During the last event jointly organized by BMI SYSTEM and LCH Avocats, Laurent Clerc, from BMI SYSTEM, presented an analysis of the 1st EFPIA disclosure for five countries.
Focus on Five Countries
Several EFPIA member countries for which disclosure information was readily available were discussed throughout the morning.
It is important to note that the information presented below was collected in November 2016 and may have evolved since that time.
It should also be noted that the perimeter of the laboratories concerned may differ from one EFPIA member country to another (some countries include OTC or generics, others do not). This point should therefore be taken into consideration before any comparative analysis can be made.
In Germany, 75 EFPIA companies published € 575 million in transfers of value to HCPs and HCOs on their respective websites. R&D expenditures represented 58% of this amount. Outside of R&D, transfers to individuals amounted to € 119 million and transfers to institutions amounted to € 90 million.
In Belgium, € 138 million in transfers of value were disclosed on the MDEON site by 80 registrants. 65% of these relate to R&D activity, 13% to grants and donations, 17.5% to hospitality and only 5% to fees. It should be noted that a recent law has made disclosure mandatory for all health industries (pharmaceutical, veterinary and medical device).
190 laboratories released data on their websites in Spain for a total of € 496 million. R&D accounted for 38% of this amount, with 18% attributed to fees, 13% to hospitality and 13% to donations.
With 43 declarations on a single site, Ireland disclosed €28 million in transfers of value, including 37% for R&D, 30% for hospitality, 9% for fees, and 25% for donations.
In the United Kingdom, 107 companies made declarations on a unique public site, with the total amount attaining £ 363 million. 70% of this was for R&D, with only 12% for fees, 9% for hospitalities and 1% for “Joint working” events (joint events between a laboratory and the NHS).
In conclusion, although the amount of value transfers is logically closely correlated to the size of the country, there are clear differences in the distribution of the amounts, notably between hospitality and fees. In some countries, for example, transfers of value represent hospitalities rather than fees (Ireland or Belgium for example). Similarly, in some countries (Germany and the United Kingdom) the share of R&D is very high.
For the time being, these results are only for one year. It will be interesting to check whether these trends are confirmed during the second disclosure in June 2017.
The disclosure requirements are quite different from those defined by the EFPIA:
- The perimeter of manufacturers to be declared is broader
- The types of recipients are more numerous (HCOs in particular)
- The amount for fees is not yet disclosed
Also, the disclosure structure differs from that imposed by the EFPIA. In France, disclosure is done by benefit, and not by recipient.
The analyzes presented below concern the data published in January 2017 on the official French site.
There is a large increase in the benefits published from 2012 to 2013, followed by a plateau in 2014 and 2015, with a slight decline in 2016. The disclosed benefits amount to € 255 million.
It is very difficult to compare with other EFPIA countries since, as indicated above, the amount of the agreements is excluded (the French amount is globally comparable to the EFPIA level, hospitality plus the amount for donations and grants).
- Benefits Analysis
The share of benefits representing € 10 is 0.1% of the total amount (in value) of the benefits. The share between € 10and € 100 represents 30% of the total, and that between € 100 and € 1000 approaches 40%. Looking at the evolution of this distribution over time, it can be seen that the amount of benefits between € 10and € 1000 is generally always the same. It should be noted that 70% of the disclosed benefits (in value terms) are less than € 1000 each, with a table proportion from one year to the next.
Another observation is that the benefit amounts are identical from one semester to the next, there is no seasonality, unlike for agreements, for which there are more disclosed at the beginning of the years as opposed to the end of the year.
It is the drug sector, followed by the medical device sector, that provides the most benefits in terms of amount. Then comes, to a lesser extent, that of the associated providers.
- Analysis of Conventions
For the time being, this analysis can only relate to the number of agreements disclosed, and not to the amount.
The evolution of the number of agreements demonstrates a small seasonality with more agreements published in the first half of the year, and a stable number of agreements from 2014 and 2015 (same in 2016).
- Analysis of disclosing companies
After the “recruitment” phase from 2011 to 2013, there has been a steady increase in the number of companies reporting. This trend continued to develop in 2014 and 2015.
A parallelism can be drawn between the evolution of the amount of benefits disclosed over time and the evolution of the number of companies disclosing. This demonstrates that the increase in the total amount of benefits disclosed is directly related to the fact that the number of reporting companies has increased.
Finally, the analysis by sector and year from 2012 to 2015 highlights the medical device industry as the largest contributor to the number of companies disclosing, followed by the pharmaceutical industry and then the associated providers. The cosmetics industry is quite marginal.