ALERT HEALTHCARE & PHARMACEUTICALS - Cliffe Dekker Hofmeyr

Page created by Alice Fletcher
 
CONTINUE READING
ALERT HEALTHCARE & PHARMACEUTICALS - Cliffe Dekker Hofmeyr
17 MAY 2021

HEALTHCARE &
PHARMACEUTICALS
ALERT

IN THIS ISSUE >
 Telemedicine: Band-aid or
 long-term solution?
 COVID-19 highlighted the necessity of having
 a viable telemedicine regime as a ‘safety net’ to
 ensure continued access to healthcare services
 whilst maximising social distancing. We now
 have an opportunity to better understand
 the challenges and exploit the benefits of
 telemedicine services.
ALERT HEALTHCARE & PHARMACEUTICALS - Cliffe Dekker Hofmeyr
HEALTHCARE &
 PHARMACEUTICALS

                                             Telemedicine: Band-aid or
                                             long-term solution?
                                             COVID-19 highlighted the necessity of         Regulation of telemedicine in
                                             having a viable telemedicine regime as a      South Africa
The aim of telemedicine                      ‘safety net’ to ensure continued access
                                                                                           COVID-19 necessitated a relaxation of
                                             to healthcare services whilst maximising
is not to eradicate                                                                        the rules governing telemedicine. As an
                                             social distancing. We now have an
face-to-face consultations                   opportunity to better understand the
                                                                                           infection-control solution, telemedicine
                                                                                           helps reduce health care workers’
with healthcare                              challenges and exploit the benefits of
                                                                                           contact with patients, whilst enabling
workers, but to improve                      telemedicine services.
                                                                                           vulnerable groups to receive certain
accessibility and efficiency                 To do more with less, beyond the              healthcare services during self-isolation.
of healthcare services.                      pandemic, innovative developments in          Telemedicine in South Africa is regulated
                                             technology can increase access to care        in terms of, amongst others, the General
                                             (where appropriate) and lower systemic        Ethical Guidelines for Good Practices
                                             costs, particularly for vulnerable groups     in Telemedicine, issued by the Health
                                             and those in underserviced rural areas,       Professions Council of South Africa
                                             where face-to-face care is not a viable or    (HPCSA) in 2014 (2014 Guidelines).
                                             efficient option.
                                                                                           The HPCSA is a statutory body overseeing
                                             What is telemedicine?                         the education, training, and registration
                                                                                           of health professionals, aiming to among
                                             Terms such as telehealth services,
                                                                                           other things, ensure that practitioners
                                             digital health and e-health are often
                                                                                           maintain professional and ethical
                                             used synonymously with telemedicine.
                                                                                           standards. Understandably, there is a
                                             Examples include specialists exchanging
                                                                                           need to regulate healthcare practitioners’
                                             a patient’s medical history via messaging
                                                                                           conduct, especially when dealing with
                                             apps, telephonic or video consultations
                                                                                           patients remotely. Having certain checks
                                             between patients and healthcare workers
                                                                                           and balances in place is desirable to
                                             and remote monitoring of patients.
                                                                                           ensure that the process is not abused to
                                             Telehealth is defined by the World Health     the detriment of patients, for example,
                                             Organisation (WHO) as the remote              through over-servicing. Rules can help
                                             delivery of healthcare services by all        maintain standards and ensure that the
                                             healthcare professionals, where distance      quality and safety of patient care is not
                                             is a defining factor, using information       unnecessarily compromised.
                                             and communication technology (ICT)
                                                                                           Under the HPCSA’s initial paradigm all
                                             for the exchange of information for the
                                                                                           telemedicine services should involve a
                                             diagnosis and treatment of diseases and
                                                                                           healthcare provider where there is an
                                             injuries, research and evaluation, and
                                                                                           actual face-to-face consultation and
                                             for the continuing education of health
                                                                                           physical examination of the patient
                                             professionals.
                                                                                           in a clinical setting by a ‘consulting
                                             The aim of telemedicine is not to eradicate   practitioner’, who will communicate the
                                             face-to-face consultations with healthcare    information to the ‘servicing practitioner’
                                             workers, but to improve accessibility and     to provide the necessary assistance.
                                             efficiency of healthcare services.
                                                                                           Accordingly, the 2014 Guidelines barred
                                                                                           first-time consultations between a patient
                                                                                           and healthcare worker and meant that only
                                                                                           telemedicine consultations facilitated by

2 | HEALTHCARE & PHARMACEUTICALS ALERT 17 May 2021
HEALTHCARE &
 PHARMACEUTICALS

                                             Telemedicine: Band-aid or
                                             long-term solution?...continued
                                             one healthcare practitioner with another      further announcements on the continued
                                             healthcare practitioner (on behalf of         use of this guidance after the pandemic
Telemedicine is frequently                   the patient) were allowed, with limited       subsides. This presents an opportunity
                                             exceptions if there was already an existing   for expanding the responsible use of
judged against the                           relationship between the healthcare           telehealth services.
counterfactual of                            worker and the patient.
                                                                                           One can expect businesses and
face-to-face care, where                     When the national lockdown commenced,         practitioners which have invested in
it may fall short. In                        and only for the limited duration of          technology to support telehealth during
South Africa, however, the                   the COVID-19 pandemic, the HPCSA              the pandemic will likely resist a complete
lived experience of the                      minimally relaxed its stance by issuing       reversal of the relaxations.
                                             guidance which replaced the reference
counterfactual is often                      to “telemedicine” with “telehealth”, which
                                                                                           Benefits
no or less care due to                       definition now included telepsychology,       Telemedicine is frequently judged against
access constraints.                          telepsychiatry, and telerehabilitation,       the counterfactual of face-to-face care,
                                             amongst others. The requirement for an        where it may fall short. In South Africa,
                                             already established practitioner-patient      however, the lived experience of the
                                             relationship remained, except for             counterfactual is often no or less care due
                                             telepsychology and telepsychiatry. Critics    to access constraints. Telemedicine can
                                             referred to a lack of clarity in respect of   enable healthcare workers, particularly
                                             the length of time and other requirements     scarce specialists, to reach patients in
                                             needed to “establish a relationship”          remote and rural locations which they
                                             between the patient and the physician.        would not normally be able to access.
                                             Despite the hard lockdown having              Pre-pandemic, the National Department
                                             commenced, the HPCSA specifically             of Health, in its e-health strategy
                                             advised against telephone and/or virtual      (2012 – 2016) recognised the potential
                                             consultations for new patients (HPCSA         of telemedicine “as a tool that could
                                             Guidance Note 26 March 2020).                 bridge the gap between rural health and
                                                                                           specialist services.”
                                             This limited relaxation met resistance
                                             from the medical fraternity, nudging the      An additional important benefit is the
                                             HPCSA to issue further amendments in          role telemedicine can play in upskilling
                                             order to allow first-time consultations       health care workers, by using technology
                                             between clinicians and patients without       as a training tool; a huge gain in South
                                             an established relationship, provided         Africa where we face a healthcare human
                                             such consultations are in the clinical        resources crisis and an inequitable
                                             best interest of patients. (HPCSA Notice      geographic spread of available specialists,
                                             3 April 2020)                                 amidst a high burden of disease.

                                             When announcing the aforesaid                 There is also the potential to lower costs
                                             relaxations, the HPCSA cautioned that the     and improve patient outcomes, particularly
                                             revised provisions on the use of telehealth   in under-resourced areas.
                                             are only applicable during the COVID-19
                                             pandemic and indicated it would make

3 | HEALTHCARE & PHARMACEUTICALS ALERT 17 May 2021
HEALTHCARE &
 PHARMACEUTICALS

                                             Telemedicine: Band-aid or
                                             long-term solution?...continued
                                             Challenges                                     Regarding telemedicine across country
                                                                                            borders, the 2014 Guidelines provide
                                             Telemedicine is not without its risks
Implementing the                             and challenges.
                                                                                            that practitioners serving South African
                                                                                            patients must be registered with the
lessons learnt requires                                                                     equivalent regulatory bodies in their
                                             Most obviously of concern are inaccurate
the HPCSA’s stewardship                      clinical diagnoses in a virtual world, for     original countries, as well as with the
in reimagining the                           example, if patients are unable to correctly   HPCSA. This limits the potential for
expansion of telemedicine                    describe their symptoms, particularly          South Africa to obtain exposure to
                                             where there are language barriers,             international expertise, particularly for rural
regulation in a manner                       and there is no physical examination.          communities. However, in a subsequent
that responsibly                             These challenges are less prevalent            media statement dated 9 March 2020, the
manages patient risks                        for certain specialities, such as mental       HPCSA makes temporary allowance for
                                                                                            healthcare practitioners registered outside
without foregoing the                        health consultations.
                                                                                            of South Africa to practice cross-border
potential benefits.                          Another considerable obstacle is the
                                                                                            telemedicine as long as they are registered
                                             ownership and transfer of patient data, in
                                                                                            with an equivalent professional body in
                                             the light of the absence of an implemented
                                                                                            the country in which they are based. It is
                                             system for a single electronic interoperable
                                                                                            hoped that this amendment can remain
                                             health record. For example, the 2014
                                                                                            post COVID-19, for appropriate use, so
                                             Guidelines require informed consent for
                                                                                            that South Africa can continue to leverage
                                             the use of telemedicine technologies to be
                                                                                            opportunities from international health
                                             obtained in writing from the patient and
                                                                                            human resources.
                                             a witness, that a duplicate of this consent
                                             form be kept as part of the patient record     From a pragmatic perspective, South
                                             and a copy be shared with the patient. This    Africa’s electricity load shedding epidemic
                                             has been criticised as being impractical,      and the high costs of data may present
                                             especially, if the patient is in a remote      connectivity challenges. However, this
                                             location, is illiterate, or incapacitated      does not mean that telemedicine in and
                                             and urgent advice is required. However,        of itself is a dead-end, but rather that
                                             hanging in the balance are the rights          eradicating total inequality in healthcare
                                             of patients to informed consent and            delivery will be unlikely.
                                             privacy, as well as the requirement for
                                                                                            Converting the band aid into a
                                             POPI compliance.
                                                                                            long-term solution
                                             Reimbursement models are an important
                                                                                            Implementing the lessons learnt
                                             factor in healthcare worker uptake of
                                                                                            requires the HPCSA’s stewardship in
                                             telemedicine solutions. It is understood
                                                                                            reimagining the expansion of telemedicine
                                             that telemedicine consultations are
                                                                                            regulation in a manner that responsibly
                                             broadly still reimbursed at lower rates than
                                                                                            manages patient risks without foregoing
                                             face-to-face consultations. A delicate
                                                                                            the potential benefits. Stakeholder
                                             balance must still be found between
                                                                                            involvement and buy-in through the
                                             reimbursing healthcare workers fairly
                                                                                            participation of patients, healthcare
                                             for time spent in delivering high quality
                                                                                            professionals and providers, funders,
                                             telemedicine services versus losing
                                                                                            technology providers, and the Department
                                             potential cost efficiencies.
                                                                                            of Health, will be critical.

                                                                                            Susan Meyer and Simone Nel

4 | HEALTHCARE & PHARMACEUTICALS ALERT 17 May 2021
OUR TEAM
For more information about our Healthcare & Pharmaceuticals sector and services in South Africa and Kenya, please contact:

                Susan Meyer                                        Etta Chang                                          Imraan Mahomed
                Sector Head                                        Director                                            Director
                Healthcare & Pharmaceuticals                       Corporate & Commercial                              Employment Law
                Director                                           T +27 (0)11 562 1432                                T +27 (0)11 562 1459
                Competition                                        E etta.chang@cdhlegal.com                           E imraan.mahomed@cdhlegal.com
                T +27 (0)21 481 6469
                E susan.meyer@cdhlegal.com

                Sammy Ndolo                                        Tim Fletcher                                        Mashudu Mphafudi
                Managing Partner | Kenya                           National Practice Head                              Director
                T +254 731 086 649                                 Director                                            Finance & Banking
                  +254 204 409 918                                 Dispute Resolution                                  T +27 (0)11 562 1093
                  +254 710 560 114                                 T +27 (0)11 562 1061                                E mashudu.mphafudi@cdhlegal.com
                E sammy.ndolo@cdhlegal.com                         E tim.fletcher@cdhlegal.com

                Emil Brincker                                      Lara Granville                                      Christoff Pienaar
                National Practice Head                             Director                                            National Practice Head
                Director                                           Competition                                         Director
                T +27 (0)11 562 1063                               T +27 (0)11 562 1720                                Technology Media & Telecommunications
                E emil.brincker@cdhlegal.com                       E lara.granville@cdhlegal.com                       T +27 (0)21 481 6350
                                                                                                                       E christoff.pienaar@cdhlegal.com

                André de Lange                                     Quintin Honey
                Sector Head:                                       Director                                            Lucinde Rhoodie
                Agriculture, Aquaculture & Fishing                 Corporate & Commercial                              Director
                Director                                           T +27 (0)11 562 1166                                Dispute Resolution
                Corporate & Commercial                             E quintin.honey@cdhlegal.com                        T +27 (0)21 405 6080
                T +27 (0)21 405 6165                                                                                   E lucinde.rhoodie@cdhlegal.com
                E andre.delange@cdhlegal.com

                                                                                                                       Njeri Wagacha
                                                                                                                       Partner | Kenya
                                                                                                                       T +254 731 086 649
                                                                                                                       T +254 204 409 918
                                                                                                                       T +254 710 560 114
                                                                                                                       E njeri.wagacha@cdhlegal.com

BBBEE STATUS: LEVEL TWO CONTRIBUTOR
Our BBBEE verification is one of several components of our transformation strategy and we continue to seek ways of improving it in a meaningful manner.

PLEASE NOTE
This information is published for general information purposes and is not intended to constitute legal advice. Specialist legal advice should always be sought
in relation to any particular situation. Cliffe Dekker Hofmeyr will accept no responsibility for any actions taken or not taken on the basis of this publication.

JOHANNESBURG
1 Protea Place, Sandton, Johannesburg, 2196. Private Bag X40, Benmore, 2010, South Africa. Dx 154 Randburg and Dx 42 Johannesburg.
T +27 (0)11 562 1000 F +27 (0)11 562 1111 E jhb@cdhlegal.com

CAPE TOWN
11 Buitengracht Street, Cape Town, 8001. PO Box 695, Cape Town, 8000, South Africa. Dx 5 Cape Town.
T +27 (0)21 481 6300 F +27 (0)21 481 6388 E ctn@cdhlegal.com

NAIROBI
CVS Plaza, Lenana Road, Nairobi, Kenya. PO Box 22602-00505, Nairobi, Kenya.
T +254 731 086 649 | +254 204 409 918 | +254 710 560 114 E cdhkenya@cdhlegal.com

STELLENBOSCH
14 Louw Street, Stellenbosch Central, Stellenbosch, 7600.
T +27 (0)21 481 6400 E cdhstellenbosch@cdhlegal.com

©2021 10021/MAY

                                                                                                 HEALTHCARE & PHARMACEUTICALS | cliffedekkerhofmeyr.com
You can also read