Bill 102 and the Issues Facing Industry
The November meeting featured a timely update from Rx&D, graciously and succinctly provided by Walter Robinson (then RX&D’s VP of Corporate Affairs), who filled in for RX&D president Russell Williams.
What’s new? First, the new data protection regulations, which became effective in October. These regulations protect clinical test data for 8 years, and include six months additional protection for medications used in paediatric clinical trials. While there have been some negative headlines concerning data protection, noted Mr Robinson, it is important to understand that data protection is not patent protection, and such regulations will not make drugs more expensive.
The controversial Bill 102 (the Transparent Drug System for Patients Act) was adopted by the Ontario government in the fall. Not welcomed by pharmacists, and not well understood by physicians, it is, says Mr Robinson, “neither transparent, nor a system”. Simply, it focuses on cost containment; the key elements include price roll-backs and promises of greater access – but no benchmarks or timelines are suggested. Manufacturers will have to enter into agreements with the newly appointed Executive Officer. It will be interesting to see what affect this legislation has on other provinces as regards their own individual plans (Quebec’s Politique du médicament, most notably) and on generic pricing.
Several recent improvements to the RX&D Code of Conduct have been sanctioned by member companies. Among these are amendments to Section 2, regarding the dissemination of information by electronic means, Section 4, related to education for healthcare professionals, which sets limits on the practices of training HCPs who will train their peers; Section 4A, concerning CHE, which makes clear the idea that members are responsible for events organized by a third party; Section 12, on market research, which spells out the differences in roles between sales and market research activities, and finally, Section 15, on enforcement, which outlines a reasonable period during which complaints can be registered.
And more good news. The pharmaceutical industry is still in the business of prevention, and the dividends to Canadians are huge…clean water, vaccinations, new and better medications. RX&D has 54 members at present – including more biotech companies. And last year’s launch of the Hearts and Mind awareness campaign put a face to an industry that is a huge part of the country’s infrastructure as a gatekeeper of public health safety and security, and as an employer of thousands.
By Patricia Brown
Breakfast: 7:00 am
Presentation: 7:30 pm