BMI SYSTEM attended the Global Transparency Reporting Congress in London as a speaker and sponsor.

A lot of issues around the first EFPIA disclosure of Transfer of values were discussed:
• How to manage consent and data privacy
• EFPIA requirements and local regulations
• The impact of the disclosure on HCPs relationships with the pharmaceutical industry
• The need to clean and standardise data before the disclosure

ABPI Disclosure Summary

The Association of the British Pharmaceutical Industry (ABPI) has incorporated EFPIA Disclosure Code requirements into its own Code of Practice.
Any transfer of value between a pharmaceutical company and a healthcare professional or an organisation must conform to the ABPI Code of Practice and be disclosed publicly on the dedicated ABPI website.

Over the last couple of years, the industry aggregate payments were £40m in 2012 and £38.5m in 2013, covering 20,000 relationships (not individuals). This aggregate disclosure is an interim step toward individual HCP disclosure, which is coming into effect in 2016 for payments made in 2015.

On the 1st of July, companies will have to disclose two documents: the transfer of value data following the ABPI template and a methodological note.

The transfer of value (ToV) template will show the following data:
• ToV to individual HCOs
• ToV to consensual individual HCPs
• Aggregate ToV for non-consensual HCPs
• Aggregate ToV related to R&D

In case of queries, data will be transferred to the aggregate section of this template until their resolution.

In order to make sure data is accurate and up-to-date, the process will spread over a few months.

Below are the main steps:

ABPI process

There is a general concern in the pharmaceutical industry about HCPs reception toward public disclosure and how it will affect industry relationship with HCPs. According to the ABPI 2013 survey of over 1,000 HCPs, 79% of HCPs are in favour of public disclosure and 77% in favour with individual public disclosure.

In comparison, we can take the U.S. counterparts (Sunshine act) data: 5 months after go live, 72% of HCPs were aware of the existence of the disclosure database, among them 79% from media. Also only 46% of them had logged onto the website while 85% said they would do so prior to the go live. Half of them have checked their own data. The main reason for not logging in was “do not care”.

Regarding the disclosure effects on industry relationships with HCPs, 76% of HCPs working with the pharmaceutical industry declare that disclosure would either have no effect on their collaboration, or would make them more likely to collaborate in the future (ABPI 2013 survey). 14% of HCPs said they will be less likely to work with the industry. In the U.S., 76% of physicians said that disclosure had not affected their participation in industry activities whereas 21% said their involvement had decreased and 3% reported an increased engagement with the industry.

Managing Disclosure Consent and Data Privacy

The EFPIA Disclosure Code states that the “EFPIA recognises that disclosure can raise data privacy concerns“.  The draft notes in Clause 21 of the Code states that “Companies are encouraged to include in a contract involving a transfer of value provision regarding the consent of the recipient to its disclosure.  In addition, companies are encouraged to renegotiate existing contracts at their earliest convenience to include such consent to disclose.”

Data Privacy: Collect and Protect

One of the biggest challenges for disclosure is data accuracy. Indeed pharma companies must respect HCP individual data and protect it according to European law.

HCP data such as name, email and affiliation is personal data and thereby qualifies as protected in a number of countries. According to the speakers, King & Spalding, “This complicates the approach for complying with data privacy laws while publishing HCP/HCO payments and transfer of value in an effort to achieve transparency”.

As European laws regarding data privacy differ from one country to another it is an additional challenge. Learn more about personal data protection and compliance with the European Code for Pharmaceutical Industries.

Crossborder operations raise concerns for international data transfers. Data accessibility from outside Europe over a computer network should only be possible in countries providing an adequate level of protection.

Disclosure Consent

It is important to understand what data is being collected. Companies have to let HCPs know how and why are they collecting, keeping, disclosing and processing their data and for how long – data is published for 3 years and retained for 5 years. Good communication will help to gather accurate data as well as the HCP individual consent for individual disclosure. It will reduce the risk of withdrawal and dispute.

It is the HCPs’ responsibility to notify of any changes in personal data.
A better transparency for payments and other benefits is aimed at enhancing HCP/HCO relationships. Consent is generally required for data collection and processing. As other HCP data, consent must be obtained, recorded, tracked and kept. Depending on each country’s specific regulations it may be refused, revoked, or not required.

Data: Accurate, Unique and Up-to-Date

Lexis Nexis raises another issue: complexity emerges when one takes into consideration that each company can have multiple systems for data sources. Also, the same data is stocked in various format, languages etc. All data is not as unique and reliable as it should be. It is essential to collect and process ‘clean data’. A strategy that yields improved accuracy is the standardisation of data.

Of course data treatment is not at the core of the pharmaceutical industry, but “By 2017, 33% of global companies will experience an information crisis due to their inability to value, govern and trust their enterprise information” (Gartner 2015).

To avoid such a crisis the industry is going toward a generalisation of external data management.

The adoption of a global transparency solution such as NAYA, BMI SYSTEM’s solution with centralised rulesets that respect local specificities addresses both the standardisation and uniqueness issues as data is consolidated in a single system.
To find out more, please click here.