Life Science Compliance Update

October 10, 2017

Belgian Sunshine Act Decrees Issued, Providing Guidance


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 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, 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



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.




August 14, 2017

Sunshine Act Takes Effect in South Korea


In early 2017, South Korea joined the global transparency movement and enacted a “Sunshine Act” similar to others found around the world. The law requires pharmaceutical and medical device companies operating in South Korea to prepare an aggregated expenditure report if they have provided economic benefits to healthcare professionals and others employed at medical institutions during a fiscal year.

Interestingly, while the scope of the Korean Sunshine Act is broader than the United States law, it does not require companies to submit the aggregated report and any supporting documents to the government unless it is determined to be necessary by the Minister of the Ministry of Health and Welfare of Korea. Therefore, it follows that the collected data will not be made public.

The covered recipients for Korean Sunshine Act can be categorized into four groups: (1) pharmacists; (2) herbalists (including persons working for the relevant pharmacy); (3) “medical personnel”, which includes physicians, dentists, acupuncturists, midwives, nurses); and (4) medical institution founders (including the representative, director and other employees of a juristic person) or persons working for the relevant medical institution for the purpose of sales promotion, such as adoption of drugs or inducement of prescription.

Types of reportable economic benefits include:

  • Product samples;
  • Academic conference sponsorships;
  • Honorarium provided to a covered recipient for conducting post-marketing surveillance (PMS) (equivalent to phase 4 clinical trials in US);
  • Funding of clinical trials;
  • Food and beverages and other “freebies” (such as pens, notepads, etc.) provided at the product presentations; and
  • Discounts on drug or medical device sales made with certain payment methods.

The Ministry released seven templates for the Report for all reporting categories:

  • Provision of samples – including institution, product information, and date of provision;
  • Sponsorship to academic conferences – including conference info and support funds amount;
  • Support for clinical trials – including trial information, contact, joint investigator’s info, and support details (TOV amount, number/volume of product supported, contracting date);
  • Product presentations
  • Presentations held formultiple medical institutions: product info, HCP name and medical institution, TOV amount including travel, lodging, food and beverages, and other “souvenirs” or giveaways (e.g. pens, notepads, etc.)
  • Presentations held at a single medical institution: product info, medical institution info, HCP name, TOV amount (food and beverages) and date;
  • Post-market surveillances (PMS) – including product info, HCP info, and support details; and
  • Price discounts based on payment conditions – including medical institution info, contracting date, and discount rate

For the product presentations, the reporting threshold for food and beverages, as well as other “souvenirs” or giveaways is 10,000 won (roughly $9). For all other types of transfers of values, there is no minimum threshold amount triggering the reporting obligation, and they should all be recorded in the applicable reporting template.

The reports must be kept for five years, along with supporting documentation. Companies are required to start collecting expenditure information on January 31, 2018. The report and supporting documentation must then be prepared within three months following the end of the company’s 2018 fiscal year. For example, if Company A’s 2018 fiscal year ends December 2018, then the report must be prepared by March 2019. If Company B’s 2018 fiscal year ends in March 2019, then the report must be prepared by June 2019.

A reporting template was issued in June 2017, and can be found here. Life sciences companies operating in South Korea will need to create a clear and efficient process and system to ensure they meet these difficult reporting requirements.

Special thanks to Polaris a Quintiles-IMS Company for the tip and the analysis. and the Korean Ministry of Health and Welfare





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