We might have to add the NHP to our list of items to thank on Thanks Giving.
The NHP sent out a new BEEP this last week (Oct 05, 2011). It is both encouraging and problematic. I have bolded many of the sections that are most significant. First, the good news:
- The Directorate has specifically asked for more input from stakeholder and especially practitioner on the way they use Enzymes and Probiotics. They ask for the stakeholders to get one or more practitioners to state how they use these products over what period of time. This is an important policy. Even though the NHP has stated that expert opinion can be used, it has rarely been accepted on applications. This is a clear note that we do not want to miss. Expert opinion is very important for applications of an innovative, unique and novel nature. Without this aspect we will only have me-too-products.
- The NHP has clearly seen a number of stakeholder questions related to this issue, or they would not be issuing another BEEP, all be it right before the Thanks Giving weekend.
- “NHPD sees the use of one independent practitioner as an element of a balanced approach” Many have complained about this, as applicants have to provide two scientific, peer reviewed, human clinical trials documents for consideration in an application. One has to ask if this is an even playing field.
So the bottom line is, we need as many practitioners as possible to document their clinical observations, uses and opinions for Digestive enzymes and probiotics. If we do not do this within the next while, we will lose them from the public use. This has already happened in other countries. I know we are a country of apathetic people, not wanting to weigh in on things unless it affects us directly. This one can affect our decedents for a hundred years to come. After all, Digestion is the cornerstone of many healing traditions around the world.
Background : (here is the BEEP)
On September 14, 2011, the Natural Health Products Directorate (NHPD) communicated via its email distribution service (BEEP) the path forward with respect to evidence requirements for natural health products (NHPs) containing probiotics and enzymes.
Subsequently, the NHPD began contacting licensees and applicants, by way of Information Request Notices (IRNs) and section 16 notices, to gather additional information and to provide licensees and applicants with options and inform them of the available tools. Since the issuance of the BEEP message and associated notices, the NHPD has received correspondence from affected stakeholders.
The purpose of this message is to address some of the questions raised.
The new monograph and abbreviated labelling standards (AbLSs) are intended as tools to assist applicants and licensees in completing their applications for these products. These documents do not represent the only means of obtaining a product licence. The option of providing additional evidence to support safety and efficacy outside the scope of these documents is always available. In addition, the NHPD monitors new evidence as it becomes available and regularly revises its pre-cleared information documents to ensure minimal review timelines and adjust its action plans as required.
Timelines and Transition Period
Based on previous requests for information, the NHPD believes stakeholders have already provided NHPD with all relevant data. However, the IRNs and section 16 notices provide stakeholders with a further opportunity to provide any new data that they may already have in their possession but have not yet communicated to NHPD. The timeline to respond to requests for information is therefore considered to be appropriate, however there may be extenuating circumstances that warrant consideration of an extension, and we encourage those situations and justifications to be outlined in any written responses.
In addition to the tools available, there is a one-year transition period to make required formulation and/or labelling changes in order to ensure minimal market disruption. The ability of industry to comply with this transition period will be assessed on an ongoing basis.
With respect to enzymes, the NHPD sought the advice of the Enzyme Technical Association (ETA) and an independent health care practitioner (practising naturopathic doctor) to inform the development of the AbLSs. NHPD sees the use of one independent practitioner as an element of a balanced approach; in health product decision-making an expert opinion is often sought and then utilized as one input among many.
Stakeholders are invited to seek independent advice from one or more practitioners as appropriate and provide that information to the NHPD. Information that would assist NHPD includes number of years of clinical use, conditions and duration of use, any noted adverse reactions, etc.
Going forward, the NHPD will continue to work with various stakeholders throughout this process by considering any additional information it receives, and will keep stakeholders apprised of further developments.
The Natural Health Products Directorate, Health Canada