Health Canada to require all commercially reprocessed single-use medical devices to comply with Canada’s Medical Devices Regulations

Quebec amends its Code of Ethics of Physicians

PULSEWINTER 2015

Canada’s Innovative Medical Technology Industry Newsletter

OHIC Report Provides Transformative Health Innovation

Direction to Ontario Government

Ontario doctors vs. the Ontario government: diagnosing the challenges of negotiation

PULSE

03 President’s Message

04 Ontario Health Innovation Council (OHIC) Report Provides Transformative Health Innovation Direction to the Ontario Government

06 Health Canada to require all commercially reprocessed single-use medical devices to comply with Canada’s Medical Devices Regulations

07 Quebec amends its Code of ethics of physicians

9 Mise à jour du Code de déontologie des médecins

11 Ontario doctors vs. the Ontario government: diagnosing the challenges of negotiation

13 Recent Highlights

14 2015 Mercer Life Sciences Compensation Survey

15 Patent News

16 2015 MEDEC MedTech Conference

Contents

All rights reserved. The contents of this publication may

not be reproduced by any means, in whole or in part,

without the prior written consent of the association.

PRESIDENT’S MESSAGE

Welcome to the first issue of Pulse for 2015! Last year, through our collective efforts, our association had many accomplishments that were reason for us to be proud and have laid the groundwork for positive change in our industry for years to come. This issue highlights two such accomplishments that provide me with a great deal of optimism for our industry in Canada.

First, the recommendations from the Ontario Health Innovation Council (OHIC) truly have the potential to positively change the way that our industry operates in Ontario. If the report’s recommendations are implemented, I believe that they can improve the adoption of medical innovations, facilitate the creation procurement processes are suited to the unique value offering of medical technologies and grow the province’s medtech industry.

MEDEC, in collaboration with our industry partners, is currently engaging with the Ontario government so that they understand the value of implementing OHIC’s recommendations and we are confident that the government will indicate how they will proceed soon. It is safe to say that MEDEC’s positive relationship with the government and our collective advocacy on behalf of our industry played a real part in the creation of OHIC.

The second accomplishment that is highlighted in this issue is Health Canada’s recent decision to require all commercially reprocessed single-use medical devices to comply with Canada’s Medical Devices Regulations by September 1st, 2016. This was a long-outstanding patient safety issue and the Reuse of Single-Use devices task force has been persistent in their advocacy on this file. We are very pleased with this decision by Health Canada.

I am confident that 2015 will be a great year for MEDEC and our industry. Our association’s strategic planning process for the upcoming year will soon be wrapping up and it will provide us with a roadmap going forward to ensure that our efforts are highly focused on areas that will deliver the most benefit to our members and to Canadian patients. I look forward to continuing our work together this year.

Brian LewisPresident and

CEO

Optimism for MedTech in 2015

Brian Lewis President & CEO

Klaus Stitz Vice President, Regulatory Affairs

Nicole DeKort Vice President, Government Affairs, Ontario and Federal

Benoit Larose Vice President, Quebec

Iris Crawford Vice President, Finance & Operations

Debbie Gates Executive Assistant to the President & CEO

Natasha Alves Administrative Coordinator

Robert (Bob) Rauscher Vice President, Western Canada

Gerry Frenette Executive Director, Public and Member Relations

405 The West Mall, Suite 900 Toronto, Ontario M9C 5J1

416.620.1915 1.866.58.MEDEC

www.medec.org

MEDEC Staff

The innovation journey is just that – a journey with incremental and breakthrough innovations (and opportunities in between) that improve products, processes and people and in the healthcare ecosystem – improve patient care. But the innovation journey requires leadership, vision and persistence given that innovation should never stop, but keep adding value along the health care value chain.

Ontario has been fortunate enough to demonstrate the leadership required to take health care innovation to the next level. On December 19th, the Ontario Health Innovation Council (OHIC) released its eagerly awaited recommendations to the Ontario government in its report, The Catalyst: Towards an Ontario Health Innovation Strategy. We believe that the report’s recommendations have the potential to drastically improve the environment for the medical technology industry and health innovation in Ontario.

The Council was created by Premier Wynne’s government in November 2013 to provide recommendations on how to “accelerate the adoption of new technologies in (Ontario’s) health care system and support the growth and competitiveness of Ontario’s health technology sector”. The Council, comprised of many of our key leaders in the Ontario health care ecosystem, embarked on a year-long (short-term) journey that included significant input from health care stakeholders, providers, purchasers and the public. The final recommendations from OHIC reflect a carefully considered approach to improving the innovation journey in Ontario and set a precedent across Canada (and internationally) to consider similar areas of improvement.

Below are summarized versions of the report’s recommendations to the government:

1. Establish an Office of the Chief Health Innovation Strategist (by mid-2015)

The Office of the Chief Health Innovation Strategist (OCHIS) will provide the leadership to make Ontario a major centre for health technology innovation. The OCHIS will work with government and other stakeholders from across the province to identify health system priorities and population needs. It will also work to align innovation efforts with these priorities and needs.

Source: Page 9 of the OHIC Report

Ontario Health Innovation Council (OHIC) Report Provides Transformative Health Innovation Direction to the Ontario Government

by Saurabh Popat, Chair, MEDEC Ontario Committee

Thank You

Many of our medtech sector leaders were involved and engaged with OHIC and we would like to them for their leadership – in particular Neil Fraser (Medtronic) and Peter Robertson (GE Healthcare). Many others were also very engaged and provided significant ideas and support and we thank them for their efforts and will continue to rely on the entire sector as the innovation journey continues.

2. Appoint Innovation Brokers to Connect Innovators with Resources (within a year of establishing OCHIS)

Innovation Brokers will connect innovators with the resources needed to advance health technology innovations into practice. These brokers will be a single point of access to health system decision makers, test sites for gathering feedback from patients and clinicians, and funding for development and commercialization of innovative health technologies. They will also work with the OCHIS to coordinate, integrate, and ensure alignment of innovation with health system priorities and population needs.

3. Invest in Made-in-Ontario Technologies (initial tranche of evaluations before end of 2015)

A four-year, $20-million Health Technology Innovation Evaluation Fund should be created to support pre-market evaluations and early adoption of home-grown innovative health technologies, facilitating evaluation of innovations in specific care settings and across the health sector.

4. Accelerate the Shift to Strategic, Value-Based Procurement (as quickly as possible)

To better support the development and adoption of innovation, a broad range of key stakeholders should be engaged in defining health care procurement priorities and strategies on an early and ongoing basis. Stakeholders will focus on addressing health system priorities, population needs and creating value (e.g., improved health outcomes, enhanced access, reduces costs, new investment and job creation) rather than the day-to-day purchasing of specific goods and services. Finally, the health system will invest in the skills, knowledge and competencies needed to enable strategic procurement. The direction includes a vision where the health system is more integrated with fewer procurement organizations and a greater number of smaller organizations actively participating in GPOs and SSOs.

5. Create Incentives and Remove Barriers to Innovation (initiated within a year of establishing OCHIS)

The OCHIS will conduct targeted, evidence-based reviews of opportunities presented by emerging health technology innovations and provincially funded programs and organizations. The policy reviews will address the incentives and barriers to innovation, while the program and organization reviews will ensure the innovation ecosystem

remains aligned with current health system priorities and population needs.

6. Optimize the Pathways to Adoption and Diffusion of Innovation (as soon as OCHIS is established)

The OCHIS, working with stakeholders throughout the innovation ecosystem, will develop, evaluate, and coordinate pathways for the adoption and diffusion of innovative health technologies across the full continuum of the health sector (e.g., including health promotion, community care, hospitals, and home care).

The Ontario Government has indicated that they will examine the recommendations, and will determine an implementation plan that aligns with government priorities – which may or may not also require budget approval to support certain initiatives.

Nonetheless, MEDEC has received indications from the government that they are generally very supportive of the report and its direction, and there will likely be a government announcement soon about how they will begin moving forward to implement the recommendations. MEDEC remains committed to supporting the process forward to ensure that the recommendations are implemented thoroughly and as quickly as possible in order to improve the journey towards a more innovative health care ecosystem.

Source: Page 13 of the OHIC Report

Source: Page 11 of the OHIC Report

In December of last year, the federal government had made some important statements indicating that they were committed to ensuring that reprocessed, single-use medical devices were to be held to the same regulatory standards as the original equipment manufacturers. MEDEC is very pleased that the government has followed through on this commitment and Health Canada will be requiring that all commercially reprocessed single-use medical devices will need to comply with Canada’s Medical Devices Regulations by September 1st, 2016.

In the notice issued on February 5th, Health Canada announced that companies that reprocess and distribute medical devices

originally authorized and labelled for single-use to Canadian healthcare facilities will now be required to “meet requirements for licensing, quality system management, labelling, investigating and handling complaints, maintaining distribution records, conducting recalls, reporting incidents and informing Health Canada of any changes to the information in their licence application.” In order to fulfill labelling requirements, the reprocessor will be required to be listed as the manufacturer of the reprocessed device.

The issue is important because medical devices that are licensed by Health Canada to be used only once or on a single patient during a single procedure are currently

being reprocessed and reused. In 2008, the Canadian Agency for Drugs and Technologies in Health (CADTH) reported that 28% of hospitals in Canada and 42% of hospitals with over 250 beds were reprocessing single-use devices (SUDs) either in-house or by a third-party reprocessor. In 2015, as a result of provincial policies, third-party companies are now doing the vast majority of reprocessing. Until this recent notice, companies reprocessing single-use medical devices had not been required to comply with Canada’s Medical Devices Regulations.

Health Canada will continue to respect the current oversight provided at the provincial and territorial level for reprocessing done on-site by hospitals.

It will be important over the coming months for MEDEC to meet with Health Canada to understand the regulatory requirements and assess the ability of the industry to comply with the expected timelines. In addition, MEDEC will be connecting with provincial government officials as they review and update existing policies and guidelines specific to the reprocessing of single-use medical devices.

This decision by Health Canada is truly a victory for patient safety and will help to maintain the high level of integrity of our industry.Congratulations to the Reuse of Single-Use Devices Task Force for their efforts on this file!

Health Canada to require all commercially reprocessed single-use medical devices to comply with Canada’s Medical Devices Regulations by September 1st, 2016

Regulatory Affairs

Summary

The Collège des médecins du Québec (the CMQ) has made various changes to the Code of ethics of physicians1

(the Code) to address physicians1 independence and impartiality, issues related to new technologies, and respond to requests regarding the accessibility of medical records. Most of the amendments came into effect on January 7, 2015, while others will do so on July 7, 2015.

Extra-billing and financial benefits

Under the amendments, the Code will now deal with the issues of extra-billing and financial benefits in detail. Whereas, at the current time, section 73 of the Code prohibits physicians from “seeking or obtaining undue profit” when they prescribe examinations, medications and treatments,2 beginning on July 7, 2015, physicians will formally be prohibited from obtaining and even seeking such a benefit, either directly, indirectly or through an enterprise belonging to them.3

Also, although “professional fees” do not constitute a prohibited “financial benefit” within the meaning of the Code, physicians will not be allowed to “claim disproportionate amounts” for medications administered or services offered.4 In addition, they will have to provide their patients with an “itemized invoice” evidencing the claimed amounts. The determination of whether the price demanded is “reasonable” will be based on the cost price of the medications (or services offered) and the administrative expenses incurred by the physician.

The prohibition in section 73 will include an exception, however, so that physicians are not, in the CMQ’s words, deterred by this section from participating in research and development activities. Accordingly, section 73(2) of the Code will provide that a physician may make a profit from the sale or marketing of an apparatus or examination that the physician prescribes and has developed (or has contributed to developing), in which case the physician must inform his or her patients.

Moreover, any physician who controls or receives benefits from an enterprise offering therapeutic or diagnostic products (or services) in which the physician has interests

must so inform the circles in which he or she promotes them.5

Finally, physicians will be expressly precluded from (i) selling apparatus or other products unless they administer them directly, (ii) using their title for commercial purposes, or (iii) being party to any agreement or accepting any benefit that could jeopardize their professional independence.6

Accessibility of care and patient’s freedom of choice

The Code as amended now stresses that “a patient [must be] given priority of access to medical care strictly on the basis of criteria founded on medical necessity.”7 Therefore, other factors, including financial criteria, may not be considered. As a result, accepting money for priority treatment or making access to services conditional on payment of a membership fee or annual contribution is formally prohibited.

Furthermore, a patient’s freedom of choice with respect to his or her attending physician is now entrenched in the Code in two additional ways. First, the Code borrows certain prohibitions from the Quebec Charter of human rights and freedoms8 and now expressly forbids any physician from refusing to examine or treat a patient “because of the race, colour, sex, pregnancy, civil status, age, religion, ethnic or national origin, or social conditions of the patient, or for reasons of sexual orientation, morality, political convictions, or language,” or “for reasons related to the nature of a deficiency or illness,” regardless of the context in which such medical condition appeared.9Second, the Code now requires the physician to indicate to the patient, on request, the places where the patient can be treated and to issue a prescription to the patient for that purpose.10 A physician’s freedom to accept or refuse to treat a person, as set out in the Act respecting health services and social services11 (the AHSSS), is therefore tempered by these sections.12

Protection of medical information

To advance the protection of personal information, the obligations of physicians under the Code in the area of professional secrecy have been expanded and adapted in

Quebec amends its Code of

ethics of physicians

By: Olga Farman & Véronique Barry of Norton Rose Fulbright

response to issues raised by the use of email, clouds and social media (including Facebook). For example, the Code now forbids indiscreet conversations on social media by requiring physicians to “refrain from holding or participating, including on social networks, in indiscreet conversations concerning a patient or the services rendered [sic] him or from revealing that a person has called upon his services” and “must take reasonable measures to preserve professional secrecy when the physician uses, or persons working with the physician use, information technologies.” Similarly, to prevent images from being exchanged recklessly over such media, physicians are required to include images and other collated information in the patient’s record.13

Access to and management of medical records

With respect, again, to the protection of personal information, the Code has been amended to bring certain provisions into line with the AHSSS, the Act respecting access to documents held by public bodies and the protection of personal information14 and other laws governing access. Accordingly, the Code now makes it clear that a physician may be required to disclose information concerning a patient without the patient’s consent in the case of an emergency. Such patients may, however, be informed of such communications, which are to be indicated in their record.15 Similarly, physicians now have only 20 calendar days from the time a patient requests access to his or her medical records to respond to the request.16

The Code also introduces measures to favour the communication of patient information to patients, including the stipulation that, when copies of documents are requested by a patient, the physician may not withhold them even if the patient has not paid the fee demanded.17

Conclusion

The Code as revised emphasizes physician transparency, integrity and professionalism and addresses, at least in part, several issues arising from changes in medical practice and evolving new technologies. However, these provisions are raising new questions among certain health sector participants, particularly those practising in private clinics. How the provisions are interpreted will have a major impact on the way medical practice evolves in Quebec.

This article originally appeared in Norton Rose Fulbright’s Pharma in Brief newsletter.

Note from MEDEC: Benoît Larose, MEDEC’s Vice-President, Quebec is currently engaging with the CMQ regarding these changes.

Footnotes

1 CLRQ c M-9, r 17, on line: <http://www.cmq.org/~/media/Files/ReglementsANG/cmqcodedeontoan.pdf>

2 Code of ethics of physicians, CQLR c M-9, r 17, s 73 (O.C. 39-2008, s. 3.)

3 Code of ethics of physicians, CQLR c M-9, r 17, s 73

4 Code of ethics of physicians, CQLR c M-9, r 17, s 76

5 Code of ethics of physicians, CQLR c M-9, r 17, s 79

6 Code of ethics of physicians, CQLR c M-9, r 17, ss 76, 75 and 80

7 Code of ethics of physicians, CQLR c M-9, r 17, s 63

8 Charter of human rights and freedoms, CLRQ c C-12, Art. 10

9 Except for reasons of competence; see ss 5 and 23

10 Code of ethics of physicians, CLRQ c M-9, r 17, s 77

11 CLRQ c S-4.2

12 Act respecting health services and social services, CLRQ c S-4.2, s 6.

13 Guide explicatif – Modifications au Code de déontologie des médecins, January 2015, online:

<http://www.cmq.org/fr/Medias/Profil/Commun/Nouvelles/2015/~/media/Files/ReglementsFR/Code-deontologie-guide-explicatif.pdf?11516>

14 CLRQ c A-2.1 (French only)

15 Code of ethics of physicians, CLRQ c M-9, r 17, s 21

16 Code of ethics of physicians, CLRQ c M-9, r 17, s 94

17 Code of ethics of physicians, CLRQ c M-9, r 17, s 95

Résumé

Le Code de déontologie des médecins1(le Code) détermine, en application du Code des professions2, les devoirs et obligations dont doivent s’acquitter les membres du Collège des médecins du Québec (le CMQ). À cet égard, et en réponse à certains écarts en matière d’indépendance et de désintéressement, aux enjeux posés par les nouvelles technologies et aux demandes en matière d’accessibilité aux dossiers médicaux, le CMQ est venu apporter divers changements au Code, dont la majorité sont entrés en vigueur le 7 janvier dernier, alors que d’autres le seront à compter du 7 juillet prochain.

Surfacturation et avantages financiers

D’abord, le Code traite désormais, en détail, des questions de surfacturation et d’avantages financiers. Ainsi, alors qu’actuellement l’article 73 du Code interdit aux médecins « de rechercher ou d’obtenir indûment un profit » lorsqu’ils prescrivent des examens, médicaments ou traitements3, les médecins seront formellement prohibés, à compter du 7 juillet prochain, d’obtenir et même de rechercher un tel avantage, que celui-ci ne soit obtenu directement, indirectement ou par l’entremise d’une entreprise qui leur appartient4.

Aussi, bien que les « honoraires professionnels » ne constituent pas, au sens du Code, un « avantage financier » prohibé, les médecins seront néanmoins forclos de « réclamer des montants disproportionnés » pour les médicaments administrés ou les services offerts5. Ceux-ci devront de plus remettre « une facture détaillée » à leurs patients, à titre de pièce justificative des montants réclamés. Le caractère « raisonnable » du prix demandé sera, quant à lui, apprécié en fonction du prix coûtant des médicaments (ou services offerts) et des frais d’administration encourus par les médecins.

L’interdiction prévue à l’article 73 comprendra toutefois une exception, et ce, afin d’éviter, comme le souligne le CMQ, que cet article ne décourage les médecins à participer à des activités de recherche et développement. Ainsi, en vertu de l’article 73 (2) du Code, tout médecin pourra retirer un profit de la vente ou de la commercialisation d’un appareil ou d’un examen qu’il prescrit et qu’il a développé (ou pour lequel il a participé au développement) pour autant que ce médecin en informe ses patients.

Par ailleurs, tout médecin contrôlant ou recevant des avantages d’une entreprise offrant des produits (ou services) thérapeutiques ou diagnostiques, dans laquelle il a des intérêts, devra en informer les milieux où il en fait la promotion6.

Enfin, les médecins seront expressément forclos : (i) de

mettre en vente des appareils ou autres produits sauf s’ils les administrent directement; (ii) d’utiliser leur titre à des fins commerciales; ou (iii) d’adhérer à des ententes ou d’accepter des bénéfices susceptibles de compromettre leur indépendance professionnelle7.

Accessibilité aux soins et libre choix du patient

Le Code tel qu’amendé insiste maintenant sur le fait que la « priorité d’accès à des soins médicaux [doit être] donnée à un patient strictement en fonction de critères de nécessité médicale »8 La prise en compte de tout autre critère, dont notamment ceux financiers, est donc interdite. Ainsi, le fait d’accepter des sommes d’argent en contrepartie de traitements prioritaires, ou encore de rendre l’accès aux services de santé conditionnel au paiement de frais d’adhésion ou de cotisation annuelle est formellement interdit.

De plus, le Code consacre, de deux façons additionnelles, la liberté de choix du patient quant à son médecin traitant. D’abord, le Code reprend certaines interdictions prévues à la Charte des droits et libertés de la personne9 et interdit maintenant, de façon expresse, tout médecin de refuser d’examiner ou de traiter un patient « pour des raisons de race, de couleur, de sexe, de grossesse, d’état civil, d’âge, de religion, d’origine ethnique ou nationale ou de condition sociale ou pour des raisons d’orientation sexuelle, de mœurs, de convictions politiques ou de langue », ou encore « pour des raisons reliées à la nature d’une déficience ou d’une maladie », et ce, peu importe le contexte dans lequel cette condition médicale est apparue10. D’autre part, le Code prévoit que le médecin doit sur demande indiquer au patient les endroits où il peut être traité et lui remette une ordonnance à cette fin11. La liberté des médecins d’accepter ou non de traiter un patient, telle que prévue à la Loi sur les services de santé et les services sociaux12 (la LSSSS) est donc modulée par ces articles13.

Protection des renseignements médicaux

En matière de protection des renseignements personnels, le Code est venu étendre et adapter aux nouveaux enjeux soulevés par l’utilisation de courriels, de « clouds » et de médias sociaux (dont Facebook), les obligations des médecins en matière de secret professionnel. Par exemple, le Code interdit toute conversation indiscrète sur les médias sociaux en prévoyant que le médecin doit « s’abstenir de tenir ou de participer, incluant dans des réseaux sociaux, à des conversations indiscrètes au sujet d’un patient ou des services qui lui sont rendus ou de révéler qu’une personne a fait appel à ses services; » et doit « prendre les moyens raisonnables pour que soit préservé le secret professionnel lorsqu’il utilise ou que des personnes qui collaborent avec lui utilisent les technologies de l’information ».

Mise à jour du Code de

déontologie des médecins

auteurs: Olga Farman, Véronique Barry , Norton Rose Fulbright

Pareillement, afin d’éviter que des images et donnés ne soient échangées de façon imprudente sur ces médias, les médecins sont maintenant tenus d’intégrer les images et autres informations colligées au dossier du patient14.

Accès et gestion du dossier médical

En matière de protection des renseignements personnels, le Code a aussi été amendé afin que certaines de ses dispositions s’harmonisent avec celles de la LSSSS, de la Loi sur l’accès aux documents des organismes publics et sur la protection des renseignements personnels15 et de toute autre lois applicable en matière d’accès. À cet effet, le Code précise désormais que le médecin peut être tenu de divulguer, en cas d’urgence ou pour prévenir un acte de violence, des informations concernant ses patients sans leur consentement. Ces patients pourront toutefois être informés de telles communications, celles-ci devant être documentées à leur dossiers16. Pareillement, les délais d’accès aux dossiers médicaux ne sont désormais que de 20 jours calendrier, et ce, à compter de la demande formulée par le patient17.

Le Code met aussi en place des mesures afin de favoriser la communication aux patients d’informations médicales les concernant, en énonçant notamment qu’un médecin ne peut retenir les documents dont copie a été demandée, et ce, même si le patient n’en a pas payé les frais18.

Conclusion

Le Code tel que révisé met l’accent sur la transparence, l’intégrité et le professionnalisme exigé de la part des médecins, et répond, du moins en partie, à plusieurs enjeux soulevés par l’évolution de la pratique médicale et des nouvelles technologies. Il n’en demeure pas moins que ces dispositions soulèvent de nouveaux questionnements chez certains intervenants du domaine de la santé, notamment ceux pratiquant en cliniques privées. L’interprétation qui sera donnée à ces dispositions sera donc décisive quant à l’évolution de la pratique médicale au Québec.

Note de MEDEC : Benoît Larose , vice-président de MEDEC , le Québec est actuellement avec le CMQ au sujet de ces changements .

Notes

1 RLRQ c M-9, r 17, en ligne : < http://www.cmq.org/fr/Medias/Profil/Commun/Nouvelles/2015/~/media/Files/ReglementsFR/Code-de-deontologie.pdf?11516>

2 c C-26. A.87

3 Code de déontologie des médecins, RLRQ c M-9, r 17 art 73 (D. 39-2008, a. 3.)

4 Code de déontologie des médecins, RLRQ c M-9, r 17, art 73

5 Code de déontologie des médecins, RLRQ c M-9, r 17, art. 76

6 Code de déontologie des médecins, RLRQ c M-9, r 17, art. 79

7 Code de déontologie des médecins, RLRQ c M-9, r 17, art. 76, 75 et 80

8 Code de déontologie des médecins, RLRQ c M-9, r 17, art. 63

9 Charte des droits et libertés de la personne, RLRQ c C-12, article 10

10 Sauf pour des raisons de compétence; voir les articles 5 et 23

11 Code de déontologie des médecins, RLRQ c M-9, r 17, art. 77

12 RLRQ c S-4.2

13 Loi sur les services de santé et les services sociaux, RLRQ c S-4.2, art.6.

14 Guide explicative – Modifications au Code de déontologie des médecins, Janvier 2015, en ligne: < http://www.cmq.org/fr/Medias/Profil/Commun/Nouvelles/2015/~/media/Files/ReglementsFR/Code-deontologie-guide-explicatif.pdf?11516>

15 RLRQ c A-2.1

16 Code de déontologie des médecins, RLRQ c M-9, r 17, art.. 21

17 Code de déontologie des médecins, RLRQ c M-9, r 17, art.. 94

18 Code de déontologie des médecins, RLRQ c M-9, r 17, art. 95

The Ontario Medical Association (OMA) recently pulled the plug on their contract negotiations with the provincial government. After almost a year of negotiating, the two parties couldn’t find common ground.

The result? The parties stand at loggerheads, with the Ontario government saying it is committed to moving forward with a plan to manage physician compensation. A plan that physicians say will compromise patient care.

The backdrop to the breakdown in negotiations was the Ontario government’s proposed revisions in doctor compensation, including a 2.65 per cent cut in fee-for-service physician payments, halting premium pay for seeing patients at walk-in clinics on weekends and holidays, and an end to the practice of covering doctors’ continuing medical education fees.

To better understand the dynamics of the battle, here’s the drama explained in five key points.

The playersThe debate around the Ontario government and the province’s doctors summons the old saying “doctor knows best.” But what happens when doctors are on both sides of the negotiating table?

Last year, the Ontario government placed two well-known doctors at the helm of contract negotiations with the OMA. Dr. Eric Hoskins became Ontario’s health minister and

Dr. Bob Bell, former president of University Health Network, became Ontario’s deputy health minister.

Traditionally, premiers have avoided physician-politicians in the health portfolio out of fear that they wouldn’t be able to stand tough against their OMA colleagues. The ultimate resolve of Hoskins and Bell is yet to be determined, but it certainly seems advantageous having two doctors on the government side able to calmly reassure the public that patient care will not

be compromised with the government’s plan.

What the government is sayingSince the deterioration of negotiations, Hoskins has steadily assured the public the government’s plan will not impact service levels or patient care.

The government says doctors are overspending and don’t want to be held accountable to a budget, while noting doctors’ salaries have increased by 61 per cent since the Liberals took power. The government is taking a tough love approach while hoping the public will be unsympathetic to physician complaints in difficult economic times.

What the OMA is sayingThe OMA is positioning the debate as patients versus politics. Its main message is quite simple, the OMA is putting patients first and the government is putting money first. To strengthen its message, the OMA says the government’s offer would have “negative and lasting” impacts on patients.

The OMA argues doctors already took a four per cent cut during its 2012 negotiations and were willing to take a freeze but not a cut this time around.

The conciliator The two parties brought in Ontario’s former chief justice, Warren Winkler, to serve as a conciliator for their negotiations. The government leaned heavily on his eventual counsel that the OMA should take the government’s offer. He is quoted as having said the deal is ““good for Ontarians, good for the health-care system and fair to doctors.”

Winkler also recommended creating a task force on the future of medical services provided by doctors as well as a minister’s roundtable on the transformation of Ontario’s health system.

Ontario doctors vs. the Ontario government:

diagnosing the challenges of negotiation

by Mike Van Soelen, President of Playbook Communications

Hon. Dr. Eric Hoskins, Minister of Health and Long-Term Care

Dr. Ved Tandan, OMA President

#CareNotCuts

After stepping away from the negotiations, the OMA launched a hard-hitting grassroots campaign, known as

#CareNotCuts. The OMA came out in full force with an aggressive website, social media activity and radio, print and

TV advertisements.

The campaign emphasizes a divide between the government and doctors by calling on the province to put patients

before politics. To strengthen its efforts, the OMA’s website includes an automated feature allowing people to send a

letter to their MPPs. The OMA hopes the letters will start filling the inboxes of government MPPs and demonstrate the

public is on their side.

In conclusion

With two parties so strongly divided, those watching the situation are left to wonder what’s next. Ontario doctors can’t

strike and won’t be cutting the hours they work. The government has a strong majority and seems determined to move

ahead with its plan to manage physician compensation.

The question of who comes out ahead is likely answered by this question: whose message will ring most true with the

public? For a read on who’s ahead, just speak to everyday people in your social circles. The side that is winning over

their loyalties is likely the side that will ultimately persevere.

“The backdrop to the breakdown in negotiations was

the Ontario government’s proposed revisions in doctor compensation, including a 2.65 per cent cut in fee-

for-service physician payments, halting premium pay for seeing patients at walk-in clinics on weekends

and holidays, and an end to the practice of covering doctors’ continuing medical education fees.”

Recent HighlightsMEDEC’s Federal Affairs and HTA Committees meet with federal government representatives

In December, MEDEC’s Federal Affairs Com-mittee and Health Technology Assessment Committee held highly successful engage-ment days in Ottawa. The committees held a joint meeting with Jean Pruneau and Nicole Charron of Health Canada, took part in a roundtable with Industry Canada, met with a Senior Policy Advisor in Liberal leader Justin Trudeau’s office and met with CADTH to learn about the HTA work that the agency is doing on devices.

Thanks very much to MEDEC Allied Business Member FleishmanHillard for hosting the joint committee meeting.

Representatives from the MEDEC Federal Affairs and HTA Committees holding a joint committee meeting at FleishmanHillard’s Ottawa offices.

MEDEC Advocacy Day on Parliament Hill in Quebec City

Late last year, delegates from 12 MEDEC companies across the scope of the association’s diverse membership met with representatives of the political cabinet of 5 ministries from the Quebec govern-ment including Ministry of Health and Social Services, Ministry of Economy, Innovation and Exporta-tion, Ministry of Higher Education and Research, Treasury Board and Ministry of SMEs and Regional Development. The group also met with the Parti Québécois and Parti Libéral caucus.

This meeting blitz was a first for MEDEC in Quebec City and aimed to make a statement about our as-sociation and industry to highlight the importance of the sector in the economy and MEDEC’s role as a partner of the province’s healthcare system. The Value of Technology strategic pillar was the main theme of meetings along with our well known issues with sub-optimal procurement strategies that are negatively affecting the healthcare environment.

The MEDEC delegation was very well received and it is expected that this initiative will pave the way for increased and more focused actions with political stakeholders going forward.

The 2015 Mercer Life Sciences Compensation Survey – Medical Devices Report (MEDEC) is your complete resource for compensation data.

MEDEC and Mercer (Canada) partner to deliver the Mercer Life Sciences (MLS) Compensation Survey as a valuable resource providing companies with need-to-know information about compensation practices in the medical device industry.

The survey covers a broad selection of benchmark positions relevant to the medical devices industry ranging across pre-clinical and clinical research, engineering, medical affairs, sales, marketing, production and administration, as well as the full range of general infrastructure/support functions.

This survey is accepting data submissions from February 11 through April 17. You are invited to download the 2015 participation materials at imercer.ca/camls. Former MEDEC survey participants will receive an email from Mercer with a pre-populated questionnaire, making the year-over-year submission process even easier.

Join us on March 12 for an overview of the participation process including highlights of MLS, job matching, data submission, and input verification specifically for MEDEC members. Register now for this training webcast at imercer.ca/events.

MEDEC Survey Highlights:

Exclusive data only available to participants.

The 2014 Mercer Life Sciences - Medical Devices Report (MEDEC) includes over 5,000 incumbents representing 37 participating organizations.

Extensive job catalogue that aligns with your organization structure.

Surveys over 400 industry specific jobs alongside over 500 general industry jobs.

Fully customized analysis using Mercer WIN.

Compare positions year over year; analyze base salary, incentives, and total direct compensation by revenue, geographic location, peer group, and more.

The ability to look at sales data in a more refined

manner.

Sales jobs defined by both sales channel and product

line (capital equipment, durable goods, consumables/

disposables, and implantable devices) for additional

insight and analytics.

Multiple purchase options.

Buy only medical devices data or data from across life

sciences (medical devices, pharmaceutical, biotechnology,

and related areas).

Exclusive offer for MEDEC members:

A $500 discount when MLS purchase is bundled with

Mercer MBD or EMP general industry surveys.

FREE access to Mercer Compensation Policies and

Practices Survey - Standard Report, upon participating

in the biennial survey.

Visit imercer.ca/camls for full survey details including, data

fields collected, benchmark position coverage, data analysis

options, current participant list, survey pricing and schedule.

The survey results will be released in late September, and are only

available to participants, so don’t miss your opportunity to be part

of the 2015 Mercer Life Sciences Survey. If you have questions

regarding the survey or the participation materials, please call a

Mercer Representative at 800 333 3070.

Patent NewsBy Serge Lapointe, Fasken Martineau

Rightly, companies rely increasingly on innovation to ensure their success on a global scale. To remain competitive in both domestic and in-ternational markets, it is essential for companies to be aware of the new technologies, particularly those protected by third party patents. The following table is intended to present recent examples of granted patents or published patent applications in a particular field related to medical devices.

RECENT ISSUED PATENTS OR PUBLISHED PATENT APPLICATIONS IN PORTABLE MEDICAL DEVICES

PATENT NUMBER

DESCRIPTION ASSIGNEE(S) INVENTOR(S) PRIORITY APPLICATION DATE

PUBLICATION DATE

US2015011894 SYSTEM FOR AND METHOD OF QUANTIFYING ON-BODY PALPITATION FOR IMPROVED MEDICAL DIAGNOSIS.

A haptic sensor for performing palpation includes a deformable membrane having a reflective surface, a light source, a camera, and a processor. When the sensor is pressed against an object on a body, the deformable membrane deforms to contour to the shape of the object, light is reflected off the reflective surface, and captured by a camera. The reflected light is processed to reconstruct a 3-D image of the object. The rendered image can show abnormalities such as cysts, tumors, or other abnormalities, as well as arterial pressure pulses. In different embodiments, the sensor illuminates the deformed membrane from multiple directions, using shape-from-shading or grayscale mapping, or using video streams to provide more accurate images. The sensor is able to be included as part of a mobile device, such as a mobile phone, thereby making it compact and portable.

Univ. of Cali-fornia

Rofouei M.;

Sarrafzadeh M.;

Sinclair M.

19/12/2011 08/01/2015

WO15002276 COMPACT MEDICAL X-RAY IMAGING APPARATUS.

An X-ray imaging apparatus which is portable, and with which it is possible to capture clear X-ray images while maintaining low radia-tion exposure.

Tsukuba Technology Co Ltd ;

National Institute of Advanced Industrial Science and Technology

Matsuoka K.;

Saito N.;

Wang B. ;

Wang X.;

Suzuki R.

03/07/2013 08/01/2015

US2015010441 ELECTRONIC PREGNANCY TEST DEVICE. A handheld, readily portable, electronic pregnancy test device including a CPU in oper-ational communication with a human Chorionic Gonadotropin (hCG) hormone sensor able to detect a level of hCG in a blood sample dis-posed upon a test strip. The strip is loaded into the device through a test strip portal. The pregnancy is verifiable and hCG doubling times are immediately calculable whereby the health of the pregnancy is determinable absent direct medical assistance.

Kahn E. M. 02/07/2013 08/01/2015

WO15002945 ALGORITHMS FOR MANAGING ARTIFACT AND DETECTING CARDIAC EVENTS USING A PATIENT MONITORING SYSTEM. Provided are devices and methods for monitoring patient health pa-rameters using a wearable monitoring device. It includes algorithms for artifact rejection and for detection of cardiac events using a remote health parameter monitoring system.

Mayo Founda-tion for Medical Education and Research

Bennet K. E.;

Bruce C. J.;

Somers V. K;

Friedman P.A;

01/07/2013 08/01/2015

US2015009473 IMAGING AND LIGHTING OPTICS OF A CONTACT EYE CAM-ERA. The optical design for a contact type portable eye imaging apparatus, including the imaging optics and illumination optics are proposed, which utilizes miniature image sensor and solid state light emitting technology, as the next generation of medical imaging devices, in particular in ophthalmic imaging applications.

Visunex Med-ical Systems Co

Su W.; 17/03/2012 08/01/2015

Serge Lapointe is a Partner and Patent Agent at Fasken Martineau’s Montreal office. Please feel free to contact Serge for obtaining copies of any of these documents or should you have any questions on this particular topic or on intellectual property in general. He can be reached at slapointe@fasken.com.

DRAFT CONFERENCE OUTLINE:Wednesday, April 29, 2015Confirmed Speakers include: Dr. Joshua Tepper, CEO, Health Quality Ontario

Dr. Cy Frank, CEO, Alberta Innovates - Health Solutions

Dr. Tom Noseworthy, Associate Chief Medical Officer, Strategic Clinical Networks and Clinical Care Pathways, Alberta Health Services

Anil Arora, Assistant Deputy Minister, Health Products & Food Branch

David K. Lee, Director, Legislative & Regulatory Modernization, Health Canada

Thursday, April 30, 2015Confirmed Speakers include:Dr. Bob Bell, Deputy Minister of Health, Ontario Dr. Teodor Grantcharov, Surgeon, St.Michael’s HospitalMichael Stewart, Ontario Ministry of Health & Long-Term Care

Concurrent Sessions both days -- Commercial stream and Regulatory Affairs stream.

MEDEC405 The West Mall, Suite 900, Toronto, Ontario M9C 5J1T: 416-620-1915 F: 416-620-1595Toll-free: 1-866-58-MEDEC(632332)E: medec@medec.org www.medec.org

Preliminary Draft AgendaAvailable online at: www.medec.org/content/medec-2015-medtech-conference

Who Should Attend?Presidents, General Managers, Country Managers, Goverment Relations Directors / Man-agers, Regulatory Affairs Associates, Sales / Marketing Associates, Business Development Associates, Commercial Account Associates, Health Strategy / Health System Associates

Government officials, Healthcare providers (LHINs, CCACs, Hospitals, home care, long-term care), Clinicians, Group Purchasing/Shared Services Organizations, and other healthcare partners and stakeholders

Hotel InformationA small block of rooms has been reserved at the Sheraton Toronto Airport Hotel & Confer-ence Centre. Our group rate is $169.CAD (single/double occupancy). The deadline to make your hotel reservation is March 30, 2015. The hotel rate is subject to applicable city, country or provincial taxes/fees that apply at the time of room occupancy. Check in time is 3:00 pm /check out time is 12 noon.To make your reservation call: 1.866.932.7058 and state that you are with MEDEC - MedTech Annual Conference to receive the special group rate.Please note the hotel charges $2.50 per hour for parking to a maximum of $15 per day.

TIME: Wednesday, April 29 - 8:00 am to 5:00 pm Thursday, April 30 - 8:00 am to 5:00 pm

REGISTRATION: NOW OPEN!Early Bird (Feb 1 to Mar 31/15)

Regular(Apr 1 to 30/15)

Member One Day $649 $699

Member Two Day $849 $899

Non-Member One Day $849 $899

Non-Member Two Day $1049 $1099

Government/Healthcare Org - One Day $99 $99

Government/Healthcare Org - Two Day $159 $159

Registration includes: conference, breakfast, breaks, lunch and networking reception April 29

GROUP RATES AVAILABLE! Contact Natasha Alves, MEDEC, nalves@medec.org or 416.641.2746

LOCATION: Sheraton Toronto Airport Hotel & Conference Centre 801 Dixon Road Toronto, Ontario M9W 1J3 Canada Phone: (416) 675-6100

Wednesday, April 29, 2015Thursday, April 30, 2015

2015 MEDECMEDTECH CONFERENCE

April 29 and 30, 2015

JOIN US!

TRANSFORMATION THROUGH INNOVATION

LEARN. SHARE. ENGAGE.