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April 25, 2018,   9:46 AM

Medical Manufacturers Step Up To Tighter Compliance

Claudine Coletti


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The power held by pharmaceutical and medical device companies is ever-increasing as they deliver the products to save and prolong people’s lives. In the last five years global regulations have tightened to make sure that these companies are operating transparently for those that rely on them most—patients. The Middle East is now following suit.

The business behind the promotion of pharmaceuticals and medical technology is as highly-scrutinized as it is impactful, and as such subject to increasingly tighter rules and regulation across the world to ensure that the sway companies have over medical professionals is kept unbiased and transparent.

Financial relationships between healthcare professionals and product (such as drug or MedTech) manufacturers have always been commonplace. For example, doctors and physicians often travel internationally for medical conferences and congresses to learn about the latest innovations and how to use them, or indeed speak at industry events. In the past it was possible for medical product manufacturing companies to sponsor individuals and organizations and pay towards such trips without complete disclosure. Payments and sponsorship could include funding education or paying for professional services—it could also include covering travel costs and expenses and paying for meals in the workplace. A lack of complete transparency led to the question of potential conflicts of interest, and whether these relationships may have a direct or indirect influence over how professionals promote or use their products.

That is now changing. Since 2013, medical product manufacturers in the U.S. have been required to disclose all payments or other “transfers of value” made to healthcare professionals and organizations under the Physician Payments Sunshine Act, as well requiring some manufacturers and group purchasing organizations to disclose any ownerships or investment interests that physicians may have in their companies. Europe soon followed suit in 2016, with the European Federation of Pharmaceutical Industries and Associations Disclosure Code requiring its members to document and disclose transfers of value. The data collected is published and made publicly available. Although in Europe healthcare professionals are required to give their permission to publish payment information, where consent is not given details are published in aggregate, with companies disclosing the number of professionals that withheld consent and the total amount paid to them.

The Middle East has paid attention to the global trend and is considering how to improve standards within its own booming healthcare sector. “The GCC pharmaceutical sector is growing. Saudi Arabia and the U.A.E. continue to be the largest markets for sales,” says Enrique Manzoni, Regional Managing Director for the Middle East, Turkey and Africa at Boehringer Ingelheim GmbH. “The U.A.E. market alone will surge to over $28 billion in 2021. There is considerable focus in the region on corporate responsibility that goes beyond financial gains, one that works towards collectively raising the bar in terms of infrastructure, medication availability and skills development.”

Now the region is creating its own transparency laws, with new legislation for pharmaceutical companies released by KSA’s Saudi Food and Drug Authority (SFDA) in February 2018—the Pharmaceutical Company Payments Disclosure Initiative—promoting disclosure in line with international standards. Other MENA countries, including the U.A.E., are believed to be exploring similar routes.

Under the SFDA’s new initiative, medical companies must report all financial support including (but not limited to) consulting fees, speaking fees, training fees, the sponsorship of healthcare professionals to attend an educational event, research or educational grants, symposium or conference sponsorships, hospitality, gifts or entertainment and the supply of scientific materials such as books or instruments.

Some companies in the region are well prepared for the change. MENA’s trade association for medical technology and pharmaceutical companies, Mecomed, came into being back in 2007 made up of just four companies—today it covers 21 countries and around 600 million people through its 36 members. In October 2017, Mecomed released a new updated code of ethics for its members in line with European guidelines. Coming into effect on January 1, 2018, the guidelines are designed to strengthen trust in the industry and reduce the number of patients that choose to travel abroad for treatment.

“We are in a much better position than others because we have our code and we have already started,” says Mecomed chairman, Rami Rajab. “A company cannot go to a doctor and tell the doctor or lab technician or HCPs (healthcare professionals), we are inviting you for a conference and covering all your expenses. In future such invitations should go through the authorities or made through the organizers of the meeting, but you cannot have a direct invitation to the doctor that could lead to an influence on behavior.”

While the positive effects of such regulation are beneficial for both the transparency of the industry, and ultimately the care of the patients, there may be a transition as companies find new ways to share best practice and new products with professionals that are cost effective and within the boundaries of the new guidelines. Rajab believes many are already on the case.

“Most companies have developed regional education programmes where they will train doctors on the newest technology and innovation as companies, not going through conferences,” Rajab explains. “We are keen on education, and the transfer of technology to healthcare professionals, and we are doing it in a different way rather than direct sponsorship. If you send one doctor or one healthcare professional to the U.S. or to Europe to get training on a certain technology you can send one or two. However, if you can organize regional training in situ then you can bring 20 doctors.”

Digital tools are also helping companies to link up with and teach professionals about new products without the need for travel. “Technology is a key enabler, creating a network of professionals who are able to connect more easily,” agrees Manzoni. “We organize conferences across the region, and throughout the world, with the aim of educating healthcare providers and through them patients to explore the various treatment options to best match patient needs. These events are maximized through live links and digital platforms, where we are able to reach even more physicians in different countries, which is both time and cost effective.”

While manufacturers explore new methods of sharing knowledge and figure out how that may change their working relationships, with tighter rules and requirements demanding transparency in the industry patients should feel more secure that going forward their best interests are being put first. As medical companies prepare to disclose to Saudi for the first time, the rest of MENA is unlikely to be far behind.

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