ABIMED has just launched its Foreign Trade Committee (COMEX), which is linked to the Business Environment Sustainability Axis. The 1st ABIMED Comex Committee Regular Meeting took place on February 8th. The objective of the new committee is to deal with interest topics to the associates in the Foreign Trade area, with a view to improving the import processes. The work strategy will be put into practice through bimonthly meetings with a previously defined annual agenda. The 2023 meetings will take place in April, June, August, and October.
The agendas to be worked on in these meetings can be proposed by the members to the ABIMED coordination and sponsor. One week before the meeting, ABIMED will send an invitation to the members, informing them of the main agenda to be discussed. In order for everyone to have access to what was discussed at each of these meetings, the minutes, annexes, and presentations from each event will be made available on the Associate’s Portal. “The Association expects COMEX to be propositional on the topics and produce valuable content, and that this can advance the interest agendas to the sector in this area,” says Fernando Silveira Filho, CEO of ABIMED.
The agendas proposed to COMEX can be segmented into three groups. In the scope of the IRS, topics such as the Unique Portal; attributes and product catalog; and special regimes for equipment will be addressed. The proposal here is to bring in a representative of the agency, who can add consistent information about each subject to be addressed. In the Anvisa group, the topics initially proposed are Integrated AEO; LPCO; parts; and deadlines. And in the Sefaz group, the main topic is the agility of releases.
The meetings will take place at the entity’s headquarters, always at 2 PM. Write down the dates in your calendar so you don’t miss them:
April 12th, 2023 – 2nd Regular Meeting of the ABIMED Comex Committee
June 14th, 2023 – 3rd Regular Meeting of the ABIMED Comex Committee
August 09th, 2023 – 4th Regular Meeting of the ABIMED Comex Committee
October 11th, 2023 – 5th Regular Meeting of the ABIMED Comex Committee
ABIMED Campus prepares 2023 schedule
Inaugurated at the end of last year, the ABIMED Campus is an initiative linked to the Strategic Axis of Education and aimed at the specialized qualification for the development of employees from associated companies. In 2023, the training program directed to the needs of the medical devices sector will be intense, besides counting on institutional partners.
Resulting from a Technical Cooperation Agreement signed with the Integrated Manufacturing and Technology Center of the Brazilian Service for Industrial Learning (Senai/Cimatec), the ABIMED Campus has a wide offer of educational programs, covering all spheres of activity, from operational to management areas. The training is structured to offer specific training to meet the sector’s demands, by means of short term refresher courses, MBA in the corporate university model, and even graduate (masters and doctorate) and MBA.
Positive results
The first program offered by the ABIMED Campus, “Regulatory impact assessment in the health products life cycle”, was a great success, reaching an average of 82% in the participants’ general satisfaction index. The infrastructure was unanimously praised by the students, with the library and laboratories widely praised in the assessment, as well as the administrative process and the clarity of the information obtained about the academic part. The professors’ performance was also praised for their ease of communication and good rapport with the students during class time.
Overall, the first course met the expectations of both the organization and the students. The feedbacks were very satisfactory and, even with the excellent results, also pointed the direction to the aspects that need improvement in search of the high level of teaching quality required for the sector.
When technology works “miracles”
To what extent can technology contribute to improving people’s life quality and, going further, to curing serious diseases? There is no concrete answer to this question at this time, but what we do know is that the possibilities are many and surprising. To give just one example, we mention here the study of a group of neuroscientists from Switzerland and Germany who implanted a brain chip in a 34-year-old patient, a victim of amyotrophic lateral sclerosis, which paralyzed all the muscles in his body. After many years without being able to speak, the man is communicating again. Not by voice, but the device allows him to transmit messages to the medical staff using only the power of thought.
The chip was designed by the Wyss Center for Bio and Neuroengineering Research in Genebra. The technology, still in its early stages, consists of two chips, each with 64 tiny electrodes that are connected to the motor cortex, the area on the surface of the brain from which conscious commands to move muscles originate. By switching between two patterns of movement intentions, the man can answer “yes” and “no” to questions asked by physicians, and all communication is done based on this binary choice.
Of course, this clinical case mentioned represents a breakthrough out of the curve – at least for now. But technology has already brought great benefits to the medical field, even if, on a day-to-day basis, we are not able to realize it. This is the case, for example, with clinical data management systems, which is already a fundamental process for providing quality care to patients, as well as being an enabler for physicians and staff. Management is also in the background of the healthcare systems transformation, contributing to the telemedicine evolution. And, without a doubt, this also impacts on cost reduction by eliminating waste and rework.
Another aspect that technology is helping to drive is the development of clinical tests, which are becoming increasingly more accurate, ensuring that diagnoses are more precise and obtained in less time. Moving forward in this regard are also the latest technological resources that contribute to surgical procedures being less invasive and performed more quickly. Recent article published on the News Medical Life Sciences Portal points out the latest developments in health technology
Artificial Intelligence (AI): is being used in disease diagnosis as well as to provide customized solutions. For example, in systems processing thousands of CT scans in a mass detection scenario, as in the covid-19 pandemic. This saves radiologists and physicians in patient care, and provides complementary information and thus improves the diagnosis and monitoring accuracy.
Machine Learning: machine learning is being exploited in the pharmaceutical industry to identify new possibilities in drugs, as well as allowing real experiments to be performed through simulations, thus allowing reducing costs.
Robotic systems: with the use of AI and machine learning, this resource is already being used to replace humans in performing unskilled routine tasks. This frees up professionals to treat more patients with less time pressure.
Mobile Health: mobile health information and detection technologies, called mHealth (mobile Health) are gaining prominence. These tools can expand the ability to provide lower cost healthcare with better outcomes. For example, mHealth applications can promote the healthy behaviors adoption to help self-manage chronic diseases and reduce visits to the physicians.
Virtual Reality: increased and virtual reality is being used in new ways to, for example, make it more comfortable for sensitive patients to perform some surgical procedures; or to train medicine students in a more efficient way.
The Internet of Medical Things (IoMT): comprises a network of mobile devices and applications that track and prevent serious events in the chronic diseases course, connecting patients and physicians for better monitoring and management of such conditions. For example, portable electrocardiography (ECG) monitors can allow patients with problematic changes to be identified early enough to abort heart attacks.
Blockchain: the use of blockchain technology has the potential to improve the secure, convenient, and rapid sharing of health information between authorized providers and patients…
Nanotechnology: the development of nanotechnology has given rise to many innovative treatment systems, such as xenobots, the tiny self-replicating organic robots. A wide range of applications is open for nanotechnology in medicine, including nanobots for detecting diseases by passing microscopic blood vessels and drug delivery systems with nanoparticles to ensure more precise and effective treatments.
3D printing: the ability to build body parts such as artificial veins, implants, bionic prostheses, and customized surgical instruments is only part of the future with 3D printing.
Normative Resolution 518 brings gains for the operators management
December 31st, 2022 was the deadline for health operators with more than 20 thousand beneficiaries to adopt the guidelines of Normative Resolution 518, of April 29th, 2022, from the Brazilian Health Agency (ANS). Since January of this year, all operators are obliged to observe the parameters established in the rule, that is, to implement minimum practices of governance processes, risk management, and internal controls in the operation.
It has also become mandatory to annually send the Previously Agreed Procedures Report (PPA) to the ANS, a publication issued by an independent auditor, which details the adoption of the minimum practices of the previous year. The report will be evaluated to verify compliance with the requirements in the resolution. The PPA report must be sent attached to the Health Plan Operators’ Periodic Information Document (DIOPS) for the 1st quarter of the following year. But it is worth pointing out that sending the PPA is optional for small operators and self-management plans operated by a human resources department.
Updating the rule
RN 518 is an update to 2019’s RN 443, a change that aims to promote market improvement as a whole. The operators themselves, as well as the regulatory agencies, understand that good management will bring benefits to the entire sector, promoting gains in the system’s sustainability. In other words, the change adds the criteria for transparent and effective management, and reinforces the importance of compliance programs. The operators that do not comply with the RN 518 requirements will be subject to sanctions, especially the failure to send the PPA may generate penalties in the terms of RN 489/2022 and questionings by the ANS. The Agency is making available a publication with all the details about RN 518, which can be downloaded by clicking here.
Survey shows companies’ actions in ESG policies
With increasing pressure from stakeholders – including consumers – companies in all segments, not just in the healthcare sector, are beginning to understand that ESG policies must be increasingly consistent, and not just positive marketing. This point of view is corroborated by the CEO Outlook Brazil gathering, prepared by the global consulting firm KPMG in mid 2022 with the Brazilian leaders consultation of companies from different sectors. For 50% of the Brazilian respondents, taking a more proactive approach to social issues, such as increasing investment in living wages, human rights, and a just transition, is the main factor for accelerating their organizations’ ESG strategy in the next three years.
They also indicate as positive the implementation of a net zero strategy (20%), the delivery of an inclusion and diversity strategy to address equity in leadership (24%), and the increased implementation of assessment metrics and governance to develop a more robust and transparent approach to ESG (6%). And yet: 86% of Brazilian leaders are aware of the significant stakeholder’s demand for reporting and more transparency on ESG issues, especially from institutional investors.
It is not much different outside Brazil. And, in this case, with the focus on the health area. A survey conducted by the Health Research Institute (HRI), linked to the consultancy PwC Brazil, reveals the trends and actions of companies in the pharmaceutical and bioscience sectors around the ESG agenda. 32 organizations were consulted in order to identify what has been done so far.
More than half of the leaders in this sector who responded to a survey of U.S. executive leaders conducted by PwC said they expected to increase diversity and inclusion training (58%) and the publicity on the
topic (52%) in the next 12 months. Another 40% said that their organizations would increase the board members diversity. The analysis also provided insight into some of the measures taken by companies to develop their ESG programs.
In the Environmental scope, the following initiatives were listed: sustainable vehicle fleet; carbon neutrality in 5-10 years; advanced waste management; and manufacturing costs reduction, through investment in continuous manufacturing or other technologies.
In the Social realm, the following were mentioned: significant financial contributions to affordable medicines and therapies for underserved communities; early adoption and incorporation of diversity in clinical trials for research and development; supply chain resilience based on supplier diversity and risk assessment; efforts to improve product safety; and comprehensive D&I (diversity and inclusion) measures such as recruitment and mentoring programs.
Regarding Governance, companies indicated: comprehensive corporate social responsibility reporting to monitor and share measurable progress on ESG; ESG leadership appointment; gender and racial diversity on boards; pay equity wage goals; and ethics, compliance, and fraud policies.
Sustainability in Primary Care
Primary Health Care (PHC) has its own challenges. Routine consultations and exams, as well as the follow-up of chronic patients (such as those with heart disease and diabetes) requires the public system, in particular, to overcome some challenges in order not to overload the system. The “OECD Study of Primary Health Care in Brazil“, prepared in 2021 by the Organization for Economic Cooperation and Development (OECD), makes a detailed diagnosis of this problem and outlines guidelines for improving the public health care system for the Brazilian population. The goal is to identify the scope for Brazil to build a more solid PHC system while strengthening existing policies and practices to improve access and quality of care.
According to the publication, the introduction of the Unified Health System (SUS) in 1990 was a great achievement for Brazil, increasing access to services and reducing health inequalities. Through SUS, the Brazilian population has been able to benefit from free access to preventive primary care services provided by multidisciplinary teams of the Family Health Strategy (ESF), which have also contributed to changing a historically hospital-centered care system. Without a doubt, the Family Health Strategy expansion has brought measurable improvements in terms of child mortality rates, among other positive impacts. For example, Family Health Strategy is associated with a 45% reduction in hospitalization rates per 10,000 population from 2001 to 2016, mainly for conditions sensitive to Primary Care, such as asthma, gastroenteritis, cardiovascular and cerebrovascular diseases. Brazil also prioritizes spending on PHC: in 2019 about 16% of financial resources were allocated to this segment, which is a similar level to other OECD countries.
Despite this progress, points out the OECD study, the main indicators suggest that PHC in Brazil is not working efficiently. The country still faces the challenges of striking inequalities in access and quality of PHC, with severe workforce tightness. The growing burden of chronic non-communicable diseases, coupled with the expanding exposure to risk factors and the rapid aging of the population, will exacerbate the challenges that exist in this context.
In Brazil, some types of cancer, hypertension, and diabetes have screening and prevention strategies. However, there is more to be done to improve the depth and comprehensiveness of these strategies. The study points out that improved data systems and health literacy are complementary measures that should not be underestimated to encourage greater cancer prevention and screening. As for hypertension and diabetes screening, Brazil must further develop therapeutic itineraries, with a person-centered perspective, integrating all health professionals in different sectors.
There are also obvious deficiencies in access to high-quality PHC. Only 65% of the population is served by Family Health Strategy teams, and many patients ignore primary health care, seeking direct care in hospital outpatient specialties. There are still challenges to the digitalization of PHC, even though Brazil has made great strides toward digital transformation. In 2019, about 78% of PHC units had electronic patient record (PEP) systems. However, progress toward the effective use of digital PHC is still not ideal, with significant inequalities in the use of digital tool technologies among health workers and citizens.
The OECD study brings public policy recommendations to improve PHC in Brazil. With regard to the general improvement of the provision quality the following points were indicated:
Strengthen the data filtering system, with systematic patients’ registration in the Family Health Strategy’s, which guides patients to specialized care as needed through the referral system.
Encourage a greater coverage of PHC, ensuring that all municipalities are able to perform health care actions and services.
Develop educational programs in disease prevention and early diagnosis.
Collect a richer set of quality indicators across a wider range of preventive and chronic condition management activities (such as alcohol consumption, obesity, cancer screening, and mental health), including PHC experiences, and implement public reporting systems to allow patients to monitor the performance of each ESF.
Build accreditation systems around care standards for all ESF in order to assess their performance, identify areas that may require improvement, and provide support for such improvements.
Expand health care networks to prioritize integrated care for patients with multiple needs.
Fonte: Abimed, em 28.02.2023.