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What Is Going On With Germany’s Cannabis Bid? By Marguerite Arnold

A number of setbacks, controversies and lawsuits keep the German cannabis market in limbo.

Germany is proceeding down the path to officially grow its own medical cannabis crops. Medical use became legal this year, along with a federal mandate for cheap access. That means that public health insurance companies, which cover 90% of Germans, are now firmly on the hook if not front line of the cannabis efficacy issue. As such, Germany’s medical market is potentially one of the most lucrative cannabis markets in the world, with a total dollar amount to at least challenge, if not rival, even California’s recreational market. Some say Canada’s too.

However, before “home grow” enthusiasts get too excited, this legislative move was an attempt to stymie everything but commercial, albeit medical production. Not to mention shut off the recreational discussion for at least another four years.

How successful that foray into legalization will be – especially given the chronic shortages now facing patients – are an open question. Not to mention other infrastructural issues – like doctor unfamiliarity with or resistance to prescribing cannabinoids. Or the public insurers’ so-far reluctance to cover it even though now federally mandated to do so.

Regardless, Germany decided to legalize medical use in 2017 and further to begin a sanctioned domestic cultivation for this market. The decision in the Bundestag to legalize the drug was unanimous. And the idea to follow UN regulations to establish this vertical is cautiously conservative but defendable. Very predictably German in other words.

Since then, however, the path has been far from smooth. Much less efficient.

Trouble in Germany’s Medical Cannabis Paradise
In April the government released its tender bid. And no matter how exciting it was to be in the middle of an industry who finally saw a crack of light, there were also clouds to this silver lining that promised early and frequent thunderstorms on the horizon.

By the time the tender bid application was due in June, it was already clear who the top firms were likely to be In fact, by the end of the ICBC conference, which held its first annual gathering in Berlin at the same time the bid tender was announced, the controversy was already bubbling. The requirements of the bid, for a laughably small amount of cannabis (2,000 kg), mandated experience producing high qualities of medical marijuana in a federally legitimate market. By definition that excluded all German hopefuls, and set up Canada and Holland as the only countries who could provide such experience, capital and backlog of crop as the growing gets started.

The grumbling from Germans started then.

However, so did an amazingly public race to gain access to the German market directly – by acquisition or capital expenditures that are not refundable easily (like real estate or even buyouts). The common theme? They were large amounts of money being spent, and made by major Canadian Licensed Producers who had the right qualifications to meet the standards of the bid. In fact, by the time the tender bid application was due in June, it was already clear who the top firms were likely to be. They were the only ones who qualified under the judging qualifications.

And while nobody would commit publicly, news of the final decision was expected by August. Several Canadian LPs even issued press releases stating that they were finalists in the bid. But still no news was forthcoming about the official list.

Delay, Delay and More Delay
A month later, as of September, and there was still no official pronouncement. Nor was anybody talking. BfArM, the regulatory agency that is supervising this rollout as well as the regulation of all narcotic drugs (sort of like a German version of the FDA) has been issuing non-statement statements since the late summer. Aurora, however, one of the top contenders for cultivation here, was quietly issued an ex-im license by both Canadian and German authorities. Publicly, this has been described as an effort to help stem the now chronic cannabis shortage facing patients who attempt to go through legitimate, prescribed channels. On the German side, intriguingly, this appears to be a provisional license. Privately, some wondered if this was the beginning of a backdoor approval process for the top scoring bid applicants for cultivation. Although why that might be remains unclear.

Whispered rumours by industry sources that wish to remain anonymous, have suggested that the entire bid is still hanging in jeopardy. Late in the month, rumours began to fly that there were now lawsuits against the bid process. Nobody had much detail. Not to mention specifics. But CannabisIndustryJournal can now confirm in fact that there have been two lawsuits (so far).

The summary of the complaints? It appears that two parties, filing with the “Bundeskartellamt” (or regulatory office focusing on monopolies and unfair business practices) did not think the bid process or scoring system was fair. And both parties also lost.

But as of mid-October, there is still no public decision on the bids. What gives?

Whispered rumours by industry sources that wish to remain anonymous, have suggested that the entire bid is still hanging in jeopardy. Even though the plaintiffs failed, some have suggested that the German government might force a complete redo. Others hint that it will likely be slightly revised to be more inclusive but the regulatory standards must remain. If a redo is in the cards, will the German government decide to increase the total amount of yearly cannabis to be delivered? At this point, it is only calling for 2,000 kg per year by 2019. And that, as everyone knows, is far too little for a market that is exploding no matter the many other obstacles, like insurance companies refusing to compensate patients.

What Is Behind The Continued Delays?
There are several theories circulating the higher levels of the cannabis industry internationally right now even if no one is willing to be quoted. The first is that the total number of successful applicants, including the recent litigants, will be slightly expanded, but stay more or less the same. There is a high standard here for the import of medical cannabis that the Germans intend on duplicating domestically.

The Comprehensive Economic Trade Agreement (CETA – the often controversial free trade alliance between Europe and Canada) is still in the final stages of approval.The second is that the German government will take its time on announcing the final winners and just open the doors to more imported product. This will not be popular with German insurers, who are on the hook to pay the difference. However with Tilray now on track to open a processing facility in Portugal and Canopy now aligned with Alcaliber in Spain, cross-continent import might be one option the government is also weighing as a stop-gap provision. Tilray, who publicly denied in the German press that they were participating in the cultivation license during the summer, just issued a press release in October announcing a national distribution deal to pharmacies with a German partner – for cannabis oil.

But then there is another possibility behind the delay. The government might also be waiting for another issue to resolve – one that has nothing to do with cannabis specifically, but in fact is now right in the middle of the discussion.

The Comprehensive Economic Trade Agreement (CETA – the often controversial free trade alliance between Europe and Canada) is still in the final stages of approval. In fact, on September 19, a prominent German politician, Sigmar Gabriel of the Social Democrats (SPD) made a major statement about his party’s willingness to support Germany’s backing of the deal. It might be in fact, that the German government, which is supportive of CETA, got spooked about the cannabis lawsuits as test trials against not cannabis legalization, but a threat to the treaty itself.

Quality control, namely pesticides when it comes to plant matter, and the right of companies to sue governments are two of the most controversial aspects of this trade deal. And both appear to have risen, like old bong smoke, right at the final leg of closing the cannabis cultivation bid.

Will cannabis be seen as a flagship test for the seaworthiness of CETA? On a very interesting level, that answer may be yes. And will CETA in turn create a different discussion about regulatory compliance in an industry that has been, from the beginning of this year, decidedly Canadian-Deutsch? That is also on the table. And of great concern to those who follow the regulatory issues inherent in all. Not to mention, of course, the industry itself.

Conclusions?
Right now, there are none to be had.

However at present, the German bid process is several months behind schedule as Canadian producers themselves face a new wrinkle at home – the regulation of the recreational crop in the provinces.

It is also clear that there are a lot of questions and not a whole lot of answers. Not to mention a timeline when the smoke will clear.

Marguerite Arnold
Founder
MedPayRx
Marguerite Arnold is an American expat now living in Germany. She has just recieved her EMBA from the Frankfurt School of Finance and Management. She has a 25 year background in both cannabis reform and technology. She has been covering the international marijuana industry as a journalist and author since 2014. She continues to cover developments in the industry as she launches her own cannabis-tech firm, a company called MedPayRx, which aspires to be the first insurance and banking solution for cannabis patients in the world.

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European Union COMMISSION DELEGATED REGULATION (EU) 2017/1155 of 15 February 2017 amending Delegated Regulation (EU) No 639/2014 as regards the control measures relating to the cultivation of hemp

30.6.2017
EN
Official Journal of the European Union
L 167/1
COMMISSION DELEGATED REGULATION (EU) 2017/1155
of 15 February 2017
amending Delegated Regulation (EU) No 639/2014 as regards the control measures relating to the cultivation of hemp, certain provisions on the greening payment, the payment for young farmers in control of a legal person, the calculation of the per unit amount in the framework of voluntary coupled support, the fractions of payment entitlements and certain notification requirements relating to the single area payment scheme and the voluntary coupled support, and amending Annex X to Regulation (EU) No 1307/2013 of the European Parliament and of the Council
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 1307/2013 of the European Parliament and of the Council of 17 December 2013 establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and repealing Council Regulation (EC) No 637/2008 and Council Regulation (EC) No 73/2009 (1), and in particular Article 35(2) and (3), Articles 44(5)(b) and 46(9)(a) and (c), Article 50(11), Article 52(9)(a) and Article 67(1) and (2)(a) thereof,
Whereas:
(1)
According to Article 35(3) of Regulation (EU) No 1307/2013, the Commission is empowered to adopt delegated acts making the granting of payments conditional upon the use of certified seeds of certain hemp varieties and laying down the procedure for the determination of hemp varieties and the verification of their tetrahydrocannabinol content (THC content) referred to in Article 32(6) of that Regulation. At present, Article 9 of Commission Delegated Regulation (EU) No 639/2014 (2) only provides for the obligation to use seed of the varieties listed in the ‘Common Catalogue of Varieties of Agricultural Plant Species’ and to use seed certified in accordance with Council Directive 2002/57/EC (3). The rules for the determination of hemp varieties and the verification of their THC content currently laid down in Article 45 of Commission Implementing Regulation (EU) No 809/2014 (4) and the Annex to that Regulation should be included in Article 9 of Delegated Regulation (EU) No 639/2014.
(2)
The rules for the determination of hemp varieties and the verification of the THC content are based on the assumption that hemp is cultivated as main crop, but they are not fully suitable for hemp cultivated as catch crop. As this latter cultivation method has proved to be appropriate for industrial hemp and compatible with environmental requirements, it is justified to adapt both provisions to take into account the characteristics of hemp cultivated as catch crop. In that context, it is also appropriate to provide a definition of hemp cultivated as catch crop.
(3)
Article 24 of Delegated Regulation (EU) No 639/2014 lays down requirements for the activation of payment entitlements. In order to avoid any diverging interpretation, it is appropriate to clarify that for the purposes of Article 31(1)(b) of Regulation (EU) No 1307/2013, also a fraction of a payment entitlement is considered as fully activated. However, it should be stated explicitly that the payment is calculated on the basis of the corresponding fraction of an eligible hectare.
(4)
Articles 38 to 48 of Delegated Regulation (EU) No 639/2014 lay down rules supplementing the provisions on standard greening practices established by Regulation (EU) No 1307/2013. On the basis of the experience gained during the first year in which those practices were applied, it is necessary to amend certain aspects of those rules in order to simplify the implementation of the greening practices for the benefit of farmers and national administrations while maintaining or improving the environment and climate impact. In particular, the modifications should contribute to address the actions identified in the conclusions of the Mid-Term Review of the EU Biodiversity Strategy to 2020 and enable progress of the coverage of agricultural area by biodiversity related measures under the common agricultural policy (5).
(5)
In the rules on the calculation of shares of different crops for crop diversification set out in Article 40 of Delegated Regulation (EU) No 639/2014, the crop diversification period is based on traditional cultivation practices in Member States. It is appropriate to allow Member States to fix different periods at regional or sub-regional level in order to take into account possible diverse climatic conditions within a territory of a Member State. In some specific situations where a significant variety of crops on a small area exists, it should be possible, in order to simplify the declaration of crops grown, to declare them as one mixed crop.
(6)
As regards land lying fallow, setting a period in Article 45(2) of Delegated Regulation (EU) No 639/2014 during which there should be no agricultural production is fundamental to ensure the environmental effectiveness of such land and to avoid any confusion with other areas such as grasslands. In order to take into account the different agro-climatic conditions across the Union, Member States should have the possibility to set such period to allow farmers to resume main crops before the end of the year. However, such period should not be shorter than 6 months in order to meet the objectives of environmental effectiveness and to avoid any confusion with other areas.
(7)
The distinction between different landscape features listed in Article 45(4) of Delegated Regulation (EU) No 639/2014 is a source of uncertainty for farmers when declaring ecological focus areas. In order to reduce this uncertainty, simplify the management of the scheme for Member States’ authorities and address the complexity encountered by farmers when declaring ecological focus areas, hedges and wooded strips referred to in point (a) of that provision and trees in line referred to in point (c) of that provision should be grouped as one type of landscape feature so that one single dimension limit applies to them. Moreover, for the same reasons, the areas referred to in Article 45(4)(d) of Delegated Regulation (EU) No 639/2014 should be grouped under field copses.
(8)
Furthermore, even if, as stated in recital 51 of Delegated Regulation (EU) No 639/2014, maximum dimensions of landscape features are needed to ensure that the area is predominantly agricultural, such dimension limits should not lead to the exclusion of features that exceed such dimensions but which are valuable for biodiversity. Therefore, the area which may be qualified as a landscape feature pursuant to Article 45(4) of Delegated Regulation (EU) No 639/2014 should be calculated up to the maximum dimension of the feature.
(9)
Given the high environmental benefit of riparian vegetation referred to in the fifth subparagraph of Article 45(4) and in Article 45(5) of Delegated Regulation (EU) No 639/2014, it is appropriate to set out that all riparian vegetation should be taken into account for the purpose of calculating the ecological focus areas.
(10)
For the same reasons as mentioned in recitals 7 and 8 in relation to Article 45(4) of Delegated Regulation (EU) No 639/2014, field margins, currently referred to in point (e) of that provision, should be merged with buffer strips in Article 45(5) of that Regulation and a single dimension limit should be set in relation to buffer strips and field margins. Such maximum dimension in relation to buffer strips and field margins should refer to the area which may be qualified as buffer strips and field margins pursuant to Article 45(5) of Delegated Regulation (EU) No 639/2014. In order to provide the maximum flexibility to farmers, the definition of buffer strips under GAEC 1, SMR 1 or SMR 10 as referred to in Annex II to Regulation (EU) No 1306/2013 of the European Parliament and of the Council (6) and field margins protected under GAEC 7, SMR 2 or SMR 3 as referred to in that Annex, should be supplemented by other buffer strips and field margins, meaning any kind of strips not covered by these two categories under cross-compliance rules.
(11)
The second subparagraph of Article 46(2) of Regulation (EU) No 1307/2013 allows landscape features and buffer strips adjacent to arable land to be considered as ecological focus areas. In order to maximise the environmental benefit of landscape features and buffer strips referred to in Article 45(4) and (5) of Delegated Regulation (EU) No 639/2014 and encourage the protection and maintenance of additional elements, this provision should be supplemented with rules offering flexibility by taking into account other environmentally valuable elements which fulfil the definition of these ecological focus area types and which are not adjacent to the arable land of the holding. Therefore, where such buffer strip and field margin or landscape feature is adjacent to the ecological focus area directly adjacent to the arable land of a holding, it should also be recognised as an ecological focus area.
(12)
For the same reasons as mentioned in recitals 7 and 8 in relation to Article 45(4) of Delegated Regulation (EU) No 639/2014, the maximum dimensions set in relation to strips of eligible hectares along forest edges referred to in Article 45(7) of that Regulation should refer to the area which may be qualified as such strips pursuant to that provision.
(13)
In light of the provisions of point (g) of the first subparagraph of Article 46(2) of Regulation (EU) No 1307/2013 it is appropriate to clarify that the establishment of the requirements as regards the use of mineral fertilisers and/or plant protection products is relevant only in case such input products are authorised.
(14)
The existing deadline for sowing of catch crops and green cover laid down in Article 45(9) of Delegated Regulation (EU) No 639/2014 does not always fit with the agronomic and climatic conditions. With a view to better achieving the environmental objectives of this ecological focus area type, it is appropriate to replace the deadline for sowing of catch crops and green cover with a minimum period of time during which areas under catch crops and green cover have to be in place. In order to provide the necessary flexibility to take into account seasonal weather conditions, Member States should be allowed to fix that period at the most appropriate geographical level. However, since the permanence of catch crops and green cover on the ground is a key factor in ensuring an effective take up of residual nitrate and coverage of soil while the area is not covered by the main crop, the minimum length of the period should be set at Union level. In order to be consistent with the interpretation provided on the definition of grasses or other herbaceous forage laid down in Article 4(1)(i) of Regulation (EU) No 1307/2013, under-sowing leguminous crops in the main crop should also be possible. Furthermore, in order to ensure consistency between equivalent practices covered by commitments and certification schemes as referred to in Article 43(3)(a) and (b) of Regulation (EU) No 1307/2013, respectively, rules on qualifying catch crops or green cover as ecological focus areas should be aligned.
(15)
Even if, as a general rule only areas with nitrogen-fixing crops grown as pure species should be qualified as ecological focus areas, given that in traditional cultivation practices such crops are often mixed with other crops, it is appropriate to allow, under Article 45(10) of Delegated Regulation (EU) No 639/2014, that areas with mixtures may also be qualified as ecological focus areas provided that the predominance of the nitrogen-fixing crops in such mixtures is ensured. In addition, based on the experience with the application of the first subparagraph of Article 45(10) of Delegated Regulation (EU) No 639/2014 and in light of the implementation of Council Directive 91/676/EEC (7) and Directive 2000/60/EC of the European Parliament and of the Council (8), it is superfluous to prescribe specific rules on the location of these nitrogen-fixing crops. Instead, and with a view to strengthening Member States efforts to address the risk of nitrogen leaching in the autumn, Member States should be allowed to establish additional conditions on nitrogen-fixing crops if necessary. Furthermore, in order to ensure consistency between equivalent practices covered by commitments and certification schemes as referred to in Article 43(3)(a) and (b) of Regulation (EU) No 1307/2013, respectively, rules on qualifying nitrogen-fixing crops as ecological focus area should be aligned.
(16)
Experience with the application of Delegated Regulation (EU) No 639/2014 has proven that certain provisions relating to the ecological focus area types need to be more detailed as regards the requirement of ‘no production’ including the rules on cutting and grazing with a view to meeting the objective of biodiversity and to ensuring consistency with other instruments of the common agricultural policy. In particular, as regards the ‘no agricultural production’ requirement applicable to the ecological focus area types referred to in Article 45(2), (4)(e), (5) and (7) of Delegated Regulation (EU) No 639/2014, it should be clarified that production should be understood as agricultural activity in the meaning of Article 4(1)(c)(i) of Regulation (EU) No 1307/2013, and not in the broader sense of Article 4(1)(c)(ii) and (iii) of the same Regulation, and should not affect the rules on minimum soil cover under GAEC 4 as referred to in Annex II to Regulation (EU) No 1306/2013. In addition, undertaking actions by farmers, in particular, by facilitating pollination, in order to safeguard and improve biodiversity, aiming at establishing a green soil cover and which are, for instance, covered by an agri-environment-climate commitment, should be incentivised to maximise the environmental benefits.
(17)
Given that the three main types of areas declared by farmers as ecological focus areas in the first year of implementation of Article 46 of Regulation (EU) No 1307/2013 are areas which are, or may be, productive, namely land lying fallow, catch crops or green cover and nitrogen-fixing crops, plant production products are likely to be used in ecological focus areas. Therefore, in order to safeguard and improve biodiversity in line with the objectives of ‘greening’, it is appropriate to ban the use of plant protection products on the following ecological focus areas which are or may be productive: land lying fallow, strips of eligible hectares along forest edges with production, catch crops or green cover and nitrogen-fixing crops. Where catch crops or green cover is established by under-sowing grass or leguminous crops in the main crop, in order to avoid, for proportionality reasons, consequences for the management of the main crop, such a ban should apply from the moment of the harvesting of the main crop. In order to ensure consistency of the ban with the usual agronomic practices, ensure legal certainty and avoid administrative difficulties for farmers and national administrations it should be specified that the ban for under-sowing should apply for at least a minimum period, equal to the minimum period during which areas under catch crops or green cover have to be in place when established by sowing a mixture of crop species, or until the sowing of the next main crop.
(18)
Article 49 of Delegated Regulation (EU) No 639/2014 lays down the rules under which legal persons have access to the payment for young farmers provided for in Article 50(1) of Regulation (EU) No 1307/2013. On the basis of the experience gained with the application of Article 49(3) of Delegated Regulation (EU) No 639/2014, a further clarification should be provided as to the interpretation of the requirement laid down in point (b) of Article 50(2) of Regulation (EU) No 1307/2013 in respect of the time when a young farmer who exercises effective and long-term control over a legal person has to comply with the age limit. In particular, it is appropriate to clarify that the young farmer has to comply with the age limit of 40 years in the year of the first submission of an application under the basic payment scheme or the single area payment scheme by the legal person with a young farmer in control.
(19)
According to the second subparagraph of Article 53(2) of Delegated Regulation (EU) No 639/2014, the per unit amount of voluntary coupled support results from the ratio between the amount fixed for the financing of the relevant measure and either the quantitative limit fixed pursuant to the first subparagraph of Article 53(2), or the number of hectares or animals that are eligible for the support in the year in question. It is appropriate to reformulate that provision in such a way that Member States may fix the per unit amount at a value within the range between those two values where the number of eligible units is lower than the quantitative limit.
(20)
Pursuant to Article 64(5) of Delegated Regulation (EU) No 639/2014, Member States applying the single area payment scheme in accordance with Article 36 of Regulation (EU) No 1307/2013 are to notify the Commission by 1 September each year of the total number of hectares declared by farmers under that scheme. However, that information is notified to the Commission annually in more detail pursuant to Article 9(1) of Implementing Regulation (EU) No 809/2014. Article 64(5) of Delegated Regulation (EU) No 639/2014 can therefore be deleted.
(21)
Based on the Commission’s experience with the management of the notifications relating to greening pursuant to Article 65 to Delegated Regulation (EU) No 639/2014, some adjustments should be made as regards their content, including with respect to greening provisions of Delegated Regulation (EU) No 639/2014 as amended by this Regulation.
(22)
In accordance with Article 67(2) of Delegated Regulation (EU) No 639/2014, Member States are to notify the Commission of the total number of beneficiaries, the amount of the payments which have been granted as well as the total area and the total number of animals for which the support has actually been paid for each coupled support measure and each of the specific types of farming or specific agricultural sectors concerned.
(23)
As from claim year 2015, the total number of beneficiaries and the total area or total number of animals claimed and determined for each voluntary coupled support measure are notified by Member States in accordance with Article 9(1) and (3) of Implementing Regulation (EU) No 809/2014. Furthermore, as from claim year 2016, the amount of the payments which have been granted for each coupled support measure will be included in the communications of information by the Member States in accordance with Article 10 of Commission Implementing Regulation (EU) No 908/2014 (9). Therefore, Article 67(2) of Delegated Regulation (EU) No 639/2014 should be deleted.
(24)
Delegated Regulation (EU) No 639/2014 should therefore be amended accordingly.
(25)
As a consequence of the amendment of certain provisions of Delegated Regulation (EU) No 639/2014 concerning the ecological focus area types, changes to Annex X to Regulation (EU) No 1307/2013 need to be made, in particular by adapting the list of ecological focus area types and the corresponding factors, where necessary. Recital 45 of Regulation (EU) No 1307/2013 emphasises the importance of ecological focus areas to be established in a coherent way. Therefore, conversion and weighting factors applicable to equivalent practices have to be consistent with the factors applicable to similar or identical standard practices. In the interest of legal certainty and equal treatment between farmers, Annex X to Regulation (EU) No 1307/2013 should be amended accordingly.
(26)
This Regulation should enter into force on the third day after its publication. However, as the clarification of Article 49(3) of Delegated Regulation (EU) No 639/2014 and the reformulation of the second subparagraph of Article 53(2) of that Regulation reflect an interpretation given to those provisions since the application of that Regulation, it is appropriate that those amendments apply retroactively. Considering the time necessary for the national authorities to update their existing administrative tools and to inform farmers sufficiently in advance of the amendments of the greening provisions made by this Regulation, those amendments should only apply with respect to aid applications relating to calendar years starting as from 1 January 2018. However, Member States should be given the possibility to apply them with respect to aid applications relating to calendar year 2017 while bearing in mind that any choices in this regard should be coherent from the perspective of farmers. A notification obligation as regards consequential changes to previous notifications relating to that calendar year should be provided for,
HAS ADOPTED THIS REGULATION:
Article 1
Amendment of Delegated Regulation (EU) No 639/2014
Delegated Regulation (EU) No 639/2014 is amended as follows:
(1)
Article 9 is replaced by the following:
‘Article 9
Hemp
1. For the purposes of Article 32(6) of Regulation (EU) No 1307/2013, the eligibility of areas used for the production of hemp shall be subject to the use of seed of the varieties listed in the “Common Catalogue of Varieties of Agricultural Plant Species” on 15 March of the year in respect of which the payment is granted and published in accordance with Article 17 of Council Directive 2002/53/EC (*1). The seed shall be certified in accordance with Council Directive 2002/57/EC (*2).
2. Member States shall establish the system for determining the Δ9-tetrahydrocannabinol content (hereinafter referred to as “THC content”) in hemp varieties, which allows them to apply the method set out in Annex III.
3. The competent authority of the Member State shall keep the records related to findings on the THC content. Such records shall comprise for each variety at least the results in terms of THC content from each sample expressed in percentage to two decimal places, the procedure used, the number of tests carried out, an indication of the point at which the sample was taken and measures taken at national level.
4. If an average of all the samples of a given variety exceeds the THC content as laid down in Article 32(6) of Regulation (EU) No 1307/2013, Member States shall use procedure B as described in Annex III to this Regulation for the variety concerned in the course of the following claim year. That procedure shall be used in the course of the next claim years unless all the analytical results for the given variety are below the THC content as laid down in Article 32(6) of Regulation (EU) No 1307/2013.
5. If for the second year the average of all the samples of a given variety exceeds the THC content as laid down in Article 32(6) of Regulation (EU) No 1307/2013, the Member State shall notify the Commission of the request for authorisation to prohibit the marketing of such variety in accordance with Article 18 of Directive 2002/53/EC. Such notification shall be sent in accordance with Commission Regulation (EC) No 792/2009 (*3) by 15 January of the following claim year at the latest. Starting from that claim year, the variety covered by that request shall not be eligible for direct payments in the Member State concerned.
6. For the purposes of this Regulation, “hemp cultivated as catch crop” means crop of hemp sown after 30 June of a given year.
7. Crops of hemp shall continue to be cultivated under normal growing conditions in accordance with local practice for at least 10 days from the date of the end of flowering so that the checks necessary for the application of this Article can be made. Hemp cultivated as catch crop shall continue to be cultivated under normal growing conditions in accordance with local practice at least until the end of the vegetation period.
However, Member States may authorise hemp to be harvested after flowering has begun but before the end of the 10-day period after the end of flowering, provided that the inspectors indicate which representative parts of each plot concerned must continue to be cultivated for at least 10 days following the end of flowering for inspection purposes, in accordance with the method set out in Annex III.
(*1) Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (OJ L 193, 20.7.2002, p. 1).”
(*2) Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (OJ L 193, 20.7.2002, p. 74).”
(*3) Commission Regulation (EC) No 792/2009 of 31 August 2009 laying down detailed rules for the Member States’ notification to the Commission of information and documents in implementation of the common organisation of the markets, the direct payments’ regime, the promotion of agricultural products and the regimes applicable to the outermost regions and the smaller Aegean islands (OJ L 228, 1.9.2009, p. 3).’”
(2)
In Article 24, paragraph 2 is replaced by the following:
‘2. Where a farmer declares a number of payment entitlements exceeding his total eligible area declared pursuant to Article 33(1) of Regulation (EU) No 1307/2013, the payment entitlement or the fraction of a payment entitlement which is partially exceeding that eligible area shall be deemed as fully activated for the purposes of Article 31(1)(b) of that Regulation. However, the payment shall be calculated on the basis of the corresponding fraction of an eligible hectare.’
(3)
Article 40 is amended as follows:
(a)
in the first subparagraph of paragraph 1, the following sentence is added:
‘That period may be fixed at national, regional or the appropriate sub-regional level.’;
(b)
in paragraph 3, the following fourth subparagraph is added:
‘Areas on which different crops are grown next to each other, where each single crop covers an area that is smaller than the minimum size set by Member States referred to in the second subparagraph of Article 72(1) of Regulation (EU) No 1306/2013, may be considered by Member States as covered with one ‘mixed crop’ as referred to in the third subparagraph of this paragraph.’
(4)
Article 45 is amended as follows:
(a)
paragraph 2 is replaced by the following:
‘2. On land lying fallow there shall be no agricultural production. Member States shall fix a period during which the land must be lying fallow in a given calendar year. That period shall not be shorter than 6 months. By way of derogation from Article 4(1)(h) of Regulation (EU) No 1307/2013, land lying fallow for the purpose of fulfilling the ecological focus area for more than 5 years shall remain arable land.’;
(b)
paragraphs 4 and 5 are replaced by the following:
‘4. Landscape features shall be at the disposal of the farmer and may be those that are protected under GAEC 7, SMR 2 or SMR 3 as referred to in Annex II to Regulation (EU) No 1306/2013 and/or one or more of the following features:
(a)
hedges, wooded strips or trees in line;
(b)
isolated trees;
(c)
field copses including trees, bushes or stones;
(d)
ponds. Reservoirs made of concrete or plastic shall not be considered ecological focus areas;
(e)
ditches, including open watercourses for the purpose of irrigation or drainage. Channels with walls of concrete shall not be considered ecological focus areas.
(f)
traditional stone walls.
Member States may decide to limit the selection of landscape features to those under GAEC 7, SMR 2 or SMR 3 as referred to in Annex II to Regulation (EU) No 1306/2013 and/or to one or more of points (a) to (f) of the first subparagraph.
For the hedges, wooded strips and trees in line as well as ditches referred to in points (a) and (e) of the first subparagraph, respectively, the area to be qualified as ecological focus area shall be calculated up to a maximum width of 10 metres.
For the field copses and ponds referred to in points (c) and (d) of the first subparagraph, respectively, the area to be qualified as ecological focus area shall be calculated up to a maximum size of 0,3 hectare.
For the purposes of point (d) of the first subparagraph, Member States may set a minimum size for ponds. Where there is a strip with riparian vegetation along the water the corresponding area shall be included for the purpose of calculating the ecological focus area. Member States may establish criteria to ensure that ponds are of natural value, taking into account the role that natural ponds play for the conservation of habitats and species.
For the purposes of point (f) of the first subparagraph, Member States shall establish minimum criteria based on national or regional specificities, including limits to the dimensions of height and width.
5. Buffer strips and field margins may be any buffer strips and field margins including those buffer strips along water courses required under GAEC 1, SMR 1 or SMR 10 as referred to in Annex II to Regulation (EU) No 1306/2013 or field margins protected under GAEC 7, SMR 2 or SMR 3 as referred to in that Annex.
Member States shall not limit the selection of buffer strips and field margins to those required under the cross compliance rules referred to in the first subparagraph.
Member States shall establish the minimum width of buffer strips and field margins which shall not be below 1 metre for ecological focus area purposes. Along water courses, riparian vegetation shall be included for the purpose of calculating the ecological focus area. There shall be no agricultural production on buffer strips and field margins.
For buffer strips and field margins other than those required or protected under GAEC 1, GAEC 7, SMR 1, SMR 2, SMR 3 or SMR 10 as referred to in Annex II to Regulation (EU) No 1306/2013, the area to be qualified as ecological focus area shall be calculated up to a maximum width of 20 metres.’;
(c)
the following paragraph 5a is inserted:
‘5a. For the purposes of the second sentence of the second subparagraph of Article 46(2) of Regulation (EU) No 1307/2013, areas referred to in paragraphs 4 and 5 of this Article shall be considered as adjacent areas or features where they are adjacent to an ecological focus area directly adjacent to the arable land of the holding.’;
(d)
paragraphs 7 to 10 are replaced by the following:
‘7. As regards strips of eligible hectares along forest edges Member States may decide either to allow agricultural production or to establish a requirement of no agricultural production, or to provide the two options for farmers. Member States shall establish the minimum width of those strips, which shall not be below 1 metre.
The area to be qualified as ecological focus area shall be calculated up to a maximum width of 10 metres where Member States decide to allow agricultural production and 20 metres where Member States decide not to allow agricultural production.
8. For areas with short rotation coppice with no use of mineral fertiliser and/or plant protection products, Member States shall establish a list of species that may be used for this purpose, by selecting from the list established pursuant to Article 4(2)(c) of Regulation (EU) No 1307/2013 the species that are most suitable from an ecological perspective, thereby excluding species that are clearly not indigenous. Member States shall also establish the requirements as regards the use of mineral fertilisers and/or plant protection products in case Member States authorise their use, keeping in mind the objective of ecological focus areas in particular to safeguard and improve biodiversity.
9. Areas under catch crops or green cover shall include such areas established pursuant to the requirements under SMR 1 as referred to in Annex II to Regulation (EU) No 1306/2013 as well as other areas under catch crops or green cover, on the condition that they were established by sowing a mixture of crop species or by under-sowing grass or leguminous crops in the main crop.
Member States shall set up the list of mixtures of crop species to be used and fix the period at national, regional, sub-regional or farm level during which areas under catch crops or green cover when established by sowing a mixture of crop species have to be in place. This period shall not be less than 8 weeks. Member States may establish additional conditions notably with regard to production methods.
Areas under catch crops or green cover shall not include areas under winter crops which are sown in autumn normally for harvesting or for grazing. They shall also not include the areas covered with equivalent practices mentioned in points I.3 and 4 of Annex IX to Regulation (EU) No 1307/2013.
10. On areas with nitrogen-fixing crops, farmers shall grow those nitrogen-fixing crops which are included in a list established by the Member State. That list shall contain the nitrogen-fixing crops that the Member State considers as contributing to the objective of improving biodiversity and may include mixtures of nitrogen-fixing crops with other crops provided that nitrogen-fixing crop species are predominant. Those crops shall be present during the growing season. Member States may establish additional conditions notably with regard to production method, in particular with a view to taking into account the need to meet the objectives of Directive 91/676/EEC and Directive 2000/60/EC, given the potential of nitrogen-fixing crops to increase the risk of nitrogen leaching in the autumn.
Areas with nitrogen-fixing crops shall not include the areas covered with equivalent practices mentioned in points I.3 and 4 of Annex IX to Regulation (EU) No 1307/2013.’;
(e)
the following paragraphs 10a, 10b and 10c are inserted:
‘10a. For the purposes of paragraphs 2, 5 and 7, “no agricultural production” means no agricultural activity as defined in Article 4(1)(c)(i) of Regulation (EU) No 1307/2013, without prejudice to the requirements defined under GAEC 4 as referred to in Annex II to Regulation (EU) No 1306/2013. Actions aiming at establishing a green soil cover for biodiversity purposes, including sowing mixtures of wild flower seeds, shall be allowed.
However, by way of derogation from the “no production” requirement, for the purposes of paragraphs 5 and 7, Member States may allow cutting or grazing on buffer strips and field margins as well as on strips of eligible hectares along forest edges without production, provided that the strip remains distinguishable from adjacent agricultural land.
10b. The use of plant protection products shall be prohibited on all areas referred to in paragraphs 2, 9 and 10 as well as on areas with agricultural production referred to in paragraph 7.
10c. On areas referred to in paragraph 9 established by under-sowing grass or leguminous crops in the main crop, this prohibition shall apply from the moment of the harvesting of the main crop for at least 8 weeks or until the sowing of the next main crop.’
(5)
In Article 49(3), the following subparagraph is added:
‘A young farmer who exercises effective and long-term control over the legal person within the meaning of point (b) of the first subparagraph of paragraph 1 of this Article shall, for the purposes of Article 50(2)(b) of Regulation (EU) No 1307/2013, be no more than 40 years of age in the year of the first submission of an application under the basic payment scheme or the single area payment scheme by that legal person with a young farmer in control.’
(6)
In Article 53(2), the second subparagraph is replaced by the following:
‘The annual payment shall be expressed as the per unit amount of support. It may be either one of the following amounts, or, when the area or the number of animals eligible for the support does not exceed the area or the number of animals fixed as referred to in the first subparagraph of this paragraph, an amount between them:
(a)
the ratio between the amount fixed for the financing of the measure as notified according to point (3)(i) of Annex I to this Regulation and the area or the number of animals eligible for the support in the year in question;
(b)
the ratio between the amount fixed for the financing of the measure as notified according to point (3)(i) of Annex I to this Regulation and the area or the number of animals fixed as referred to in the first subparagraph of this paragraph.’
(7)
In Article 64, paragraph 5 is deleted.
(8)
Article 65(1) is amended as follows:
(a)
point (c) is amended as follows:
(i)
point (ii) is replaced by the following:
‘(ii)
the total number of farmers exempted from one or more greening practices and the number of hectares declared by such farmers, the number of farmers exempted from all practices because they comply with the requirements of Regulation (EC) No 834/2007, the number of farmers participating in the small farmer scheme, the number of farmers exempted from the crop diversification obligation, and the number of farmers exempted from the ecological focus area obligation, and the respective number of hectares declared by such farmers;’;
(ii)
point (vi) is replaced by the following:
‘(vi)
the total number of farmers declaring environmentally sensitive permanent grassland, the total number of hectares covered by environmentally sensitive permanent grassland declared by such farmers, the total number of hectares of designated environmentally sensitive permanent grasslands and the total number of hectares of permanent grassland in areas covered by Directives 92/43/EEC or 2009/147/EC;’;
(b)
the following point (e) is added:
‘(e)
by 1 August of each year, the period to be taken into account for the calculation of the shares of different crops in accordance with Article 40(1) of this Regulation, as well as the geographical level at which that period is fixed.’
(9)
In Article 67, paragraph 2 is deleted.
(10)
Annex III is added, the text of which is set out in Annex I to this Regulation.
Article 2
Amendment of Regulation (EU) No 1307/2013
Annex X to Regulation (EU) No 1307/2013 is replaced by the text set out in Annex II to this Regulation.
Article 3
Transitional measures
1. By way of derogation from the second paragraph of Article 4, Member States may decide to apply some or all of the amendments made by points (3), (4) and (8) of Article 1 and, as a consequence, the amendment made by Article 2 in relation to standard ecological focus area features, with respect to aid applications relating to calendar year 2017.
2. Member States shall notify the Commission and shall inform farmers of the decision referred to in paragraph 1 and of the consequential changes to the notifications made pursuant to Article 65(1) to (4) of Delegated Regulation (EU) No 639/2014 no later than 1 month after the entry into force of this Regulation.
Article 4
Entry into force and application
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
Points (3), (4), and (8) of Article 1 and Article 2 shall apply with respect to aid applications relating to calendar years starting as from 1 January 2018.
Points (5) and (6) of Article 1 shall apply with respect to aid applications relating to calendar years subsequent to calendar year 2014.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 15 February 2017.
For the Commission
The President
Jean-Claude JUNCKER
(1) OJ L 347, 20.12.2013, p. 608.
(2) Commission Delegated Regulation (EU) No 639/2014 of 11 March 2014 supplementing Regulation (EU) No 1307/2013 of the European Parliament and of the Council establishing rules for direct payments to farmers under support schemes within the framework of the common agricultural policy and amending Annex X to that Regulation (OJ L 181, 20.6.2014, p. 1).
(3) Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants (OJ L 193, 20.7.2002, p. 74).
(4) Commission Implementing Regulation (EU) No 809/2014 of 17 July 2014 laying down rules for the application of Regulation (EU) No 1306/2013 of the European Parliament and of the Council with regard to the integrated administration and control system, rural development measures and cross compliance (OJ L 227, 31.7.2014, p. 69).
(5) COM(2015) 478 final, Report from the Commission to the European Parliament and the Council — The Mid Term review of the EU Biodiversity Strategy to 2020.
(6) Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 (OJ L 347, 20.12.2013, p. 549).
(7) Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1).
(8) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).
(9) Commission Implementing Regulation (EU) No 908/2014 of 6 August 2014 laying down rules for the application of Regulation (EU) No 1306/2013 of the European Parliament and of the Council with regard to paying agencies and other bodies, financial management, clearance of accounts, rules on checks, securities and transparency (OJ L 255, 28.8.2014, p. 59).
ANNEX I

ANNEX III
Union method for the quantitative determination of the Δ9-tetrahydrocannabinol content in hemp varieties
1. Scope
The method set out in this Annex seeks to determine the Δ9-tetrahydrocannabinol (hereinafter referred to as THC) content of varieties of hemp (Cannabis sativa L.). As appropriate, the method involves applying procedure A or B as described in this Annex.
The method is based on the quantitative determination of THC by gas chromatography (GC) after extraction with a suitable solvent.
1.1. Procedure A
Procedure A shall be used for checks on the production of hemp as referred to in Article 32(6) of Regulation (EU) No 1307/2013 and Article 30(g) of Commission Implementing Regulation (EU) No 809/2014 (*1).
1.2. Procedure B
Procedure B shall be used in cases as referred to in Article 36(6) of Implementing Regulation (EU) No 809/2014.
2. Sampling
2.1. Samples
The samples shall be taken during the day following a systematic pattern to ensure that the sample is representative of the field, but excluding the edges of the crop.
2.1.1. Procedure A: in a standing crop of a given variety of hemp, a 30 cm part containing at least one female inflorescence of each plant selected shall be taken. Sampling shall be carried out during the period running from 20 days after the start of flowering to 10 days after the end of flowering.
Member States may authorise sampling to be carried out during the period from the start of flowering to 20 days after the start of flowering provided that, for each variety grown, other representative samples are taken in accordance with the first subparagraph during the period from 20 days after the start of flowering to 10 days after the end of flowering.
For hemp cultivated as catch crop, in the absence of female inflorescences, the top 30 cm of the plant stem shall be taken. In that case sampling shall be carried out just before the end of the vegetation period, once the leaves begin presenting the first signs of yellowing, however no later than the onset of a forecast period of frost.
2.1.2. Procedure B: in a standing crop of a given variety of hemp, the upper third of each plant selected shall be taken. Sampling shall be carried out during the 10 days following the end of flowering or, for hemp cultivated as catch crop, in the absence of female inflorescences, just before the end of the vegetation period, once the leaves begin presenting the first sign of yellowing, but no later than the onset of a forecast period of frost. In the case of dioecious varieties, only female plants shall be taken.
2.2. Sample size
Procedure A: the sample shall comprise parts of 50 plants per field.
Procedure B: the sample shall comprise parts of 200 plants per field.
Each sample shall be placed in a fabric or paper bag, without crushing it, and be sent to the laboratory for analysis.
The Member State may provide for a second sample to be collected for counteranalysis, if required, to be kept either by the producer or by the body responsible for the analysis.
2.3. Drying and storage of the sample
Drying of the samples shall begin as soon as possible and, in any case, within 48 hours using any method below 70 °C.
Samples shall be dried to a constant weight and to a moisture content of between 8 % and 13 %.
After drying, the samples shall be stored without crushing them at below 25 °C in a dark place.
3. Determination of THC content
3.1. Preparation of the test sample
Stems and seeds over 2 mm in size shall be removed from the dried samples.
The dried samples shall be grinded to obtain a semi-fine powder (passing through a 1 mm mesh sieve).
The powder may be stored for 10 weeks at below 25 °C in a dark, dry place.
3.2. Reagents and extraction solution
Reagents

Δ9-tetrahydrocannabinol, pure for chromatographic purposes,

squalane, pure for chromatographic purposes, as an internal standard.
Extraction solution

35 mg of squalane per 100 ml hexane.
3.3. Extraction of THC
100 mg of the powdered test sample shall be weighed, be placed in a centrifuge tube and 5 ml of extraction solution shall be added containing the internal standard.
The sample shall be placed in an ultrasound bath and be left for 20 minutes. It shall be centrifuged for 5 minutes at 3 000 r.p.m. and then the supernatant THC solution shall be removed. The solution shall be injected into the chromatograph and a quantitative analysis shall be carried out.
3.4. Gas chromatography
(a) Apparatus

gas chromatograph with a flame ionisation detector and a split/splitless injector,

column allowing good separation of cannabinoids, for example a glass capillary column 25 m long and 0,22 mm in diameter impregnated with a 5 % non-polar phenyl-methyl-siloxane phase.
(b) Calibration ranges
At least three points for procedure A and five points for procedure B, including points 0,04 and 0,50 mg/ml THC in extraction solution.
(c) Experimental conditions
The following conditions are given as an example for the column referred to in (a):

oven temperature 260 °C,

injector temperature 300 °C,

detector temperature 300 °C.
(d) Volume injected: 1 μl.
4. Results
The findings shall be expressed to two decimal places in grams of THC per 100 grams of analytical sample dried to constant weight. A tolerance of 0,03 g per 100 g shall apply.

Procedure A: one determination per test sample.
However, where the result obtained is above the limit laid down in Article 32(6) of Regulation (EU) No 1307/2013, a second determination shall be carried out per analysis sample and the mean value of the two determinations shall be taken as the result.

Procedure B: the result shall correspond to the mean value of two determinations per test sample.

ANNEX II

ANNEX X
Conversion and weighting factors referred to in Article 46(3)
Features
Conversion factor
(m/tree to m2)
Weighting factor
Ecological focus area
(if both factors are applied)
Land lying fallow (per 1 m2)
n.a.
1
1 m2
Terraces (per 1 m)
2
1
2 m2
Landscape features:

Hedges/wooded strips/trees in line (per 1 m)
5
2
10 m2

Isolated tree (per tree)
20
1,5
30 m2

Field copses (per 1 m2)
n.a.
1,5
1,5 m2

Ponds (per 1 m2)
n.a.
1,5
1,5 m2

Ditches (per 1 m)
5
2
10 m2

Traditional stone walls (per 1 m)
1
1
1 m2

Other features not listed above but protected under GAEC7, SMR 2 or SMR 3 (per 1 m2)
n.a.
1
1 m2
Buffer strips and field margins (per 1 m)
6
1,5
9 m2
Hectares of agro-forestry (per 1 m2)
n.a.
1
1 m2
Strips of eligible hectares along forest edges (per 1 m)

Without production
6
1,5
9 m2
With production
6
0,3
1,8 m2
Areas with short rotation coppice (per 1 m2)
n.a.
0,3
0,3 m2
Afforested areas as referred to in Article 32(2)(b)(ii) (per 1 m2)
n.a.
1
1 m2
Areas with catch crops or green cover (per 1 m2)
n.a.
0,3
0,3 m2
Areas with nitrogen-fixing crops (per 1 m2)
n.a.
0,7
0,7 m2
Conversion and weighting factors referred to in Article 46(3) to be applied to features included in the equivalent practices as listed in Section III of Annex IX
Equivalent ecological focus area
Similar standard ecological focus area
Conversion factor
Weighting factor
Ecological focus area (if both factors are applied)
(1)
Ecological set-aside (per 1 m2)
Land lying fallow
n.a.
1
1 m2
(2)
Creation of “buffer zones” (per 1 m)
Buffer strips and field margins
6
1,5
9 m2
(3)
Management of uncultivated buffer strips and field margins (per 1 m)
Buffer strips and field margins
6
1,5
9 m2
(4)
Borders, in-field strips and patches:

Borders, in-field strips (per 1 m)
Buffer strips and field margins
6
1,5
9 m2
Patches (per 1 m2)
Field copses
n.a.
1,5
1,5 m2
(5)
Management of landscape features:

Isolated tree (per tree)
Isolated tree
20
1,5
30 m2
Trees in line (per 1 m)
Hedges/wooded strips/trees in line
5
2
10 m2
Group of trees/Field copses (per 1 m2)
Field copses
n.a.
1,5
1,5 m2
Hedgerows (per 1m)
Hedges/wooded strips/trees in line
5
2
10 m2
Riparian woody vegetation (per 1m)
Hedges/wooded strips/trees in line
5
2
10 m2
Terraces (per 1m)
Terraces
2
1
2 m2
Stone walls (per 1m)
Traditional stone walls
1
1
1 m2
Ditches (per 1m)
Ditches
5
2
10 m2
Ponds (per 1 m2)
Ponds
n.a.
1,5
1,5 m2
(6)
Keeping arable peaty or wet soils under grass (no use of fertilisers and no use of plant protection products) (per 1 m2)
Land lying fallow
n.a.
1
1 m2
(7)
Production on arable land with no use of fertiliser and/or plant protection products, and not irrigated, not sown with the same crop two years in a row (per 1 m2)
Areas with short rotation coppice; Strips along forest edges with production; Areas with nitrogen-fixing crops
n.a.
0,3
0,7 for nitrogen-fixing crops
0,3 m2
0,7 m2
(8)
Conversion of arable land into permanent grassland (per 1 m2)
Land lying fallow
n.a.
1
1 m2


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The chairman of the German Association for Cannabis as Medicine Dr. Franjo Grotenherman, has entered an “indefinite” hunger strike until Germany “decriminalize all citizens who need cannabis to treat their serious diseases.”

On August 17, 2017, I entered an indefinite hunger strike. The objective of refusing to accept any food is to decriminalize all citizens who need cannabis to treat their serious diseases.

On March 10, 2017, a much-debated law on cannabis as a medicine went into effect in Germany. It was the declared aim of the legislature to allow all patients who need a therapy with cannabis medicines to do so. The law, however, proves itself in practice as bureaucratic. Therefore, a treatment with cannabis and cannabinoids is unattractive for doctors who in principle support such therapy. Many patients do not find a doctor who allows them legal access to the needed treatment.

The legislator has taken a great step into the right direction. However, many patients are still dependent on a still as illegal regarded treatment. They face criminal sanctions. This is no longer acceptable. Therefore a basic clarification in the narcotics law must be established. The prosecution of patients to whom a doctor has certified the need for a therapy with cannabis must end.

Already today, the German Narcotics Law allows prosecutors to stop a criminal case in the case of a „minor debt“. This possibility is mainly applied in cases of possession of small amounts of cannabis. I urge that criminal proceedings should in principle also be stopped if accused citizens need cannabis for medical reasons. The need for a cannabis therapy should not be judged by the judiciary, a government agency or a health insurance company, but, as with other medical treatments, also by a doctor.

I also strongly support the uncomplicated access of patients to standardized preparations from the pharmacy. In this respect, it is necessary to improve the existing law. However, the prosecution of the remaining losers of the legal situation must also be ended. I am not aware of a convincing argument by which patients‘ prosecution can be maintained. A corresponding amendment to the Narcotics Act is, therefore, logical and unavoidable.

Franjo Grotenhermen, born in 1957, studied medicine in Cologne. Medical practice in Rüthen (NRW) with a focus on therapy with cannabis and cannabinoids. Grotenhermen is the chairman of the German Association for Cannabis as Medicine (ACM), Executive Director of the International Association for Cannabinoid Medicines (IACM) and Chairman of the Medical Cannabis Declaration (MCD), as well as author of the IACM-Bulletin, which is available in several languages ​​on the website of the IACM. Grotenhermen is an associate of the Cologne nova-Institut in the department of renewable resources and author of numerous articles and books on the therapeutic potential of cannabis and cannabinoids, their pharmaco logy and toxicology. Among others, since 2008 he has been an expert on debates in the Health Committee of the German Bundestag on the medical use of cannabis products, most recently in September 2016.

franjo


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Canada’s medical marijuana market has experienced explosive growth, particularly for extracts. The amount of cannabis oil sold to clients registered with Health Canada rose 870% between the first quarter of 2016, when 584 kilograms were sold, and one year later, when 5,673 kilograms were sold.

Canada-recreational-marijuana-web-e1501023238758

 

http://www.cenedella.de


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ALGAE DYNAMICS CORP ENTERS INTO A LETTER OF INTENT WITH BONIFY TO PRODUCE UNIQUE CANNABIS OIL PRODUCTS; ACCELERATES GO-TO-MARKET STRATEGY

RADINZ_LAYOUT

 

 

ALGAE DYNAMICS CORP ENTERS INTO A LETTER OF INTENT
WITH BONIFY TO PRODUCE UNIQUE CANNABIS OIL PRODUCTS;
ACCELERATES GO-TO-MARKET STRATEGY

TORONTO--August 16, 2017--ALGAE DYNAMICS CORP (OTCQB: ADYNF) (the "Company"), a
company focused on the development of unique health products and pharmaceuticals utilizing cannabis
and algae oils, today announced that it has further refined its relationship with 6779264 Manitoba Ltd dba
Bonify (“Bonify”) in a Letter of Intent (“LOI”) dated August 10, 2017. Bonify is a Licensed Producer,
pursuant to the Access to Cannabis for Medical Purposes Regulations in Canada, with the capability to
grow multiple strains of cannabis in its state-of-the-art 320,000 square foot facility.
The Company previously announced a Memorandum of Understanding with Bonify on May 9, 2017, in
which Bonify agreed to supply raw cannabis plant material for processing into cannabis oil for sale and
for use in research. In the recently completed LOI, the Company and Bonify have outlined the following:
1) The purchase and installation of cannabis oil extraction equipment by the Company in Bonify’s
facility;
2) The processing of cannabis material supplied by Bonify and other Licensed Producers in the oil
extraction facility;
3) The supply of cannabis oil and algae omega-3 oils to The University of Waterloo and University of
Western Ontario to support the Sponsored Research Agreements that the Company has in place with
the two universities; and
4) The sharing of direct expenses, and, after adjustment for the market value of cannabis material
supplied by Bonify and third parties, sharing of revenues from the sale of cannabis oil and algaecannabis
oil products.
The term of the agreement is for three years from the commencement of operations and is renewable by
mutual agreement. The Company and Bonify agree to use best efforts to complete formal documentation of
the agreement by September 30, 2017. Upon termination of the agreement, the Company agrees to transfer
title of the equipment to Bonify. The Company has engaged investment bankers to assist with the raising of
necessary capital to purchase and install the extraction equipment.
Given the favorable terms of this agreement, the Company does not anticipate moving forward with its
previously announced joint venture with ARA – Avanti Rx Analytics Inc. in which it was contemplated that
oil extraction would be done utilizing the latter’s facility.
Assuming that all regulatory approvals are in place, initial revenues are expected within six to nine months
following completion of financing,
Paul Ramsay, Chairman and President of Algae Dynamics Corp, stated, “We believe this Letter of Intent
gives us an improved pathway to early revenues as well as a reliable high-quality source of cannabis oil for
the universities to support our important algae-cannabis oil research. We look forward to expeditiously
completing this agreement.”
Jeff Peitsch, President and CEO of Bonify, commented, “Our team is pleased to be working with Algae
Dynamics Corp in support of the Company’s ongoing research and product development work with
universities. We see many benefits to working together with innovative companies such as Algae Dynamics
in this burgeoning cannabis market.”
About Bonify
Bonify is a Canadian-owned Licensed Producer and leading provider of medical cannabis. By maximizing
research findings and strictly adhering to best-in-class practices, quality standards and procedures, Bonify
produces medical cannabis products to help individuals get the most out of life each and every day. With
over 1,000,000 square feet of potential productive capacity at its present site in Winnipeg, Manitoba, Canada,
when at full scale, Bonify will be capable of growing over 100,000 kgs of cannabis annually.
About Algae Dynamics Corp
ADC is engaged in the development of unique health products and pharmaceuticals that utilize hemp,
cannabis and algae oils. We have engaged two Canadian universities to provide research into the use of
extracts from cannabis oil, which we plan to use to develop products that combine the significant health
benefits of Omega-3s derived from algae oil and extracts from cannabis oil. Our research is focused on the
use of cannabis oil in the context of cancer, and the use of cannabis derivatives for the development of novel
pharmacotherapies for mental health.
For more information, visit http://www.algaedynamics.com
FORWARD-LOOKING STATEMENTS
This news release contains "forward-looking statements" as that term is defined in Section 27A of the
Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended. Statements in this press
release which are not purely historical are forward-looking statements and include any statements regarding
beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include,
among other things, use of proceeds and the development, costs and results of current or future actions and
opportunitiesin the sector. Actual results could differfrom those projected in any forward-looking statements
due to numerous factors. Such factors include, among others, the inherent uncertainties associated with new
projects and development stage companies, our ability to raise the additional funding we will need to
continue to pursue our exploration and development program, and our ability to retain important members
of our management team and attract other qualified personnel. These forward-looking statements are made
as of the date of this news release, and we assume no obligation to update the forward-looking statements, or
to update the reasons why actual results could differ from those projected in the forward-looking statements.
Although we believe that any beliefs, plans, expectations and intentions contained in this press release are
reasonable, there can be no assurance that any such beliefs, plans, expectations or intentions will prove
to be accurate.
Investors should consult all the information set forth herein and should also refer to the risk factors disclosure
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Cannabis And The Elderly: A Neurophysiological And Pharmacological Review

by Gaurav Dubey

The elderly population, a term which is generally agreed to mean any individual age 65 or older, is a uniquely diverse and often complex demographic to treat

The aging baby boomers now include many frail and elderly individuals, as Knickman and Snell put in their 2002 review discussing, among several items, “the potential burden an aging society will place on the care-giving system and public finances” (Knickman & Snell, 2002).

Devastating neurodegenerative illnesses such as Alzheimer’s Disease and Parkinson’s disease, as well illnesses such as cancer and chronic pain are more prevalent in older populations and require a multimodal treatment approach. Such treatment can involve hospice care when patients are diagnosed as “prospectively dying” and are the often given very high doses of narcotics, such as morphine, to help ease this pain (Ber-sala et al., 2013) (Scitovsky, 2005).

However these powerful comfort drugs carry serious side effects that can be incredibly detrimental to one’s quality of life (Meier, 20111). A study by Ber-sala and colleagues, however, is one among several emerging studies that also indicate significant alleviation of symptoms in the elderly upon cannabis consumption (Ber-sala et al., 2013). I have discussed previously works that clearly demonstrate the efficacy of cannabis in the treatment of various disorders such as Alzheimer’s and Chronic Pain, conditions with a high prevalence in the elderly population. To this end, this article will focus on a new 2017 study by Katz and colleagues that demonstrably shows the utility and efficacy of cannabinoids in the elderly while using other related and supporting data (Katz et al., 2017). Providing safe, effective and therapeutic care for our senior citizens and adequate end of life care for hospice patients is the hallmark of a successful healthcare system and compassionate society. As such, further investigation into cannabis and cannabinoids for the elderly population is a vital responsibility for the medical community and it’s healthcare providers.

The elderly population, which is steadily increasing in numbers, is the demographic with the highest prevalence of disease and suffering (Parker et al., 1997). The need for adequate care and allocation of resources to treat this diverse population presenting with an even more diverse palette of pathologies is a critical one. Elderly patients typically consume a large amount of prescription drugs, all with varying risk and side effect profiles (Katz et al., 2017).

“Comfort Drugs” used in hospice care, such as hydrocodone, morphine and fentanyl, while generally effective at treating pain, can cause significant drowsiness and even respiratory depression, leading to death, upon overdose (Chau et al., 2008). Chau’s study also describes how normal physiologic aging can significantly alter the pharmacokinetic mechanisms of such drugs in the elderly population, which requires even greater care by the prescribing physician (Chau et al., 2008). With the mounting clinical evidence regarding the efficacy of cannabis to treat a wide variety of pathologies, including many that significantly affect the senior population, special attention should be given to the potential of adding cannabis to the arsenal of drugs to help treat the elderly.

When used simultaneously with opioids, “cannabinoids have been shown to successfully lead to a greater cumulative relief of pain” leading to patients using fewer opiods and experiencing fewer side effects (ref). Perhaps more fascinating from a neuropharmacological standpoint is the fact that cannabinoids seemed to also “prevent the development of tolerance to and withdrawal from opiates” and is even able to essentially cause a weaker dose, that wasn’t working as efficaciously for pain relief for the patient before, to become effective once again (Lucas, 2012). The reduced side effect and high safety profile both present cannabis as a compelling alternative or adjunct to these drugs as well.

In a new 2017 review analyzing clinical evidence for the utilization of cannabinoids in the elderly by Katz and colleagues, the beneficial effects of cannabis in the elderly is implicated by just some of the major conditions cannabis is known to effectively treat in the elderly: Dementia, Parkinson’s Disease, Alzheimer’s Disease and Cancer (Katz et al., 2017).

pensioner cannabis

Image credit- Mass Roots

Furthermore, in discussing the safety of cannabis, Katz and colleagues state, “Cannabinoids present a relatively safe profile of action in elderly patients. Hence, cannabinoid treatment should be considered more readily when other options fail, even in cases of scarce data” (Katz et al., 2017). In fact, I strongly believe that due to the relative safety of cannabis (no reported overdoses/deaths), it should often be considered a first line treatment if possible, over the use of an opioid analgesic, for instance, which carries significantly greater risks. In a population that is often already overmedicated, the possibility of using cannabis, a compound known to be relatively safer than some of the other drugs used to treat chronic pain and illness, should be seriously considered as a mainstay treatment as more data becomes available (Katz et al., 2017).

Indeed, my article regarding cannabis use reducing the individual consumption of prescription drugs speaks to this point well.

As mentioned above, cannabis has been identified to have beneficial and therapeutic properties for several diseases with high prevalence in the elderly. One such condition that cannabis has been indicated for is Alzheimer’s Disease (AD). Indeed, Volicer et al. demonstrated in a placebo-controlled crossover-designed study that treatment with a THC analogue (Dronabinol) attenuated behavioral disturbance in Alzheimer’s patients (Volicer et al., 1997).

While critics of this study claim the lack of quantitative data make the results difficult to adequately validate, a systematic review by Woodward and authors, reporting on “the largest studied cohort of dementia patients treated with Dronabinol to date”, was able to confirm these findings. They reported that Dronabinol could serve as an efficacious “adjunctive treatment for neuropsychiatric symptoms in dementia” (Woodward et al., 2014).

Furthermore, Katz and colleagues, in reviewing this clinical data, concluded that cannabinoids seem to be a safe and effective treatment for therapy “to manage behavioral disturbances in patients” (Katz et al., 2017). Neurodegenerative disorders such as AD are debilitating and often require a multidimensional approach to treatment. Similar challenges arise when considering Parkinson’s disease, another common neurodegenerative illness prevalent in the elderly.

Parkinson’s Disease (PD) is another illness commonly associated with elderly patients and is primarily characterized by death of dopamine neurons in the substantia nigra. It often presents with symptoms such as: tremor, rigidity, gait abnormality and non-motor related clinical symptomology (Katz et al., 2017).

While the etiology of PD is still largely unknown, emerging research has uncovered that our own endocannabinoid system seems to play a significant role in the mechanism of the illness (Katz et al., 2017). This is pharmacologically fascinating as there is a lack of CB1 receptors (one of two main cannabinoid receptors in the body/brain) in the dopaminergic nigostriatal (this is spelt correctly?) neurons that are being damaged due to this serious illness.

canada cannabis

It’s currently presumed this occurs due to the fact that the endocannabinoid system modulates GABA and glutamate transmission (two other major neurotransmitter systems in the brain not part of the endocannabinoid system) (Katz et al., 2017). The ability of our own intrinsic endocannabinoid system to play a key role in the mechanisms of this disease holds promise for the future treatment of PD with cannabis.

A common feature of both PD and AD along with other neurodegenerative disorders prevalent in the elderly is dementia, a debilitating phenomenon that has shown significant receptivity to the therapeutic applications of cannabis (Walther & Halpern, 2010). In regards to PD, cannabis has been shown to provide “significant amelioration also in rigidity, tremor, bradykinesia, pain and sleeping problems with no significant adverse effect” (Lotan et al., 2014). Furthermore, a small cohort of 22 PD patients treated with cannabis and surveyed 30 minutes after use reported “a significant improvement of 9.9 points in the mean score Unified Parkinson’s Disease Rating Scale (P<0.0001)” (Katz et al., 2017).

Another common morbidity and co-morbidity among the elderly population is cancer. Chemotherapy is a common mainstay of cancer treatment and is well known to carry seriously averse side effects that are difficult to manage for patients. A recent 2016 review by Dr. Abrams states “Cannabis is useful in combatting anorexia, chemotherapy-induced nausea and vomiting, pain, insomnia, and depression” induced by chemotherapy (Abrams et al., 2016).

In a study with 211 patients, of which 131 had a second, follow-up interview, “all cancer or anticancer treatment-related symptoms showed significant improvement (P < 0.001). Aside from memory lessening in patients with prolonged cannabis use, “no significant adverse events” were reported (Ber-sala et al., 2013). Having worked in an oncology ward for 4 summers and in my training as an EMT in Miami-Dade, I’ve personally witnessed the immense suffering of cancer patients. It’s difficult not to want to provide anything and everything to assist them, especially if they are in their final years and moments before the inevitable. Narcotics such as morphine for pain and adderall to combat the drowsiness from the morphine are common balancing acts in regards to hospice care medications.

As stated by Nersesyan & Slavin, “Stimulants such as methylphenidate or caffeine can increase alertness in patients who are experiencing somnolence on a dose of morphine that provides sufficient pain control” (Nersesyan & Slavin, 1998). With cannabis having a significantly lower side effect profile and a lower chance of adverse drug events as mentioned above, it is time to seriously consider easy access of cannabis to elderly patients suffering from these conditions, especially those in hospice care. Perhaps the pharmacokinetic mechanisms of the drug are not completely understood, however, enough compelling data exists, combined with the fact there has never been one singlepurported overdose/fatality from cannabis that serious consideration need be given to this modality of treatment.

cannabis weight loss

The safety profile of cannabis next to some of the other drugs used to treat this patient population isn’t even comparable when considering potential for fatalities (that already occur every day) from opioids alone. For this and so many other reasons, it’s time to make a change.

So why restrict access to cannabis if it is beneficial for elderly and it improves their quality of life? Ber-sala, in his study, states that cannabis induced relief of symptoms in their study may in part be due to its euphoriant properties. He points out that, “from a medical point of view, the general improvement in the level of distress is important as an end-point for palliative studies, and the cause is less important (Ber-sala et al., 2013).

There is no doubt that the use of potent narcotics such as morphine and hydromorphine create powerful and potentially addicting “highs” as well, but their use is often times warranted in this situation. Thus, holding cannabis to a different standard due to this side effect is in fact holding a double standard and disrespecting science and evidence. In fact, if you’re sick and dying of cancer on your deathbed, the idea of “feeling good” is a powerful one I think many people, especially those in the medical profession, can relate with.

Another reference in regards to cannabis in popular culture is the “munchies”, essentially, the appetite-stimulation effects of cannabis use. While the data is scarce on this topic in the elderly, preliminary findings show promise (Katz et al., 2017). A few small studies (<40 people) using Dronabinol as a treatment found small changes in weight gain or increased consumption of food over shorter time intervals (Katz et al., 2017). Furtherore, when considering the “entourage effect” (define that) and the beneficial effects of, for instance, Sativex (a 1:1 THC:CBD ratio, whole plant cannabis formulation) over other synthetic cannabinoid compounds such as Dronabinol and Marinol, it begs the question about whether whole plant cannabis formulations would be even more beneficial to patients over synthetics compounds (Russo, 2008).These results call for further investigation as proper nutrition is vital to this population of patients.

The stigmatization of the “high” of cannabis and the social satire of the “muchies” can often detract from the medical necessities of these effects for cancer patients, many of whom report as truly depending on these characteristics of cannabis to help them through such illnesses (Waissengrin et al., 2015). Overwhelming data shows this population could potentially benefit greatly from cannabis use and only more research and more science can help change public perception.

The elderly population is one that suffers from an increased prevalence of a variety of severe pathologies, not the least of which including neurodegenerative disorders, cancer and chronic pain. A recent 2016 study found that “medical expenses more than double between ages 70 and 90” and that “ the government pays for over 65 per cent of the elderly’s medical expenses” (De Nardi et al., 2016). If the effects of cannabis can be reproduced in bigger trials, FDA approved treatments and therapies that are efficacious and successful can be implemented, healthcare costs and the benefit to society overall could improve. With a healthcare crisis already underway in our country, perhaps a paradigm shift such as this one is a promising one. Maybe the question we should be asking is not “can we afford to do this?” but rather, “can we afford not to?”

[Featured image credit- Endoca]

Gaurav Dubey | August 15, 2017 at 1:14 pm | Tags: Cannabiscannabis elderlyCannabis studyMedical Cannabis studyPensioners | Categories: FeaturedHealth | URL: http://wp.me/p8nEcz-H9
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“It’s California in 1995 All Over Again, Man” – Opportunities and Problems Piling Up in the European Cannabis Market – from Cannabis Business Executive magazine / Philip J. Cenedella IV

“It’s California in 1995 all over again, man.”

That was a comment I overhead during a conversation between an American and a German entrepreneur at the Mary Jane Berlin event held in Berlin in the second week of June, 2017.

Indeed, there may not be a better way to sum up the current state of the state here in Europe’s most populous country. Having been on the frontlines of the grassroots efforts in San Diego last century, it is fun to see how our industry is now growing in Germany and throughout Europe.  And like California back then, or now, the struggle is not always easy.

Here’s another interesting quote of the month:

“European markets are increasingly important to the cannabis sector. Each has a well-funded medical system, residents who seek natural and complementary therapies, and a government-supported mandate to stop the rising tide of opiate addiction related to chronic pain treatment.”

-Benjamin Ward, CEO, Maricann Group, Inc.

As of August, 2017 starts, the medical marijuana patients in Germany are experiencing “sold out” conditions nationwide, and the two exclusive importing countries (Canada and the Netherlands) are anticipating further bottlenecks as their in-country supply needs change. This is a significant problem – but also an opportunity for GMP-certified growers to fill the gap. If, and how, the German government opens up alternative supply to support their medical patients will be the top story in Germany this year.

From the patients perspective, there are two bad things about the current state of affairs: Little to no choice in their required medicine and their insurance companies are now refusing to cover the costs for the medicine as stipulated in the federal law.

Of course, lawyers are now getting involved and insurance companies are starting to be forced into approving valid claims from their policy-paying customers. But it is a silly, slow process to say the least.

The solution the German government is pursuing is to award 10 grow licenses to companies that will then produce 200 lbs. cannabis ​each within the country. The first bud from those plants are not scheduled to be picked until sometime in 2019, which is simply too long for patients to wait.

Some of the companies that have been publicly mentioned as potential winners of a grow license are Spektrum Cannabis, which is the Canopy Growth company formerly known as MedCann; Maricann GmbH, which is the new German subsidiary of its Canadian parent, Bedrocan, that has been a leader in the industry but recently run into a dispute with their Canadian licensee, Bedrocan International; Aurora Cannabis from Canada, which recently acquired the German firm Pedianos adding an EU-wide, medical marijuana distribution capability; and ABCann of Canada, which touts the “Father of THC” Dr. Raphael Mechoulam as a key member of their board of directors.

Homegrow options in Germany are currently not permitted, and existing indoor/outdoor farm operations are not yet able to be registered, licensed and taxed.

The black market continues to win, and patients continue to lose.  Cannabis business executives worldwide need to effectively work with the German government to develop the solutions we all know exist.  Three organizations that are key to this effort are the BfArM (www.bfarm.de )  the DHV (www.hanfverband.de )  and the GTAI ( www.gtai.de )

My personal comment is the government, politicians and regulators here in Germany need to listen to their constituents who support our industry by over 60 percent nationwide, according to a recent poll. The total quantity of flower to be delivered by the 10 licensees is probably less than what my buddy Butch has in his building back in California to handle his patients which live within five miles of the office.

Yes I am joking, Butch usually has less, but the point is – ​it simply is not enough for a population twice the size of California.

With all the talk about Germany, it is also important to remember that it is one of 18 countries within Europe that currently allow for some form of medical marijuana.  Besides Germany, there are provisions for the distribution and use of medical products in Austria, Belgium, Czech Republic, Denmark, Finland, France, Greece, Israel, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and, the most recent addition, Poland.

This is an interesting list that, again, shows these are historic times here in Europe.

Sadly missing from the list above is the United Kingdom, and that has affected people we know. Our friend Vera Twomey, and her entire family had to leave the U.K. last month just to take care of their young daughter with Dravet’s Syndrome. In the U.K. their daughter suffered from up to 30 grand mal seizures a day while taking a regimen of pharmaceutical drugs.

Think about that for a moment – 30 grand mal ​seizures a day.

Now living as “medical refugees” from their homeland, the Twomey’s and their daughter are now dealing with zero grand mal seizures a day thanks to her medical marijuana.

30 grand mal seizures a day, now zero a day – everyday for the past 3-4 weeks.

The United Kingdom calls medical marijuana illegal. Patients and advocates call that thinking arcane, unjust, and possibly criminal itself. They are now petitioning the Human Rights Commission of the European Union in Brussels for help. I am positive their efforts will be successful – it is just a matter of time.

Vera and her family hope it comes within her daughter’s lifetime. That is all for now. Have a successful rest of the summer, rest up and get ready because I believe that Q-4 of 2017 is going to be a busy one for our industry and your company.

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