Life Science Compliance Update

October 11, 2017

MedTech Europe Changes Ethical Code

Playbytherules

MedTech Europe represents the medical technology industries as a joint venture between EDMA and Eucomed and promotes a balanced policy environment that helps the medical technology industry meet Europe’s growing healthcare needs and expectations.

In 2015, MedTech Europe implemented a revised version of the 2008 Code of Ethical Business Practice to regulate interactions between members of the group and healthcare professionals. To help implement the code, in 2012, MedTech Europe created the Conference Vetting System. The Conference Vetting System attempted to address MedTech Europe members’ divergent interpretation of the Code and to reduce the risks associated to industry sponsorship of healthcare providers to third-party educational events.

The new MedTech Europe Code of Ethical Business Practice sets strict, clear and transparent rules for the industry’s relationship with Healthcare professionals (HCPs) and Healthcare Organizations (HCOs), including company-organized events, arrangements with consultants, research and financial support to medical education.

The Code of Ethical Business Practice has six big changes: (1) the phasing out of direct sponsorships; (2) transparency of educational grants; (3) creating a common chapter on general criteria for events; (4) creating a new chapter on demonstration products and samples; (5) agreed definitions; and (6) a common independent enforcement mechanism.

According to MedTech Europe, the new Code is a message from the medical technology industry to safeguard and protect the relationship with healthcare professionals by adopting clear and strict self-regulations.

The largest change coming from the new educational grant system is that it adds a significant amount of work onto the shoulders of the healthcare organization.

  1. Conferences supported by medical device companies will need to apply and be in compliance with the Ethical Vetting System;
  2. Healthcare organizations will need to write and submit grant requests to each medical device company that sponsors delegations to their medical meeting;
  3. Once awarded the grant, healthcare organizations will be responsible for choosing the healthcare providers that will receive support, following the guidelines as set forth on the grant requested;
  4. Healthcare organizations will be responsible for the management of the sponsored healthcare providers, including figuring out how to contact them, gather their information, manage their travel requirements, etc.; and
  5. Healthcare organizations and medical device companies will need to submit reconciliation and disclosure reports to MedTech Europe.

The rules will change in several ways, including: by forcing the public disclosure of grants, ensuring increased transparency of the funds allocated to medical education; by requiring conferences to comply with specific requirements and the Conference Vetting System; by allowing grants to be provided only to legal entities and never individuals, requiring a written contract and other related documentation; by allowing companies to define the types of recipients eligible for the grants; and by requiring companies to have internal and independent processes based on objective criteria to assess grant requests.

While most of the changes will affect European meetings, the most important change for the United States medical meeting industry is that MedTech Europe member companies will not be able to directly sponsor a healthcare provider, neither as a delegate nor as a speaker.

As of 2018, MedTech Europe will require all meetings to be vetted through its Conference Vetting System, and only these meetings will be eligible to receive funds from MedTech Europe member companies — and only through educational grants.

Healthcare organizations should brace themselves for an impact and will need to plan for a loss in revenue from any international delegations sponsored by Medical Technology Companies in Europe.

October 10, 2017

Belgian Sunshine Act Decrees Issued, Providing Guidance

Belgiumparliament

On June 23, 2017, the Belgian “Sunshine Act” became law, requiring life science companies to disclose relationships with healthcare actors in the country. The Decree confirmed that the first publication of data under the statutory transparency regime will cover transfers of value for the year 2017 and will be published on betransparent.be by June 30, 2018.

The June 23 Decree notes that the provisions of the Sunshine Act apply to “premiums and benefits granted during calendar year 2017 to healthcare professionals, healthcare organizations and/or patient organizations.”

A second Decree was issued on August 22, 2017, which designated the ethical health platform Mdeon as the organization that will handle the practical aspects of disclosure on behalf of the Federal Agency for Medicines and Health Products (FAMHP). Mdeon will be managing theh publicly accessible website that will disclose the premiums and benefits that pharmaceutical and medical device companies grant to healthcare professionals and organizations, as well as patient organizations, annually.

It is unclear whether this determination causes the Sunshine Act to have retroactive effect in that it would require firms to notify and publish the transfers of value that occurred during all of 2017.

There are, however, certain benefits and premiums granted to these beneficiaries that do not have to be notified. These exceptions are (i) premiums and benefits of limited value that concern the practice of medicine, dentistry, pharmacy or veterinary medicine; (ii) meals and drinks supplied during scientific events; (iii) premiums and benefits that are part of ordinary-course purchases and sales of medicinal products or medical devices by and between a pharmaceutical or medical devices company and the beneficiary; and (iv) samples of medicines.

Before the implementation of the Sunshine Act, only industrial codes of conduct were adopted in order to enhance the transparency of transfers of value from pharmaceutical and medical devices companies to HCPs and HCIs. The transparency obligations were only mandatory for companies that were members of an association that had a code of conduct in place. 

The transparency obligations are now mandatory for all companies under the Sunshine Act. Considering the scope of the definition of “notifiers”, this practically covers all companies in the healthcare sector. Therefore, the scope of the notification obligation is very broad.

Sometime in September 2017, betransparent.be plans to organize an information session for the industry to explain – in detail – the new legal framework, including the differences with the current transparency in self-regulation.

September 19, 2017

Study Released on Comparison of International Regulatory Authorities

International

 

Pharmaceutical regulations vary widely across the world, and while our sister publication, Life Science Compliance Update, keeps compliance professionals abreast of new development and comparisons across continents and countries, an article published August 2017 in Nature Reviews Drug Discovery offers comparisons in terms of the regulators’ budgets, staff, new drug approvals and timelines for approvals.

 

Of the regulators in the more established major pharmaceutical markets (in this study, the United States, Europe and Japan are considered the regulators in such markets), the United States Food and Drug Administration (FDA) has the most internal reviewers (an estimated 2,000), though the European Medicines Agency (EMA) has a network of more than 4,500 experts providing scientific expertise to the agency.

 

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), meanwhile, has about 560 reviewers, while the China Food and Drug Administration (CFDA) had only about 120 staff in its Center of Drug Evaluation to perform scientific evaluations through August 2015. Since August 2015, the research says the State Council of China has brought that number up to about 300 to work through a backlog of applications. 

 

As far as new drug application (NDA) submissions and approvals, differing NDA definitions or their equivalents between authorities make direct comparisons difficult, though in the established markets, the FDA was noted as approving the most NDAs for new drugs (45) in 2015, while Japan’s PMDA approved the most NDAs (48) in 2016. 

 

Similarly, timelines to NDA approval have different definitions and processes, though the researchers said the shortest time to market was 210 calendar days for EMA and the longest was 900 calendar days for CFDA (though CFDA is trying to accelerate that process). Several of the authorities also have programs to enable accelerated review of products that are considered to be addressing particularly important medical needs, such as the FDA's priority review designation, which is associated with a review timeline of 180 days, compared with the standard review timeline of 300 days.

 

NDA review fees also vary, the authors reported, noting India had the lowest fees (50,000 Indian rupees; ~$1,000), whereas FDA had the highest ($2.3 million). 

 

"Overall, the regulatory authorities in developed countries such as the United States, European Union, UK, Canada and Japan are more evolved in terms of regulatory systems and resources, such as technical reviewers, but have higher NDA fees," the authors wrote.

 

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