APEC codes of business ethics for medical technology industry

In late 2011 the leaders of the APEC economies agreed to a proposal from the Ministers for Small and Medium Enterprises to support the development of a code of business ethics for the medical device industry in the APEC region. The purpose of this initiative is to reduce the disadvantage which SME companies can experience when competing in an unlevel market place. A code of business ethics is seen as one way to address the issue.

The agreement of the leaders followed work undertaken in early 2011 when representatives of the medical technology sector met in Kuala Lumpur to develop the framework for the code. This became known as the KL Principles. Last week work began on drafting the code itself with experienced industry compliance managers and industry association leaders working with associations from across APEC. Over the next year the codes will be further refined and followed by train the trainer programs to ensure a broad-based rollout. At the same time work will be undertaken with governments to develop awareness of the cods and to ensure  implementation within each economy.

This work is welcomed by MTAA. It will provide  strong guidance in the APEC region on the  way in which companies and healthcare professionals and other customers can operate ethically in their dealings with each other.

Anne Trimmer
Chief Executive Officer
Medical Technology Association of Australia

All medical technology companies in Australia have been asked to participate in the MedTech Market in Australia survey. This is an important project that will allow MTAA, companies and the public a greater understanding of the medtech industry in Australia.

MTAA has commissioned UltraFeedback to conduct the survey. De-identified results will be included in the next edition of the MTAA Industry Factbook.

The survey is very brief. The average time taken by the 120 companies that have already completed the survey is 12 minutes.

If you wish to participate, or to confirm who in your organisation has been contacted, please contact Helena van de Linde at UltraFeedback on helena.vandelinde@ultrafeedback.com or P: (03) 9819 2086.

According to recent European research on corporate reputation the medtech industry is well respected amongst the 300 patient groups involved in the survey, coming second only to retail pharmacy but ahead of the pharmaceutical and for-profit health insurance industries. The survey ranked highest the industry’s high-quality, useful products; innovation and ensuring patient safety.

The results correlate to MTAA’s own consumer research conducted in 2011. The consumer survey found that the majority of respondends believe the industry is very important. Other survey outcomes include health consumers wanting improved access, reduced costs and more patient information from medtech companies. The majority of health consumers receive information about medical technologies from their GP or surgeon, and research the internet. However, the survey found that over 70% want to learn more about their procedure or surgery even though satisfaction levels of past procedures were high.

The survey results are available from the member section of the MTAA website. Members need to logon and follow the links to Market Tools and Resources/Surveys.

The South Australian Health Department has issued a compulsory directive on interactions between SA Health employees and the therapeutic goods industry (December 2011). The directive sets out requirements for both SA Health staff and industry in a number of areas including:

• Industry sponsored research projects and clinical trials
• Industry sponsored meetings and events
• SA Health staff who are engaged to act as industry consultants.

Some key points about the directive:

• It requires medical technology representatives to abide by the MTAA Code in all interactions with SA Health employees
• The directive goes further than the Code on some issues- for example it prohibits gifts of any nature directly to SA Health staff
• SA Health can issue a company a formal warning for a breach of the directive and may also lodge a complaint under the MTAA Code. In the case of repeated infringements, the directive states that these may jeopardise future business dealings with SA Health.

Companies can access the South Australian Health Directive on Interactions between SA Health & Therapeutic Goods Industry from the SA Health website.

The South Australian government has released a manufacturing green paper seeking industry feedback on how to plan for the transformation of the manufacturing sector to an advanced high value future. The green paper has identified four themes including: providing information to SMEs about industry and new market opportunities, re-designing procurement systems that reward innovation, establishing clusters with industry, government and academia and promoting skills and leadership. Submissions are due on Monday May 7, please contact Industry Policy Manager Fiona Landis at E: flandis@mtaa.org.au or P: (02) 9900 0650 if you are interested in this process.

MTAA’s next MedTech Seminar - Has Your Company Planned for All the Impacts from a Regulatory Adverse Event? will be presented by David McCredie and Elisabeth White, Partners, Baker & McKenzie on 24 May 2012 at the Kolling Building, RNSH, Sydney (4:30 – 5:30 pm followed by refreshments until 6:30 pm). Cliff Spong, Director Regulatory and Scientific Affairs, MTAA will facilitate the session.

This seminar will include issues to consider when an adverse event occurs such as: 

• ACCC product safety reporting requirements imposed by new Australian Consumer Law provisions and interplay with the Therapeutic Goods Act adverse event reporting regime
• Potential product liability exposure and practical tips for managing prospective claims
• Impact on clinical trials
• Communications with regulators, customers and healthcare practitioners
• Director, shareholder and stock exchange reporting requirements.

Please click here to register. Members will pay $75 and non-members $150.

With the introduction of the Federal Work, Health and Safety (WHS) Act 2011 effective from 1 January 2012, module 5.12 WHS Fundamentals is now available. It supports employees to gain an understanding of a number of principles, including workplace safety when working offsite in healthcare facilities. To register, please visit the MTAA website. The module can be found under Course 5.

Upcoming Training

For a snapshot of the next three months of training, please click here.

• 1.8 Introduction to the Regulation and Design of Clinical Investigations for Medical Technology in Australia (23 May, Sydney)
• 5.6 High Performing Teams (13 June, online)
• 2.3 Advertising Therapeutic Goods in Australia (27 June, Sydney)

E-learning

Module 3.3 Infection Prevention provides insight into infection prevention when working in the healthcare setting.

Module 5.11 Planning Projects explores general project management principles and how to apply these skills to the project planning processes during the initiate and plan phases.

Contact Details

If you would like to know more about other training opportunities that are available through MTAA, please view the interactive training MTAA on E: pd@mtaa.org.au or P: (+612) 9900 0650.

The Research Australia Awards recognize and celebrate achievement and contribution to health and medical research in Australia. Awards are presented for areas such as discovery, advocacy and philanthropy.

Following feedback from its membership Research Australia has decided to reinstate the Lifetime Achievement Award in 2012. The Award honours scientists and other members of the community for a significant lifetime commitment to supporting and promoting health and medical research. 

For questions please follow this web link or contact Melissa Harris on E: melissa.harris@researchaustralia.org

Nominations should reach Research Australia by no later than 1 June 2012.

The ACORN 2012 National Conference will be held on 23 May 2012 — 26 May 2012 at the Darwin Convention Centre.

MTAA Professional Development Manager Fiona Shipman will copresent on Medical company reps in the perioprative environment: A partnership model for putting the ACORN Standards into practice and Training medical company reps in the ACORN Standards as visitors to the preioperative environment: A partnership approach to improving patient outcomes.

The 2012 ARCS Sydney Congress will be held from 6 - 7 June 2012 at the Sydney Convention & Exhibition Centre, Darling Harbour. This year the conference consists of five streams of content for those in Clinical Research (Australia and Asia), Study Coordinators and Data Managers, Medical Affairs, Pharmacovigilance, Medical Writing, and Management.

Cliff Spong, MTAA Director of Regulatory and Scientific Affairs, is facilitating a session on Is GCP relevant for device trials? that includes members of the MTAA Clinical Investigations Forum.