threats, as was the case with COVID-19, as they admit and treat patients during crises. The COVID-19 pandemic management in intensive care units has dramatically increased the prescriptions of sedatives (propofol, midazolam) and neuromuscular blockers (NMB) at the international level, creating shortages in all countries. Hospitals were not prepared to provide visibility of stocks in real-time and electronically to crisis management bodies at the Member State level. In many countries, hospital Pharmacists performed manual counts of sedative stocks in the intensive care units and provided back the information in the form of text messages, excel files, etc. The role of digitalization and automation of medication management in hospitals is critical to allow real-time and electronic visibility of the medication stocks in the whole hospital, pharmacy and wards. Inventory robots in hospital pharmacies and automated dispensing cabinets in the wards, all connected to IT inventory management systems, enable real-time , accurate and electronic visibility of medication stocks in the hospitals, facilitating the connection with National and European supply chain systems. Nevertheless, unfortunately the penetration of digitalization of medication management in EU is not acceptable. The single reference is the study conducted by the ECAMET Alliance (www.ecamet.eu) in 13 European countries. The study shows that the penetration of pharmacy information systems, inventory robots and automated dispensing systems in wards in hospitals is very low. Call for action: 1. Medicines Act should include the requirement of developing IT systems at Member State level, connected with HERA, to ensure visibility of the stocks in the downstream of the supply chain (retail pharmacists, hospitals, distributors and wholesalers). This visibility of the supply chain in conjunction with demand projections , Data analytics and AI systems, would help Member States and HERA to predict and respond to potential shortages, estimate the right contingency stocks at any time and reallocate them to Member States in need in case of supply disruption or shortage, based on the solidarity principle. 2. As a result of the low level of digitalization and automation of medication management process in hospitals in Europe , the successful deployment of the above IT systems would require investments. This important topic should be addressed in the Medicines Act.
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Meeting with Adam Romanowski (Cabinet of Commissioner Maroš Šefčovič), Bernd Biervert (Cabinet of Commissioner Maroš Šefčovič), Chiara Galiffa (Cabinet of Commissioner Maroš Šefčovič), Renata Goldirova (Cabinet of Commissioner Maroš Šefčovič) and

29 Jan 2025 · EU-US trade

Meeting with Sabine Weyand (Director-General Trade) and

29 Jan 2025 · Transatlantic trade relations in the second Trump administration.

Meeting with Ioan-Dragos Tudorache (Cabinet of Executive Vice-President Stéphane Séjourné) and JPMorgan Chase & Co. and

27 Jan 2025 · Policies to improve EU’s business environment and competitiveness, business concerns related to regulatory burdens, and key sectoral challenges.

Response to Cyber Resilience Act

13 May 2022

BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. BD helps customers enhance outcomes, lower costs, increase efficiencies, improve safety, and expand access to healthcare. At BD we acknowledge that cybersecurity is one of the critical issues impacting resilience throughout the critical sectors within the EU, including healthcare and we hold a similar position in the B2C market of digital products and services. As such, we understand the Commission’s concerns, and that new legislation is required in addition to the current European regulatory framework of cybersecurity regulations, e.g., the NIS (2) Directive and the Cybersecurity Act. With globally fragmented sectoral and non-sectoral cybersecurity regulations, BD advocates harmonization and uniformity of regulations, and we believe that the success of the Cyber Resilience Act will depend on such harmonization. As such, the Commission should consider that the medical device industry is one of the most highly regulated industries in the EU, and that product lifecycle cybersecurity requirements are already included in the MDR and IVDR regulations. The currently existing cybersecurity requirements have been further detailed by the Medical Device Coordination Group (MDCG) in their 2019-16 guidance and are part of Notified Body Assessment. We therefore urge the Commission that any new horizontal cybersecurity legislation for products and services remove medical devices from the scope of the legislation as these requirements are likely to be broad, not readily applicable to meet the needs of the medical device industry, or duplicative of current cybersecurity requirements under MDR and IVDR. Alternatively, the legislations could be written so that it aligns with the current cybersecurity requirements under MDR and IVDR. This will ensure uniformity and clarity across the Union and decrease duplicative regulation and undue burden for the medical device industry. The Commission should also consider that any additional Notified Body Assessment on top of the current Notified Body obligations under MDR/IVDR would put an unnecessary financial burden on medical device manufacturers such as BD, hampering technological improvements and eventually efficient and effective healthcare. Hence, assessments should remain under the current MDR/IVDR regulations or self-assessment to the new horizontal legislation should be considered for our sector.
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Response to Recommendation for strengthened actions against antimicrobial resistance

21 Mar 2022

Infection Prevention and Control: Lack of Harmonized Guidelines 1. Create a European Framework on HAI prevention and control. Within a broader European legislative framework on infection prevention and control, it is necessary to build consensus around evidence-based guidelines such as the one from WHO and define clear protocols to prevent SSI. 2. Harmonising evidence-based guidelines, protocols and quality indicators in Member States (MS) . The European Commission should facilitate the creation of an Expert Forum with ECDC to develop and adopt evidence-based guidelines (such as the WHO Guidelines) and to support their implementation across Europe. It is necessary to include quality indicators on HAI reduction in the European Semester as a policy tool to motivate national progress on HAI prevention and control; to design future EU funding opportunities and conditionalities to boost national policy and implementation capacity. Infection Control and Prevention: In 2011, ECDC conducted a systematic review of the effectiveness of infection control measures to prevent the spread of CRE, with an update in 2014 and 2017. Recommendation: 1.-ECDC to revise existing guidance from 2017 on infection prevention and control measures and tools for the prevention of entry of CRE into healthcare settings, including the use of molecular technology where applicable 2.-MS to implement national programs to implement active surveillance through rectal screening for CRE carriage on hospital admission to specific wards/units, and during outbreaks, following revised guidance by ECDC. Surveillance Recommendation: MS to implement national surveillance systems, to be connected at EU level. As noted above, these should include healthcare-associated infections that are well characterized and understood to be preventable: CLABSI, CAUTI, CRE, MRSA, SSI. Diagnostic and Antibiotic Stewardship Recommendations: 1. Local antimicrobial stewardship teams. 2. Tracking use of antimicrobials within healthcare systems: a. Electronic prescription systems (CPOE) b. Automated Dispensing Cabinets (ADCs). Transaction logs can be used to secure third line or restricted antibiotics that require microbiology approval before prescribing . The ADCs can flag the requirements and indicate such approval if used in profile mode and interoperatively with the electronic prescription.system. Once in place access is granted. c. Electronic preparation systems d. Bar coded medication administration (BCMA) 3. Metrics related to successful antimicrobial stewardship programs. 4. Accurate and rapid diagnostic testing 5. Antimicrobials should be optimally used in patient care with improved use of diagnostics Diagnostic and Antibiotic Stewardship in long term care facilities (LTCFs) OECD recent report (attached) suggest that up to 75% of antibiotic prescriptions in LTCFs are inappropriate regarding prescription, duration and choice of therapy. Recommendations: Inclusion of specific plans in MS to reduce AMR in LTCFs Plans should include among others: 1.Adoption of medication traceability systems in LTCFs, including :Electronic health record (EHR) for patients,CPOE with clinical decision support (CDS) ,Automated Dispensing Cabinets (ADCs) (transaction logs can be used to secure third line or restricted antibiotics that require microbiology approval before prescribing) , medication dispensing through multidose systems (solid medications are machine-dispensed together into disposable sachets, individually labelled with barcodes, and BCMA to check the patient identification and the medication. 2. Where possible, no antibiotic should be prescribed without the result of one diagnostic test (laboratory or point of care test). The COVID-19 pandemic has shown the benefits of rapid point of care tests in healthcare settings and LTCFs. Funding Recommendation: Inclusion in EU4HEALTH of a significant funding pot for MS to implement effective AMR programs
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Response to Evaluation and revision of the general pharmaceutical legislation

5 Apr 2021

Enhance Security of supply Medication shortages are not just a pharmacy problem; addressing shortages requires action on multiple fronts. But in the meantime healthcare provider organizations must have the right protocols , technology and systems in place to manage drug shortages. Many healthcare provider´s supply chains are not supporting good management of medicines shortages. They can be inefficient and wasteful , burdened by low visibility of inventory , a manual, time-consuming process of ordering, replenishing and storing inventory. Digital technology , including automation and computerised/IT inventory management systems, is important in key areas of medication supply management: better visibility of inventory , more accurate forecasting, and a means to help to reduce costs throughout the healthcare continuum. New European Regulation should include the mandatory implemetation of computerised/IT inventory management systems at acute care level to be able to support one Regional/National/European telematic infrastructure to increase demand visibility and to prevent and better managing of medicines shortages. Enviromental sustainability Adherence to medication and medication safety are becoming more and more important in EU. Unidose/multidose preparation involve removing the drugs from their original packaging, and repackaging them in a container other than their authorised packaging . Doses are inserted into the compartments of a pill organiser or repackaged in unitdose/multidose rellabeled transparent pouches, mainly for oral solid forms (tablets,capsules). The introduction of dose preparation raises several clinical issues . What is the drug’s shelf life once removed from its original packaging? How can this shelf life be determined? Are some substances or pharmaceutical forms incompatible with dose preparation? etc. covered in guidelines. They drive as well enviromental and cost issues: Enviromental:today pharma manfucturers in EU supply ALL medicines in blíster packs. To prepare unidose/multidose pouches , then blisters are cut and then repackaged in plastic bags. This system increase waste of plastic materials, and so carboon footprint from plastics. If Pharma manufacturers would supply bulk tablet containers of medication for unidose/multidose repackaging this would reduce the plastic waste and so the carboon footprint. Cost:several expensive processes are taking place in the hospitals and community pharmacies to cut blisters to be repackaged. If Pharma manufacturers would supply bulk tablet containers of medication for unidose/multidose repackaging then o blíster cutting would be required, reducing the cost of medicines, making them more affordable for the healthcare systems. New European Regulation should include the request to pharma industry to supply bulk tablet containers for unitdose/multidose repackaging to reduce costs (more affordable) and carboon footprint (less plastic waste). Patient safety The main adverse events in EU acute care settings is medication errors. Many of those errors drive harm in the patients and families , but as well in the healthcare professionals that are involved in the errors (so called second victims). Errors can take place in the different phases of medication management : prescription, preparation,dispensing and administration. Nowadays, the level of digital technology enables systems that guarantee the traceability of medication in hospitals to prevent errors, including, among others: automated storage and electronic dispensing cabinets systems, electronic prescription (CPOE) systems, electronic preparation systems, bar-coded single-dose systems, barcoded medication administration systems (BCMA) and smart medication administration pumps. New European Regulation should include the request to EU acute care settings to implement medication traceability systems to cover the whole medication management process to prevent medication errors.
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Response to Europe’s Beating Cancer Plan

25 Feb 2020

Uneven access to preventive measures, treatment and care The arsenal of anticancer therapies is only as good as the deployment of it. In the age where Germany is looking to hire nurses from Mexico, UK has 42,000 nursing and 10,000 medical vacancies– the challenge is how to achieve better access with increasingly scarce resources.Technological Innovation to improve efficiencies, reduce wastage and increase the exchange of information as well as reduce the administrative burden of existing clinical staff (only 40% of nursing time is spent with patients) will be crucial to ensure that existing finite clinical resources in terms of staffing is deployed in areas where they are needed most and not wasted. Patient safety Europe´s beating cancer plan draft does not include any reference to patient safety. Nevertheless it is one of the main issues for cancer patients , driving significant inequalities across Europe. The main risks relate to: Medication errors: It has been estimated that in some countries approximately 6-7% of hospital admissions appear to be medication related, with over two-thirds of these considered avoidable . They constitutes the highest adverse events in hospitals, not only in terms of number, but as well in morbidity and mortality .The summary of the studies published in Boston show that IT innovation can reduce medication errors by around 60%. It clearly demonstrates that the introduction of medication traceability systems , like electronic like electronic prescription , preparation and barcoded medication administration (BCMA) systems have a very significant impact. Vascular access adverse events: With over 100,000 doses of chemotherapy and in excess of 1,000,000 intravenous (IV) infusions given every day in Europe , keeping adverse events and complications of these procedures to a minimum is important both for the patients and the healthcare systems .The main adverse event in infusion of cancer treatment is extravasations. Studies show a prevalence between 0,1-6%. Recent data in Spain suggest more than 1000 extravasations each year in oncology units with one associated costs that could reach $ 114 million.Bacteremia (CRBSI) and Phlebitis are very common vascular access adverse events, with reported CRBSI ranging from 0.05 to 6.8 infections per 1000 catheter days 4 as well, in cancer patients. Lack of guidance in the form of protocols/algorithms for the right selection of vascular access in cancer settings and lack of awareness and training for healthcare professionals are the main drivers of vascular access adverse events in cancer. Healthcare-associated infections: Some types of cancer can damage the immune and blood systems or change the way they work. In most cases it’s not the cancer itself but the cancer treatment that changes the immune system. Good infection prevention program, with prevention measures specific for patients, healthcare personnel and visitors in inpatient and outpatient cancer settings is extremely important to reduce risk of infection for cancer patients. The standards of care and IT systems in cancer settings across Europe varies significantly by Country, by Region within the Country and even across healthcare settings within the Country. Therefore the likelihood for cancer patients of suffering one adverse event varies significantly across countries and even within the countries. There is a need to regulate the minimum standards of care and IT systems in healthcare settings for cancer treatment and care in Europe , to ensure all European citizens have the same level of protection, independently of the Country, Region or Healthcare institution where they are treated.
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