Education and regulation for the EU cannabis market
Submitted by Marijuana News on Wed, 07/08/2020 – 08:41
James O’Dowd, Secretary General of the European Alliance for Medicinal Cannabis, talks cannabis policy and oversight in the EU cannabis market.
The European Alliance for Medicinal Cannabis was (EAMC) established in 2019 with the aim of providing a clear, unified voice representing the EU’s cannabis industry in advocacy and lobbying for coherent cannabis policy. EAMC Secretary General James O’Dowd tells MCN about the alliance’s work, the need for broader education for policymakers, and the benefits of an incremental regulatory approach into the cannabis market.
What role does the EAMC occupy within the European medical cannabis industry? What are your key objectives?
We are a Brussels-based trade association; and our role is to interact with the European Union and its institutions to ensure a sensible policy towards medicinal cannabis. At the moment we don’t have an EU-wide cannabis policy from the European Commission, but as more and more countries are adopting medicinal cannabis access programmes and the value of this industry multiplies the Commission will certainly begin to take an interest in that. The EAMC’s role is really to ensure that we are educating officials – not just in the Commission, but also in the European Parliament and the European Council – so that we have knowledgeable allies throughout those three institutions when the time comes for regulation.
How should EU policy evolve to ensure a more standardised regulatory landscape?
One of our key advantages is that all of our leadership personnel either work within the EU institutions or in Brussels-based trade associations; so we understand the Commission and how it works. One way in which policy should not evolve, but which some are advocating, is a copy and paste model based on German policy, whereby they would simply take the German model and adopt it EU-wide. That won’t work; it’s not realistic. There needs to be a much more incremental approach to this, building a case for regulation using numbers, using patient data; and using cross-border trade in particular, because this is one of the key reasons the European Commission implements regulation: to ensure that the integrity of the single market is respected. As these products cross borders it is necessary to regulate to ensure that this happens.
We have a decent model in the Herbal Medicinal Products Directive: that process got underway in 1996, because at the time parliamentarians were concerned that a lot of herbal medicine products – which as we all know don’t go through the same marketing authorisation procedures as traditional medical products – were crossing the borders of EU Member States in great numbers. The European Commission issued a directive which laid out a basic framework for regulating the trade and marketing of these products; so we think that provides a good template for how EU policy on cannabis should evolve.
How can industry stakeholders contribute to ensuring high quality and safety standards?
That’s a key goal of the European Alliance for Medicinal Cannabis: what we would envisage – and we have a good template in terms of the Herbal Medicinal Products Directive – there is a committee associated with that directive, the Herbal Medicinal Products Committee, which sits in the European Medicines Agency. The committee’s goal is to ensure the high quality and safety standards of herbal medicinal products: we would envisage a similar committee, whereby national regulators would draw on the expertise of industry stakeholders. Bear in mind that this is a very new industry, and we have limited experience of broad medicinal cannabis access programmes like those in place in Canada; so industry stakeholders, with the knowledge they have gained from being active in those markets, can play a key role in Europe. Contributing to a body like that is going to be a very important element going forward.
As cannabis becomes more widely accepted in a growing number of Member States, should EU policymakers be better educated on the scientific background of the medical applications of cannabis? How could this be achieved?
Education is extremely important – it’s a very new market, it’s a new industry, a lot of people are having a hard time distinguishing between the different forms and products. We absolutely need to be better educated on this; that’s another key goal of the EAMC. As to how this can be achieved, we think a very important area is the European Union’s own research funding budget: between 2007 and 2019, between the European Union’s research programmes, FP7, MP8 and Horizon 2020, only €40m was allocated to research into the scientific and medicinal properties of cannabinoids – and €40m might sound like a decent amount, but over that period the full budget was close to €100bn, so really it was a drop in the ocean.
The budget for the forthcoming research programme, Horizon Europe, is estimated to be around €90 billion; but we want to see the European Union allocating a lot more resources towards providing scientific underpinning for the medicinal applications of cannabis. Policymakers everywhere trust their own research better than research from external bodies such as the US Food and Drug Administration (FDA); people in Europe believe we hold ourselves to a higher standard, so that’s going to be a really important part of what we do. It’s going to be important for the industry to ensure that policymakers can stand behind you know the scientific claims around medicinal cannabis.
How do you foresee EU policy on medical cannabis evolving over the European Commission’s next term, from 2019 to 2024?
We’re going to need a series of incremental steps. One of the key priorities Commission is the Beating Cancer Plan: that is an overarching priority for the Directorate General for Health and Food Safety and for its Commissioner Stella Kyriakides, who has a background in cancer advocacy. Commissioner Kyriakides herself has said that we can’t talk about a cancer plan unless we are able to provide a pipeline of affordable treatments to alleviate the suffering of cancer patients. One of the conditions for which medicinal cannabis can be legally used in several EU Member States is for patients undergoing chemotherapy; and we think that medicinal cannabis should play a very important role going forward in the EU’s cancer plan. If we all acknowledge – and several Member States already do, even conservative ones such as Ireland – that medicinal cannabis has played a role in helping patients through the very difficult process of chemotherapy, we think the EU needs to take this seriously and incorporate it as part of the cancer plan. We think that’s going to be one very incremental step in getting toward the more standardised framework.
It is now the case that more EU Member States have cannabis access programmes than not, and we’ll get to a situation as more and more adopt it wherein the value of the EU cannabis market, the quantity of cross-border trade, and the number of jobs involved will all grow exponentially. The EU will have to act to regulate to maintain the integrity of the single market as the value of the medicinal cannabis market evolves. The incremental steps are going to be very important in increasing acceptance of the medicinal properties of cannabis; and then, as Member States continue to evolve themselves, it becomes something that the Commission cannot ignore.
Are there any developments or issues in the medical cannabis industry which you would like to highlight?
One big problem which has been highlighted by several MEPs relates to the lack of access to medicines – that’s not limited to specialist or complex medicines, but also the most basic medicine can be hard to come by, both in poorer nations and in highly developed countries. It is possible that wider prescription of medicinal cannabis could play a role towards alleviating shortages, it’s just a matter of educating policymakers about that potential role.
Source: 420Intel Newsletter
Submitted by Marijuana News on Wed, 07/08/2020 – 08:41
James O’Dowd, Secretary General of the European Alliance for Medicinal Cannabis, talks cannabis policy and oversight in the EU cannabis market.
The European Alliance for Medicinal Cannabis was (EAMC) established in 2019 with the aim of providing a clear, unified voice representing the EU’s cannabis industry in advocacy and lobbying for coherent cannabis policy. EAMC Secretary General James O’Dowd tells MCN about the alliance’s work, the need for broader education for policymakers, and the benefits of an incremental regulatory approach into the cannabis market.
What role does the EAMC occupy within the European medical cannabis industry? What are your key objectives?
We are a Brussels-based trade association; and our role is to interact with the European Union and its institutions to ensure a sensible policy towards medicinal cannabis. At the moment we don’t have an EU-wide cannabis policy from the European Commission, but as more and more countries are adopting medicinal cannabis access programmes and the value of this industry multiplies the Commission will certainly begin to take an interest in that. The EAMC’s role is really to ensure that we are educating officials – not just in the Commission, but also in the European Parliament and the European Council – so that we have knowledgeable allies throughout those three institutions when the time comes for regulation.
How should EU policy evolve to ensure a more standardised regulatory landscape?
One of our key advantages is that all of our leadership personnel either work within the EU institutions or in Brussels-based trade associations; so we understand the Commission and how it works. One way in which policy should not evolve, but which some are advocating, is a copy and paste model based on German policy, whereby they would simply take the German model and adopt it EU-wide. That won’t work; it’s not realistic. There needs to be a much more incremental approach to this, building a case for regulation using numbers, using patient data; and using cross-border trade in particular, because this is one of the key reasons the European Commission implements regulation: to ensure that the integrity of the single market is respected. As these products cross borders it is necessary to regulate to ensure that this happens.
We have a decent model in the Herbal Medicinal Products Directive: that process got underway in 1996, because at the time parliamentarians were concerned that a lot of herbal medicine products – which as we all know don’t go through the same marketing authorisation procedures as traditional medical products – were crossing the borders of EU Member States in great numbers. The European Commission issued a directive which laid out a basic framework for regulating the trade and marketing of these products; so we think that provides a good template for how EU policy on cannabis should evolve.
How can industry stakeholders contribute to ensuring high quality and safety standards?
That’s a key goal of the European Alliance for Medicinal Cannabis: what we would envisage – and we have a good template in terms of the Herbal Medicinal Products Directive – there is a committee associated with that directive, the Herbal Medicinal Products Committee, which sits in the European Medicines Agency. The committee’s goal is to ensure the high quality and safety standards of herbal medicinal products: we would envisage a similar committee, whereby national regulators would draw on the expertise of industry stakeholders. Bear in mind that this is a very new industry, and we have limited experience of broad medicinal cannabis access programmes like those in place in Canada; so industry stakeholders, with the knowledge they have gained from being active in those markets, can play a key role in Europe. Contributing to a body like that is going to be a very important element going forward.
As cannabis becomes more widely accepted in a growing number of Member States, should EU policymakers be better educated on the scientific background of the medical applications of cannabis? How could this be achieved?
Education is extremely important – it’s a very new market, it’s a new industry, a lot of people are having a hard time distinguishing between the different forms and products. We absolutely need to be better educated on this; that’s another key goal of the EAMC. As to how this can be achieved, we think a very important area is the European Union’s own research funding budget: between 2007 and 2019, between the European Union’s research programmes, FP7, MP8 and Horizon 2020, only €40m was allocated to research into the scientific and medicinal properties of cannabinoids – and €40m might sound like a decent amount, but over that period the full budget was close to €100bn, so really it was a drop in the ocean.
The budget for the forthcoming research programme, Horizon Europe, is estimated to be around €90 billion; but we want to see the European Union allocating a lot more resources towards providing scientific underpinning for the medicinal applications of cannabis. Policymakers everywhere trust their own research better than research from external bodies such as the US Food and Drug Administration (FDA); people in Europe believe we hold ourselves to a higher standard, so that’s going to be a really important part of what we do. It’s going to be important for the industry to ensure that policymakers can stand behind you know the scientific claims around medicinal cannabis.
How do you foresee EU policy on medical cannabis evolving over the European Commission’s next term, from 2019 to 2024?
We’re going to need a series of incremental steps. One of the key priorities Commission is the Beating Cancer Plan: that is an overarching priority for the Directorate General for Health and Food Safety and for its Commissioner Stella Kyriakides, who has a background in cancer advocacy. Commissioner Kyriakides herself has said that we can’t talk about a cancer plan unless we are able to provide a pipeline of affordable treatments to alleviate the suffering of cancer patients. One of the conditions for which medicinal cannabis can be legally used in several EU Member States is for patients undergoing chemotherapy; and we think that medicinal cannabis should play a very important role going forward in the EU’s cancer plan. If we all acknowledge – and several Member States already do, even conservative ones such as Ireland – that medicinal cannabis has played a role in helping patients through the very difficult process of chemotherapy, we think the EU needs to take this seriously and incorporate it as part of the cancer plan. We think that’s going to be one very incremental step in getting toward the more standardised framework.
It is now the case that more EU Member States have cannabis access programmes than not, and we’ll get to a situation as more and more adopt it wherein the value of the EU cannabis market, the quantity of cross-border trade, and the number of jobs involved will all grow exponentially. The EU will have to act to regulate to maintain the integrity of the single market as the value of the medicinal cannabis market evolves. The incremental steps are going to be very important in increasing acceptance of the medicinal properties of cannabis; and then, as Member States continue to evolve themselves, it becomes something that the Commission cannot ignore.
Are there any developments or issues in the medical cannabis industry which you would like to highlight?
One big problem which has been highlighted by several MEPs relates to the lack of access to medicines – that’s not limited to specialist or complex medicines, but also the most basic medicine can be hard to come by, both in poorer nations and in highly developed countries. It is possible that wider prescription of medicinal cannabis could play a role towards alleviating shortages, it’s just a matter of educating policymakers about that potential role.
Source: 420Intel Newsletter
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