The future of the new GHTF: growing pains ahead?
This article was originally published in RAJ Devices
Regulators have called it a day for their collaboration with the industry in the Global Harmonization Task Force for medical devices and instead are seeking to develop "a regulator-led harmonisation and collaboration group"1,2. Is this development an acknowledgment of the growing importance of the work or of the growing criticism that regulators are too close to industry? Or is it both?
Eucomed, which was one of the industry associations represented on the GHTF steering committee, the overseeing board of the GHTF, believes it is both. We believe that, rather than ending the GHTF, regulators are seeking to redefine and modernise the GHTF or create something new with a view to embarking on worthwhile future work. This type of initiative deserves support as it can help open up a new next level of harmonisation and co-operation.
The announcement that regulators wish to bring the GHTF to an end came somewhat as a shock. While the need to reinvent the initiative was a common discussion point between the global industry and the regulators from the five founding regulatory members of the GHTF (Europe, the US, Japan, Canada and Australia), it was the manner in which regulators chose to deliver their decision that surprised not only the industry but also some European member states and seasoned GHTF observers.
Normally all decisions about the GHTF are taken at meetings of the steering committee, made up of equal representatives of regulators and industry, and chaired in rotation by each of the five founding regulatory members. This decision, however, was taken at a closed-door regulators' meeting in Washington, DC, in February this year. Regulators then delivered the decision in a co-ordinated communication to the five founding industry partners.
Although initially a little surprised and, dare one say, disappointed in the move, industry has had time to digest and examine the new direction and, it just might be the best way forward.
Eucomed has long called for a renewal and revitalisation of the GHTF. From a Eucomed perspective, any policies, actions or initiatives to improve access for patients and eliminate barriers to trade with third countries are to be supported. As a consensus-based informal collaborative partnership forum of regulators and industry, the GHTF has made significant strides in enhancing patient safety, promoting innovation and increasing access to safe, effective and high quality clinically beneficial medical technologies around the world. Thus, the GHTF initiative is of significant importance to the European medical technology industry.
The GHTF has prevented, and continues to prevent, a proliferation of globally divergent regulatory systems, a significant element in reducing costs for industry. Also, the GHTF, over the long term, does influence the harmonisation of the founding member systems. Examples include quality management systems, essential principles, summary technical documentation and vigilance.
Another more diplomatic rather than technical benefit is that GHTF is an excellent platform for global and bilateral dialogue, debate and understanding between senior industry representatives and government policy makers and regulatory agencies. Additionally, GHTF guidance also forms a basis for positions to support trade discussions and, in particular, reduction of technical barriers to trade.
After almost 20 years of activity, however, the work of GHTF, and indeed the organisation around it, needed to change. Much of the core work had been completed and the focus needed to move from aspirational guidance to implementable guidance and identifying new worthwhile areas for work. In addition, there was the emergence of other major economies and the development of the Asian Harmonization Working Party, mirroring and complementing the work of the GHTF.
This left the GHTF increasingly open to criticism. With the emergence of other major economies, the GHTF was being accused by some as being a closed shop and remiss in the implementation of its own guidance. In terms of policy and priorities, the GHTF seemed to be more focused on document control and meetings rather than strategic steering with resulting harmonisation benefits. Added to this, in some quarters more than others, regulators have come under increased pressure from media and other sources with claims that they are too close to the industry they regulate. All this was beginning to tarnish the original lofty goals of harmonisation.
What was and is needed is a fundamental rethink and refocusing of the work, either within a reorganised GHTF or based on a whole new platform. We should learn from what worked and what did not work.
One key lesson learned is that the GHTF would have benefited from a clearly stated political commitment and vision at a high level. While there is no doubting the commitment of the past and present GHTF representatives, all this good work has been done on a voluntary basis with an implicit rather than explicit blessing of their political masters within a set framework on trade and public health. Without this, the policies that the GHTF pursued were always going to run against the tide of legal and technical difficulties barring implementation.
A second lesson is avoiding the mistake of agreeing to embark on a piece of work and committing regulator and industry resources where it was not already clear whether all members could actually implement the outcome. A certain amount of due diligence could have thwarted a lot of the criticism about non-implementation by founding members. In this context, any new GHTF should encourage and seek to accelerate convergence between the five founding members.
A third lesson is to embrace the global nature of what the GHTF created. The high quality of the work done by the GHTF has helped third countries and emerging economies leap-frog ahead in terms of health policy and regulation of medical devices. But with the membership limited to the founding five, enthusiastic others had to form their own groupings and seek observer status at the GHTF in order to continue to grow. This situation is at odds with the global nature of the medical device business and indeed the global desire by governments for a globally high level of health protection. To be truly global and to avoid divergence by regional groups, the GHTF needs to open membership to other regions committed to harmonisation to the same high level, eg to the AHWP.
Eucomed is supportive of the new developments that regulators are seeking. A revitalised platform can help address the criticisms of the past and lead to even further improvements. Harmonisation is important. As we have experienced in a Europe of 27 EU and four European Free Trade Association member states, harmonisation of regulatory rules yields not only full and open access to needed technologies for citizens but also better quality and choice and more effective and efficient use of regulatory and industry resources. As such, Eucomed also believes that industry, along with other new stakeholders such as patients and healthcare professionals, is a legitimate stakeholder and is keen to play its role in future plans.
References
1. Statement from the GHTF Chair: Update on Future Directions of GHTF, 28 March 2011, www.ghtf.org
2. End in sight for GHTF; new regulators-only forum on horizon, Regulatory Affairs Medtech, 2 March 2011
John Wilkinson is chief executive of European medical technology industry association Eucomed and John Brennan is the association's director regulatory and technical affairs. Website: www.eucomed.org. Email: