Pharmascience Inc. v. Meda AB et al - Nov 18, 2021 - Part 2

4:25PM Nov 18, 2021

Speakers:

Sean Prouse

JUSTICE ZINN

Keywords:

report

formulary

provinces

interchangeability

noc

alberta health

drug

fc

pharmacist

january

dispense

prince edward island

osi

exhibit

date

submission

product

paragraph

witness

designation

Check 123

Before we begin for transcription and recording purposes, Could everyone speak slowly and clearly, basically microphone and please remain on mute when you're not speaking. Thank you and the court has now resumed recording in progress

where is our witness?

Thank you. Sorry. No, you're still on mute. Thank you. Thank you Miss Baird.

Anything has to happen to at least one person every day or it's not a virtual trial. And be before the break. Mr. Sorry, I know you had you had confirmed buddy assurance and control our semi variable costs correct.

I think that from what I've heard, well, let me back up. My understanding before the evidence that I've heard since then, yesterday, to be precise, was that quality control and quality insurance assurance excuse me, was primarily a a very walk she was a semi variable cost just as you said, including both a fixed component and variable component. The variable component was the material is I understood it the materials used to to test the product and the fixed component was the equipment that is used to test the product.

And likewise, your opinion was that the manufacturing and packaging machine costs are semi variable

No, I thought that those were primarily fixed and were properly approached, treated as as such. Simply because the, the bulk of the expense is that comprise that amount. That total aggregate were fixed costs being depreciation, capital cost and space. I have since learned well Bruno to I forgotten his last name sorry. yesterday said that space is not part of that. Therefore the variable component, which is repairs and maintenance would be a bigger proportion than it was otherwise. And so now, I would perhaps slide that into a semi variable, which is a number between my number and Ms. Frederick's number.

Okay, so for both of those that are technically for items, quality assurance and control in the manufacturing and packaging machine, it's now your opinion that they are semi variable, so there would be some incremental cost.

It sounds like there's some what that is, whether it's 9010 or 5050. I don't know.

But to be clear, if if the court was to ask your your opinion, you'd say that those are semi variable costs and some amount should be deducted.

From what I've heard, yes.

Thank you, Mr. Sorry. No, those are all my questions.

Miss Mary, do you have any reexamination this distinct thing

I'm getting myself I know I do not justice. Thank you.

Thank you very much. Thank you, Mr. Soriano pretty sure on and off, thank you

know, just to sit I don't know and perhaps Mr. Geralt, he could join and let us know what the status of Mr. Makovski is and whether it would behoove us to take lunch now and or I don't know.

Thank you for saying so just as in we can email Mr. Makovski. We had or it might be around noon, but I think she's available now. So if we just take two or three minutes, I can email her get her into the chat room and I think I can have her direct done by the time we hit the lunch break, which I think he said was at some point before 1230 today

has to be just before 1230 Assuming they're on time i

i don't see if I can proceed problem having you're done by then.

Okay. Let's take a break and we'll just go off screen and you let us know when she's available. And we'll come back on

recording stopped So the witnesses in the waiting room Thank you are we ready? To begin?

Do we have someone from Blake's just so everyone knows I am off of the transcription service. Again, that was an issue I was having this morning. I don't think it's necessary. That I see it. Just so you know that I'm not getting the speed

we get someone from Blake's is going to cross this witness on screen please.

recording in progress.

Thank you Mr. Okay, let's bring the witness

in can you hear me?

Oh yes, I can hear you.

Can you please turn on your camera

and just thank you. There I am. Perfect. Thank

you very much. So can you please state your full name, occupation and professional address for the record?

name is Rosemary and bucho ski. I am a pharmacist and my address is 38/21 Street. Southwest Calgary Alberta. T two s one R three

and I see here that you would like to proceed by solemn affirmation, correct. You have your solemnly affirm that the evidence to be given by you to the court shall be the truth, the whole truth and nothing but the truth? Yes, thank you

Mr. Geraci.

Morning, Mr. mcklusky. Can you just confirm that you're alone in the room and have no documents in front of you, other than your report?

I am alone in the room and I have no documents in front of me, except my report.

Thank you. And can you briefly tell the court about your educational background?

I obtained my Bachelor of Science in Pharmacy at the University of Alberta in 1977. I took a master of pharmacy in 1985 and a Master's in Health Services Administration in 1997.

And where have you been employed during your career?

For the first 13 years I practiced in hospital pharmacy in the Edmonton area at the Cross Cancer Institute for 10 years living as the Acting Director of pharmacy, and then I was at the red water General Hospital as director of pharmacy. I then went on to work for Alberta Health for six years in various policy positions with my last year being director of pharmacy service.

What year was that that you left over to health

1996

And where have you been employed since leaving Alberta Health.

Since I left Alberta Health I set up a consulting company in which I provide customized service services to the pharmaceutical and healthcare industries.

And I also I understand you also do some writing in this area.

I write my report from 2002 to 2017. I will wrote a quarterly column for Provincial reimbursement advisor, which was a publication of IMS Health. During that time period I wrote 65 articles

and explain briefly to the court the exporter different provincial formularies.

My exposure to drug plans and their formularies across Canada started when I was taking my Masters in Health Service Administration I was approached by Alberta Health to do a review of their drug program. So as part of this review, I examined whoa drug programs across the country. After that during my various positions with in Alberta Health, I always included a cross Canada analysis of the drug being reviewed or the drug policy being studied. So my exposure to drug plans was from that research perspective. I also got to know drug plan managers throughout the country when I did my research.

Okay. Now I understand you've testified previously in the federal court. Yes, I have and what's been the subject matter of your testimony? What

I have said, I've testified in Section Eight issues.

Okay.

And I understand you prepared a report in this case dated July the fifth 2021. Correct. And I believe you mentioned you have a copy of that in front of you. Yes, I

do. Okay,

just as in I'll tell you how we propose to have Ms. Borkowski qualified and I understand my friends don't have any objection to this. It says Miss McCluskey Miss Rosemary Bukowski as a pharmaceutical industry consultant, and pharmacist with expertise in formulary listing. interchangeability designations market access reimbursement policies and pricing regimes of the Canadian pharmaceutical marketplace

and having read her CV and actually believe having ADGER appear in front of me previously been accepted as an expert. She's accepted, qualified as an expert in accordance with the statement you just made.

Thank you just a second. And then if I could just mark Misako skis report as an exhibit.

Yes, indeed. And what is the FC number?

That's FC one

that's reversed

and that will be exhibit 122.

Thank you. Now Mr. Borkowski. Can you just tell the court what your mandate was in preparing a report?

My mandate was or is outlined in paragraph three of my report. I was asked to determine whether and when farmers sciences, zolpidem product PMS are put in and whether and when it protects us. Zolpidem would have been designated as off formulary interchangeable anywhere in Canada. And I was asked to make this determination in one scenario that but for scenario was farmers science receiving a notice of compliance for PMS, zolpidem on January 2 2015, and a protects receiving its NOC for a pose OPA dam on December 31 2014. And that no other generic zolpidem products would enter the market before January 1 2019.

Thank you. Now what does drug interchangeability refer to?

Drug interchangeability is a designation given at the provincial level and covered by provincial legislation and policies, whereby one drug is considered to be pharmaceutically and bio pharmaceutically equivalent to bio equivalent to another product. This allows the two drugs to be interchanged according to the policy within that province, so pharmacist can generically substitute one for the other without contacting the prescriber for permission to do so.

And what does OSS formulary entertainers refer to?

This refers to a product that is not a benefit on a formulary, but the province so drug plan has essentially reviewed it and deemed it to be interchangeable with a brand name product.

And in the years 2015 to 2016 with provinces made a designation of all formulary interchangeability

for problems provinces did this Ontario, Nova Scotia Prince Edward Island in Newfoundland and Labrador.

And so if a patient went to a pharmacy in one of those provinces with a prescription that was written for a brand product in 2015 2016, and the designation of off formulary interchangeability was not yet made with the pharmacists have to dispense the brand.

No. The pharmacist could discuss the availability of a generic alternative with the patient and if the patient wanted the generic to be dispensed, the pharmacist would contact the prescriber to have the prescription altered so that the generic could be dispensed.

And then what is situations might that happen?

This could occur when the patient honor to reduce their out of pocket costs because directly dispense product is usually cheaper than the brand name product. So for since this wasn't a benefit under any of the provincial drug plans, it was either the patient paying totally out of pocket for the drug or a private sector drug plan. The private sector drug plan may have a policy in which the there's a requirement for as a patient to have the generic prescription dispensed rather than the brand name, prescription dispensed in order to pay a lower CO payment.

Now if a province does not designate a formulary interchangeability, what does that mean for dispensing?

It depends upon the province, for example, in British Columbia, and Quebec, the interchangeability is that the pharmacist professional judgment as to which product to dispense. Alberta has a similar concept for drugs that were not benefits on the provincial formulary, which in this case, includes OPA them in New Brunswick pharmacists could alter prescriptions under a prescriptive authority type of process in which they essentially use their professional judgment to dispense a generic product. And in Saskatchewan and Manitoba. Because there was no off formulary interchangeability, the pharmacist would have to contact the original prescriber in order to dispense a generic product. So the prescription would be changed accordingly.

And for

what circumstances would that happen?

The circumstances would be a game whereby the pharmacist would advise the patient that the there was a generic alternative and see what the patient wants to dispense the generic product or brand product, and if it was generic, the pharmacist would contact the prescriber to have the prescription changed accordingly.

You can just turn to paragraph 78 which is on page 20. Of your report. I'll just give you a moment to turn that up.

Yeah, I'm there.

And can you just explain your opinion there in regards to ability to supply

at the in the bet for World timeframe, there was no requirement for supplying for drugs under just off formulary interchangeability the submission process except for Newfoundland and Labrador.

And can you just turn to the assumptions I'll ask you about the assumptions you were given? And can you just turn to paragraph 81 which is on page 21.

I am there and can you just

explain to the court the assumptions you were instructed to make for your opinion?

I was asked to assume that pharma science would have applied for OSI designation in Ontario, Nova Scotia Prince Edward Island and Newfoundland and Labrador for PMS. They'll put them on the day it received its noc.

What paragraph 84 in respect of apex is RFI applications

for a protects I was asked to assume that it would make it so submissions as it had done in the real world. And

then, in paragraph 80, for the last few sentences, can you just explain to the court what you're noting there?

I noted that there were delays in the RFI designations for April put them in Nova Scotia and Prince Edward Island. And I don't know why there was a wait for the Oh foi designation was longer in these provinces it could could have been the result of a delay in the actual submission of SSI application before OSI or there could have been problems with the application and not deemed complete by the provinces involved

in the real world, which provinces listed a generic zolpidem product as interchangeable with the brand.

The three provinces that did just generic interchangeable with the brand were Ontario, Nova Scotia and Prince Edward Island.

Okay and did you arrive in an opinion in respect of the buchtel world interchangeability dates? Yes, I did. In my case of a vertex with the same

just turned off

for a report start there at page 22. And there you just indicate the summary of your opinion for April zolpidem

for equals up or down. My opinion was that what happened in the real world would happen in the but for world, namely that Ontario would give the designation on February 26 2016. And Nova Scotia would do so July 6 2015, and Prince Edward Island would designate OSI on October 15 2015.

And with pharma science, in your opinion with provinces would have listed pharma science as well as interchangeable

in my opinion, the same three provinces would designate PMS so podem interchangeable. Again, Ontario, Nova Scotia and Prince Edward Island with the dates being Ontario, February 26 2015, Nova Scotia February 8 2015 in Prince Edward Island on April 15 2015.

Thank you, can you turn to paragraph 116 which is on page 26. And just explain, let me know when you're there and there,

can you just explain to the chairman

for interchangeability date for Ontario?

Ontario has a very transparent submission and review and decision process it has monthly submission dates for when the submission must be received by so in the bud four timeframe. The two dates were December third 2014 and January 7 2015. So the December 3 was not applicable because the NOC had not been issued Yes, yet. So with January 7 2015, in my opinion, the submission is put in on January 2 could have been received by January 7 2015. Ontario lists a report each month indicating which OSI products have had complete submission. complete submission so the applicable report in that time frame was on January 23 2015. I looked at the products on that list and noted that they were designated RFI on February 26 2015. So therefore I picked February 26 2015.

And then in the next paragraph, which is paragraph 127. Can you explain how you determine the budget for interchangeability date for Nova Scotia?

Nova Scotia accepts submissions in the order of receipt. So one has to look at when they did an update on new interchangeable drugs after the date and look at the products on those subsequent updates to determine an appropriate estimated listing date. So in this case, you interchangeable drug products are listed on January 12 2015 February 8, and March 9. In looking at the dates January 12 would probably have been a bit too soon to the January 2 noc date I looked at February 8, and there were other generic products with a similar NOC date. So therefore, I went with that February 8 2015. listing date.

And then lastly, in paragraph one. Province of Prince Edward Island Can you just court

changeability dates for that province,

Prince Edward Island in that time frame published a provincial interchangeable drug list quarterly in April, while January April July and December the January, the submission was required 30 days before the publication of the updated changeable drug list. So the January date would be inappropriate. The April date would allow submissions up to March 25 March 15. To be considered. So there's plenty of time from the NOC of January 2 to march 15 for the submission to be submitted. Therefore, I chose April 15 2015 as the OSI designation date for Edward Island.

Thanks, thank you so much, Mr. Makovski. Those are all my questions.

Thank you very much. This period how long do you think you're going to be in cross examination?

If we still have 10 minutes I will be up and done and we can all be done for the day.

Well, let's let's do the 10 minutes then that would be wonderful. Thank you

although for the corporate, I want to speak even

faster than I tend to Good Good afternoon, Miss Makowski. You have your report in front of you. I believe you were just just reading from it. Could you turn to your schedule RB two.

The final recommendations for zolpidem.

No, I believe twist which are

your your certificate concerning Code of Conduct expert witnesses is that it's not your oh

I'm not sure it's contained in F C one C one is a 31 page document which I don't believe is any of the schedules. In fact,

my notes have that as FC three.

Well, I found to the code of conduct. Is that what you're referring to? Yes, your expert witness code of conduct that I signed on January 13.

Yes, and it is fc three. Correct for the for the record. And yes, you you beat me to it. So you signed on January 13 2020. Correct. And and so you have been involved in this case since at least January 13 20. And you have worked with pharma science in previous BM NOC or sorry, Section Eight proceedings,

correct.

And in your report for this proceeding, as you just took us through you provide your you provide opinion evidence on when in the but for World PMS OpenAM would have been voted off formulary interchangeable in certain provinces.

Correct.

And you understand that your opinion on these issues is relevant for creating the but for World correct.

And specifically, you understood the information set out in in your report would be relied on by pharma sciences economist in in creating the but for world

I knew that they use the information and apply it to their economist accordingly

and know that the economist in this case was Dr. Aden Hollis. And when did you when were you made aware of that?

I am not sure of the exact date that I knew he was involved in this case.

Were you aware that he was involved prior to signing your report? No. So prior to 2021 You did not know Dr. Hollis was involved. Your report date night certificate now I'm talking about

I can't remember exactly when I knew he was involved. I'd have to go back emails to see if I could pinpoint the offhand I can't remember when I became aware of that he was involved in this case.

And were you asked to provide a draft or draft of your report prior to July 5 2021? Yes. And did you understand that these drafts would be reviewed by an economist?

No, I did not know that they would be reviewed by him. I knew that some components of my reports and the graphs would be provided to Dr. Hollis.

And that's how it worked in in prior section eight cases you've worked on as well you you provide the the formulary dates and they're provided to the Economist.

That is my understanding.

And

are you aware that your report was not referenced in Dr. Hollis his report in this proceeding is original one day to July 7 2020.

I did not see Dr. Hostess report. So I don't know what he used in his report.

Any reports by Dr. Hollis in this proceeding? There's more than one is why I'm asking have you seen any reports by Dr. Hollis in this proceeding? No.

And were you asked to make any changes to your July 5 2021 report after it was signed?

Note the report is on July 5.

rating but it was just to make sure we're talking about the same thing. Were you asked to make any revisions to

know the report the end on July 5 25th 2021. Is the report I was using today. Otherwise the have been changed

or you may not have made the changes you may have been asked to make changes decided not to and the the report date would stay the same. That's why I was I want to make sure we're clear you weren't asked to make any changes to you after the July 5 2021 date.

No it was found off on that date and it was the report by us today.

Justice as in more than kept on my time I'm getting emphatic hand waving. Can I have two minutes? I will have less than five questions in less than five minutes.

You got a deal. Thank you got that

and maybe just look out for you. Can I ask for one to be marked as an exhibit? I'm now told it's FC to 34 which are the attachments to miss bucho skis report. My friends have those I apologize can those be made part of the same exhibit?

I was going to raise the same issue. I'm not sure we've actually met all of Mr. Sorry, Mentos schedules and so on as well. Okay. It's been guest counsel about this over the lunch period and make sure we are everything that needs to be marked as exhibit and we will do that okay. So we'll take you have forgotten how many minutes I gave you. Two minutes was it?

Two minutes we'll do it but if we can do two minutes we'll do that's fine. Thank you

Hello. Hello. Sorry according stop.

Can you just stay online for a few minutes while Miss Barrett has a discussion and then we'll be back with you?

Yes, I'll stay here.

Stay there. Please.

recording in progress.

Just a couple more questions, Miss Bukowski. You you were talking earlier about the Ontario OSI paragraphs 113 to 116 of your report. And at paragraph 116 you provide the opinion that both Apotex and pharma science would have met the January 7 25th deadline, correct?

Yes, in my opinion.

And, and we can see actually if we go to your exhibit 16 That Apotex did in fact, meet that January 7 2015 deadline because they're

Yes, they were included on the complete streamline multi source submission for all formulary interchangeability report from the Ontario Drug Programs.

So Apotex in the real world got its NOC December 31 2014 and had its Ontario submission in by January 7 2015. At the latest correct

it would, it would have met the it appears it would have met the submission deadline of January 7.

Right which means it had to be in honor before that. That date.

Correct.

So they completed submitted within a week of their NOC right.

It appears that

those are all my question justice. Then and I have been four but it certainly wasn't more than five.

You have any nomination Mr. Drogon. Oh, nothing

there.

Thank you very much Miss kowski Yeah, you can log off

thank you very much.

And I believe that that is the only witness of the last witness on the scheduled day unless I did list I haven't seen

that's all that we have on our list for today. No surprise witnesses.

And tomorrow we're starting with I can't read my song from 9:30am.

Yes, and one question I have looks like maybe Mr. stainsby has something as well. But just to let you know, we have as part of our case next week, readings going in of the defendants. Not sure those have been resolved. We'll continue to discuss but I'm just letting you know we may need I would think 20 minutes 30 minutes on Monday or Tuesday if we need a motion on that. But I will continue to discuss and let you know. And but my understanding is what we marked as an exhibit earlier in the week. Our readings pardon me. Yes, our readings for our case. I don't think there's going to need to be an issue unless my friends tell you otherwise.

Okay. Let's do stainsby

I just Just as in before we break I just had the FC members of the sheduled for Mr. Soriano and like, just be there or the trial toolkit my friends can can look at them and if they have a problem with that later they can tell you but I just thought if we cleaned it up now then it's done. Would be great. So exhibits 11717

We FC 45 and 46. That's the two packages and schedules. Exhibit 118 We need to add FC 52 and exhibit 119 We need to add FC 59. And as I said initially that they can let us know tomorrow or whatever but I don't think they will

appreciate that and then the last witness is exhibits are FC one through 34 should be exhibit 122. That's correct. Registry two we'll take note of that and make the appropriate Thank you. And then we'll adjourn until 930 tomorrow morning.

Thank you just to say thank you all

recorded as of the journals until tomorrow Friday, November 18 at 930. Recording