Tanya Vogt, SAMED’s executive officer, describes 2019 as a year when SAMED took particular care to canvas and reflect the views of members in order to ensure that the industry adequately responds to complex regulatory and healthcare industry developments. There were frequent communiques and surveys to members, and with assistance from SAMED committees, facilitation of 17 meetings or workshops. These enabled SAMED and member companies to jointly examine pertinent issues, including access to market, procurement, reimbursement, upcoming regulations, healthcare trends and the broader socio-economic factors that impact on the health service and application of medical technologies.

The association prepared forward-looking and robust positions that take account of the diverse nature of the medtech industry within this changing environment. It also used various platforms to express these positions to members, policy-makers and customers.

In addition to a highly successful annual conference at the end of July, SAMED hosted several major workshops to share information with members, allow members to provide input to SAMED, build capacity and engage with policy-makers, funders, procurement officials and senior health department managers.

These larger meetings were devoted to supply-chain management and related liaison with the Gauteng health department, national health insurance (NHI), the private sector Health Market Inquiry (HMI) and quality management systems.

This year, SAMED reinvigorated the focus on transformation by individual member companies and the entire industry. The association is helping the members consider and adopt strategies that go beyond the short-term, narrowly focused procurement-related requirements to transform. “Rather we want to rally around transformation as a vital contributor to South Africa’s continued socio-economic progress. The association supports transformation as an economic imperative and aims for the medical technology industry to be recognised as a benchmark of transformation,” says Tanya.

SAMED conducted a benchmarking analysis of compliant B-BBEE certificates and affidavits submitted by over 100 members. The documentation indicates that the average B-BBEE level among members with B-BBEE certificate currently positions them at 4.94, while companies with affidavits have an average level of 2.68 (where level 1 is the best and level 8 the least favourable). The average Black ownership across members that submitted the information was 26%, with average female Black ownership of 10,7%. The average points achieved across the five B-BBEE elements (ownership, management control, skills development, enterprise and supplier development and SED) also underperforms: it is 39.13 out of 109 maximum points – and this must improve to at least 40 points to ensure compliance.

These results indicate that many members have a steep road ahead in order to ensure their companies’ compliance with B-BBEE legislation. SAMED’s transformation committee will continue to lead this area of the association’s work.

Ethical marketing and business practices, as stipulated by the Medical Device Code, were another field of work that received major attention this year. SAMED and the Code Committee championed the launch of an anonymous whistle-blowing mechanism, managed independently on behalf of SAMED by Deloitte.
Anonymous whistleblowing hotline

Or e-mail: samed@tip-offs.com accompanied by a completed complaint form.
Emails must be accompanied by the complaint lodging form. This will assist SAMED to investigate the complaint.

The Code and the tip-off line were promoted among members and through various means to healthcare professionals. Most recently, SAMED has joined discussions that are part of the newly instituted Health Sector Anti-Corruption Forum, announced by President Cyril Ramaphosa in October, and is currently seeking the best way to support and be an active participant in this valuable initiative.

Regarding communication with external stakeholders, during the first half of 2019, the focus was on strengthening the newly formed Medical Device Forum as a platform for the industry and SAHPRA to communicate openly and continually about regulation. SAMED played a leadership role by proactively pursuing opportunities to discuss issues that were of concern to members, such as licencing and amendment to licences, processes for product registration and SAMED recommendation to avoid the requirement for a separate wholesaling license for companies that also manufacture and distribute products.

Another crucial matter where SAMED played advocacy, advisory and facilitation roles related to health technology assessments (HTA) and Discovery Medical Scheme’s intent to charge fees to conduct HTAs and PINS before it approved them for reimbursement. SAMED sought legal advice and consulted with local and international HTA experts in order to formulate and articulate the industry’s view. That a better way had to be found for assessing medical technologies and making the assessments useful to funders and customers nationally was underscored by the HTA-related findings and recommendations made by the Health Market Inquiry.

A key learning, says Tanya, was that SAMED is well-positioned to facilitate face-to-face communication and apply a collaborative, solution-driven mindset to matters that could set SAMED members against other stakeholders. “Our willingness to consider everyone’s views and discuss all aspects of a common challenge until we get to a mutually agreeable way forward is of major benefit to SAMED members.” A similar approach was adopted to finding sustainable answers to the long-standing public sector debt.

“As an industry that improves quality of care and health outcomes through continued innovation and novel products that enable diseases to be prevented, diagnosed and treated, this year we ensured that the voice of the medical technology companies was clearly heard and that it contributes to forward-looking policies and practices.

“We thank all the companies and our board members and committees for active participation and dynamic engagement with SAMED during the year. We are also grateful for the opportunities to meet with many stakeholders from the public and private health sectors and look forward to strengthening our collaborations in 2020,” concludes Tanya.