Court dismisses appeal against convictions for supplying prescription-only drugs without a doctor's presence or authorization.

THE CIRCUIT COURT AN CHÚIRT CHUARDA

Record No: 2023/728 Neutral Citation: [2024] IECC 1

DUBLIN CIRCUIT CRIMINAL COURT COUNTY OF THE CITY OF DUBLIN

DISTRICT COURT APPEAL

Between

HEALTH PRODUCTS REGULATORY AUTHORITY

Prosecutor

AND

ANNE ROSSI

Appellant

Judgment of Her Honour Judge Jennifer O’Brien this 29th day of February 2024

Background: This matter has a somewhat protracted history in that the date of the earliest alleged offence is 20 November 2014. On foot of a search warrant granted by the District Court, the Health Products Regulatory Authority (previously known as the Irish Medicines Board) (the “Authority”) carried out a search of the Appellant’s home and business premises on 19 February 2015. A District Court summons was issued on 18 November 2016 and the Appellant was charged with a number of offences contrary to Regulation 5 (1) and Regulation

6 (1)(a) of the Medicinal Products (Prescription and Control of Supply) Regulations 2003 (SI number 540 of 2003), as amended by the Medicinal Products (Prescription and Control of

Supply) Regulations 2008 (SI number 512 of 2008), made under Section 32 of the Medicines Board Act 1995 as amended by the Irish Medicines Board (Miscellaneous Provisions) Act 2006 as adapted by the Health (Alteration of Name of Department and Title of Minister) Order 1997, the penalty for which is prescribed under Section 32 (4) of the Irish Medicines Board Acts 1995 and 2006. There are ten District Court convictions against the Appellant which are under appeal to this Court. The hearing before this Court took place on 30 & 31st January 2024.

The case in the District Court was heard over a number of days in June, October and November 2017. A case was stated to the High Court and judgment was given by Mr. Justice MacGrath on 4 November 2019, see [2019] IEHC 723. The High Court replied to each of the questions posed by the District Judge in the affirmative.

Those questions were as follows:

(i) “In the absence of a report as contemplated by Section 32D (1) can the statutory offences in this case be proven by the Ipsen report and other evidence?

(ii) Are the admissions made by the defendant during a voluntary cautioned interview admissible in evidence in circumstances where I am satisfied that the admissions were voluntary, but no statutory provision was invoked to interview the Defendant?”

As such it was for the Trial Judge in the District Court and for this Court on appeal to determine the weight to be given, if any, to the Ipsen report and the contents of the voluntary interview given by the Appellant, under caution, together with the other evidence adduced in the course of this trial. As such this Court must engage in a de novo hearing of the case.

Prosecution case: The prosecutor is the Authority, and the Act makes provision for the appointment of authorized officers upon whom certain powers are conferred, including powers of entry, search and to acquire information and assistance.

The offences are alleged to have occurred on various dates between 20 November 2014 and 19 February 2015. It is alleged that the Appellant supplied a prescription only product and placed a medicinal product on the market without a necessary prescription. It is further alleged that the Appellant placed such a product on the market without the necessary market authorization. The product is Dysport which is manufactured in Wales by Ipsen. It contains Botulinum Toxin

Type A, commonly known as Botox, a prescription only drug. It is used to treat muscular conditions, however in a purified form it is used for cosmetic purposes and to reduce the appearance of wrinkles.

The Appellant is a State registered nurse who conducts business as a beautician at her premises known as the Anne Rossi clinic (the “Clinic”), Clontarf, Dublin. The Authority alleges that the Appellant provided Botox treatment as part of her service without having the necessary prescriptions from doctors. Two witnesses have given evidence to this Court regarding treatments which they received. Medical evidence has also been given and it is claimed that the Appellant’s registration does not authorize her to administer Botox.

The prosecution originated from a statement taken from a client of the Appellant who claims that she received Botox treatment at the Clinic. On 19 February 2015, authorized officers employed by the Authority seized a quantity of Dysport during a search of the Clinic. It is alleged that an offence was committed on the date of the search and on the dates when customers attended and availed of Botox treatment. The authorized officers took a cautioned statement from the Appellant when they were on the business premises. The contents of this statement were read into Court in the course of this hearing.

The Court heard evidence from Dr Mukesh Lalloo regarding his concerns about a patient whom he treated after she attended Ms. Rossi’s clinic in Clontarf. He made a report to the Authority who subsequently applied for a search warrant, which was executed on the 19th of February 2015. Dr Mukesh Lalloo gave evidence that Botox can be dangerous and can cause paralysis. He gave evidence that if the product is injected incorrectly, it can cause a complete abnormal paralysis within the face. He also said that there have been reports of fatalities. He gave evidence that he administers Botox every day, with the consent of the patient, having taken a full medical history. He said there were circumstances in which you would not proceed to administer the product, depending on the particular patient’s requirements. He gave evidence that he was ethically bound to contact the Authority once he became aware of a patient receiving the product Botox, without appropriate authorisation. He explained that Dysport is a prescription only medication which is licensed for medical use and that the particular product is not licensed for cosmetic use. He gave evidence that a physician may use it for cosmetic purposes but only on a prescription basis. Under cross examination, Dr Mukesh Lalloo confirmed that Dysport could be used for cosmetic purposes with the consent of the patient, provided it was administered by a medical doctor, on a prescription only basis. He emphasized that a doctor must prescribe and administer the product. He explained that a nurse can administer the product in the presence of a prescribing doctor, such that the medical practitioner supervised the injections and marked the points for same. He reiterated that whether the use of Dysport is on label or off label, it requires execution of a prescription by a medical practitioner.

The Ipsen report: Both the Ipsen report and the interview given by the Appellant were read into Court. The Ipsen report deals with the sample taken from the fridge at the Clinic which was sent by the Authority for testing. A sample was tested by Ipsen, and the results can be summarized as follows:

• Photographs taken of the samples showed that the samples were typical for vials of Dysport and the associated packaging.

• The results of the Enzyme-Linked ImmunoSorbent Assay (ELISA)

identification test on the first sample of the batch confirmed the presence of Botulinum Toxin Type A in the vial.

• The results of the assay identification test on the second sample of the batch confirmed the presence of Botulinum Toxin Type A in the vial.

• The absorbance readings for sample 1 were consistent in magnitude with the values obtained for the diluted Reference Sample vial. This indicates that the quantity of toxin within the sample was as expected for Dysport 500u/vile.

• The absorbance readings for sample 2 were lower in magnitude than the values obtained for the diluted Reference Sample vial. This indicates that the quantity of toxin within the sample was reduced, which is expected for a partially used vial.

• The results of the HPLC Lactose assay on the first sample of batch confirmed the presence of lactose in the vial.

• The results of the HPLC lactose assay on the second sample of batch confirmed the presence of lactose in the vial.

Statement given under caution: Evidence was given to the effect that at approximately 8.16am on 19 February 2015, the Appellant gave a statement under caution, in a question-andanswer format. The statement opens as follows “You are not obliged to say anything unless you wish to do so, but anything you say will be taken down in writing and may be given in evidence”. The caution was signed by Ms. Rossi and witnessed by Niall McCarthy and Alan

Smullen, both authorized officers of the Authority. The Appellant was asked a number of questions and she gave the following information according to the contents of the statement handed (and read) into Court.

• That she is the sole director/ sole trader and a registered nurse with the registration number of 41265.

• She confirmed she no longer practices as a psychiatric nurse.

• She confirmed she carries out a number of procedures at the Clinic which include colonic irrigation, laser treatment, fillers and vein treatment.

• She confirmed that she has been administering Botox to patients and in particular Dysport which she sourced from the Health Exchange in the UK.

• She used her company credit cards to pay for the product.

• She'd been administering the product for approximately a year and that she was in between doctors at that time and that she had been unable to source a doctor.

• She stated that she was administering Botox to customers who came to her Clinic. She would mark them up, showed them the areas where they needed Botox, and she would then inject them.

• She was then asked whether she was aware that she was not entitled to inject Botox.

She responded that she was on a sticky wicket for the last year or so but that when she was last up with the IMB seven years ago, nurses were assisting doctors in this area.

• She confirmed that no medical practitioner was present when she was administering Botox over the last 12 months.

• She confirmed that she was aware that Botulinum Toxin Type A was subject to prescription controls.

• She confirmed she did not have prescriptions for the Botulinum Toxin Type A supplied to customers.

• She confirmed that over the past 12 months she had supplied and administered Botox to customers about once or twice a week.

• She confirmed that she did not perform facial mapping during consultations with clients for Botox.

• She said that she kept notes on the computer of where the patients received Botox.

• When asked did she have a full list of customers who had received Botox she replied that she did. A list of her customers was furnished which includes details of the treatment received, including Botox treatment.

• She confirmed that her customers paid for Botox either by cash or with a credit card and that she also gave receipts.

• She said that about a year ago Dr. Catherine Mulrooney was working at her clinic and prescribing Botox.

• She confirmed that she had been sourcing the Botox in Dr. Mulrooney’s absence from the Health Exchange.

• She said that she provided the Health Exchange with a cover letter and that she had a blank prescription held on the computer signed by Dr. Mulrooney and that she uses this on occasion when ordering Botox.

• She said she does not put the customer’s names on the prescription. She said that she just sends a cover letter ordering one or two vials about once per fortnight.

• When put to her she confirmed that Dr. Mulrooney was unaware that her prescriptions were being used to order prescription medicines.

• She explained that she faxes in an order to the Health Exchange and that they have her card on file and debit her account. She said she has very little communication with the Health Exchange. She said she also uses a wholesaler in Ireland.

• She explained that the invoice dated 10 February 2015 account for reference ROS02E was an invoice from Health Exchange for Dysport that she had purchased for use at the Clinic.

• She confirmed that the Dysport found in the fridge at the Clinic was the Dysport that the invoice shown to her related to.

• When asked why the Dysport was being stored in a domestic fridge alongside foodstuff she said that she was late going home, and she just threw the product into the fridge.

• When asked whether she had sole access to the fridge, the Appellant responded that the other girls who work at the Clinic use the fridge to keep food. She said that they would not be familiar with the rules and regulations regarding storage of the product. She said that she was familiar with these rules.

• She said that her staff would not be aware that she was not supposed to administer Botox to customers.

• She confirmed that she charged €250 to €300 for each session.

• She confirmed that she pays €600 per box of two vials, including carriage.

• She confirmed that maybe 6 customers could be seen per 2 vials of Botox.

• She said that one vial could be used for different customers.

• The Appellant confirmed the list of client’s names printed from her computer.

• She said it contained a list of customers including client names and procedures carried out by the Appellant.

• The Appellant confirmed that this document also lists the customers to whom she had administered Botox.

• The Appellant was shown six emails dated 13 November 2014, 24 November 2014, 2 December 2014, 11 December 2014, 16 December 2014 and 18 December 2014. Each of these emails had a prescription (printed copy from Appellant’s computer) attached to it and was asked to explain same. The Appellant responded that they were the order forms sent to Health Exchange and that each lists one Dysport 500-unit vial. When asked whether she completed the prescriptions in the name Anne Rossi, the Appellant responded that she did.

• When asked why all the prescriptions were dated 3 October 2014 the Appellant responded that she was fudging the dates.

• When asked to explain what she meant by that the Appellant responded we just changed the dates on the cover letters to order Dysport stock. When asked whether this was a genuine prescription the Appellant responded that it was not.

• When asked whether the prescription was a forgery the Appellant responded that it was completed by her.

• When asked whether there was anything she would like to add at this time the Appellant responded that she was in the process of sourcing Botox legitimately, but she couldn't find a doctor.

• She said that she was trained in administering Botox and that she had a certificate to prove that. She said she was doing her best to contact doctors knowing they should have been on the premises administering for her.

• The statement concluded with the words “I have read over the above statement, and I have been informed I can make additions or corrections as thought necessary. The above statement is correct”. The Appellant then signed the statement which is witnessed by the two officers.

The information sworn by Niall McCarthy for the purpose of applying for a search warrant was read into Court and the content of the search warrant dated 17 February 2015 was read into Court.

• The Court was then given copies of the patient invoices with the Health Exchange which contained a number of orders for Dysport 500 (Dual Pack). The Court was also given copies of the patient list as referred to in the course of the Appellant’s statement.

• The list includes details of patient names and those who were to receive Botox and Botox top ups.

• Each of these documents was signed and dated by the Appellant.

• The Court was also given copy fax cover sheets and cover letters together with copies of prescriptions for Dysport which had been referred to by the Appellant in the course of her voluntary statement.

• The Court was also given photographs of the kitchen at the Clinic which include photographs of the contents of the fridge and, which shows the Dysport product on the top shelf of the fridge, adjacent to food products. These photographs illustrate that a carton of Dysport together with two vials were taken from the fridge and there is also a photograph of the sealed product in preparation for transfer of same to the testing authority.

Evidence of ladies receiving Botox treatment: The Court heard evidence from two ladies who had attended at the Appellant’s Clinic.

The first witness gave evidence that she attended Anne Rossi’s clinic in late 2014 early 2015 for the purpose of receiving Botox treatment. She gave evidence that she could not recall whether she gave a medical history and that she paid €250 for the treatment. She gave evidence that on the occasion when she returned for further Botox top ups, she did not recall any discussion about her medical history. She gave evidence that other than the Appellant, no one else was present during the course of her treatment. She gave evidence that she was not aware of any prescription being written for this product. Under cross examination, the first lady confirmed that she had no complaint against Ms. Rossi and that she had no issues with the treatment. She confirmed that she had been summonsed to Court for the purpose of giving evidence.

The second lady gave evidence that she had received Botox treatment at Ms. Rossi’s clinic in early 2015 and she recollected filling out a form when she attended on the first occasion providing some medical details. She gave evidence that the Appellant did not ask her any questions other than where she would like the treatment and that she marked out points on her forehead for the purpose of injecting into the marked area. She gave evidence that she then left the treatment room and paid. She confirmed that she returned a few weeks later for a top up. She said she had a slight reaction to the product on the second occasion which caused an abscess near her eye and spots on her forehead. Under cross examination, she confirmed that she had no complaint about the treatment, and she was happy to go back for any treatment.

Evidence given on behalf of the Authority: Niall McCarthy, an authorized officer on behalf of the Authority gave evidence that he has worked for the Authority since 2001. He gave evidence that in this instance he had cause to take a statement from an individual who had attended at Dr. Mukesh Lalloo. On foot of this statement, he applied for a search warrant in the District Court. He gave evidence regarding the manner in which the search was carried out on 19 February 2015. They called to the Appellant’s home at 7:30am. He said that a number of authorized individuals attended with him for the purpose of carrying out the search. It was explained to the Appellant that they were looking for medical products and they went to the kitchen area for this purpose. He confirmed that no medical Botox was found at the premises and the Appellant informed them that there was some at the business premises. Some invoices were found for Dysport 500 at the home address and further invoices were found at the Clinic. The Appellant attended at the clinic for the purpose of the search of the premises by the authorized officers. He gave evidence that the Appellant brought the authorized officers to the fridge at the Clinic premises and pointed out the Dysport to him which was being stored inside the fridge door. He gave evidence that a number of trading invoices with Health Exchange were found at the Clinic together with the client list and communications about the prescriptions for Botox. He gave evidence of the statement taken from the Appellant under caution.

Under cross examination, he confirmed that the warrant was for the home address as they expected that the product would be kept at the dwelling rather than at the Clinic. It was put to him that the off-label use of Dysport was a matter that was outside the remit of the Authority and in those circumstances, it was the responsibility of the provider. He gave evidence that this product was produced for the UK market only and that any guidance given for the use of the product would be by a medical practitioner. He said that the marketing authorisation has to be in place and that each product has to have a licence number. He explained that it is a national level authorisation and that Ipsen have the marketing authority and it is registered through the Irish board. He said that one vial should be used for each patient, and they were not authorized to share them. He said that on finding the vials in the fridge at the premises, the Authority took the decision to contact those on the client list so as to ascertain whether the product had been used.

Mr. Alan Smullen, an enforcement officer with the Authority also gave evidence regarding the taking of a statement from Ms. Rossi at the start of the investigation. He attended the search carried out on 19 February 2015 when they went to the Appellant’s home for the purpose of executing the search warrant. He gave evidence that when they went to the Appellant’s Clinic, she showed him where the Dysport was kept in the fridge at approximately 8:15 AM on that occasion. He gave evidence regarding the interview of the Appellant under caution and the statement that was taken which was recorded in question-and-answer format. He recounted that the Appellant was asked if she would like to make any changes to the document and that she signed it and left the premises. He gave evidence that Botox or Botulinum Toxin Type A is a schedule one medicinal product under the Regulation and all active substances are subject to a prescription, further that this product was not subject to marketing authorization in Ireland. He said there are licensed products here but that this particular product was not authorized for supply in this jurisdiction. He gave evidence that there was no community marketing authorisation, no traditional use registration nor was the product referenced for veterinary use in Ireland. He gave evidence that in so far as this medication is available for off label use a medical practitioner can request it for a patient’s needs and it can be imported by a licensed wholesaler and prescribed by a medical doctor or a dentist. When asked under cross examination why this issue was not dealt with in the statements Mr. Smullen gave evidence that the product was not authorized for use in this jurisdiction and that the products were issued with different batch numbers depending on which market they were authorized and for sale in. He said that the vials were licensed PL which is only for the UK market. On redirect, the witness gave evidence that the photos attached to the Ipsen report contain a box which has a PL number indicating that it is a product for the UK market. Products for the Irish market would have a PA number. He explained that the logic is where a product which is supplied to the UK market only becomes subject to a recall that recall can take place in the same market and as such the products are not dual authorized. He also referred to the invoices taken from the Clinic premises which indicated the use of a UK supplier for the product in this case.

Officer Ciaran Wright also gave evidence for the Authority, in that he is the Exhibits Officer for the items taken at the Clinic in Vernon Ave. He took photographs of the fridge and the products and used a digital camera for this purpose. He downloaded these photos to an electronic case file, the bundle of photographs have been proved and filed with the Court. He gave evidence that exhibit 6 shows the staff room where vials were kept. He said there is a domestic fridge which contains food and that vials of the product were found on the top shelf of the fridge together with Dysport packaging. These vials were sent to Ipsen for analysis and reference was made to the Ipsen report in this regard. He also put together the prescriptions, invoices and the client list and carefully sealed all evidence taken from the premises. He explained the care that was taken in transfer of the vials to the company in the UK. He explained the stopper was put into the vial to protect the product for further applications.

Officer Mr. McCarthy was recalled into evidence and asked whether all of the invoices related to boxes that were in dual packs. He responded that they were.

Mr. McInerney of Ipsen was heard by video link and he answered questions raised by the Appellant, as follows:

Q. If I could just direct your attention to the first page of the Ipsen report that you sent back for the Botox samples, it says at 12:25pm on the 20th of October 2015 a vial and a carton of Dysport 1 vial pack was received at Ipsen.

A. Yeah, that’s correct.

Q. Were you involved in the testing of this?

A.I personally was not - I have not been with the company for that long.

Q. Have you any reason to believe that what is said in that first line isn't correct?

A. No I've got no reason to believe that's incorrect.

Q. Can I just clarify that Dysport comes in a 1 vial and a 2-vial pack?

A. Correct

Q. This clearly says that you received a one vial pack of Dysport, is that correct?

A. Yes, and a separate vial.

Q. So as far as you're concerned it was a 1 vial pack and a separate vial?

A. Correct

Q. Can I direct your view to the photographs in the report, specifically to the last photograph, numbered DSC 5196. Could you tell me what that is?

A. That is the stopper which is put into the vial to protect it prior to being crimped and it allows for the user to pierce, reconstitute and withdraw the medicinal product.

Q. Would this have been contained in the box or on the vial?

A. On the vial, my understanding is that it’s the same stopper that has been removed from photograph 5195 to show the state of it and whether it's been used or not.

The Court notes that the photographs attached to the Ipsen report clearly illustrate packaging for a dual vial rather than a single vial of the product.

Application for a direction: Counsel for the Appellant made an application for a direction in the matter under three broad categories. It was acknowledged that the charges relating to offences alleged on 20 November 2014 are dismissed and the appeal can be allowed on each of those charge sheets. With regard to the other charges regarding supply of medicinal product without prescription and placement on the market otherwise than in accordance with the marketing authority, counsel for the Appellant submitted that the doctor had not been called into evidence for the purpose of proving the content of the written prescriptions. It was submitted that the State had not come up to proof on the prescriptions and that hearsay documents had been handed into Court. Counsel for the Appellant submitted that prescriptions can be written for the product to be used off label and as such in those circumstances the Authority has no role and reference was made to page 4 of the Authority’s website document. That document provides in response to question 15 “what is ‘offlabel’ use?”

“’Off label’ use is the use of an authorized medicine outside the terms of its product authorisation e.g., use for an indication not specified in the authorized product information; Use at a dose not specified in the authorized product information; Use in a specific patient population or a specific agegroup not specified in the authorized product information.

Question 16: Can a registered medical doctor or dentist use a medicine off label?

Yes, however, such use cannot be considered to be within the terms of the product authorisation as issued by the IMB as such it is outside the remit of the IMB. It should be noted that such use falls within the professional responsibility of the prescriber.

Question 17: Should a registered medical doctor/ dentist inform the IMB when an authorized medicinal product is used off label?

No, the IMB does not have any responsibility for overseeing the off-label use of medicinal products by healthcare professionals.”

Counsel submits that the prescriber is Dr. Mulrooney, and that the Authority has no remit once the prescription is filled for off-label use.

The next point raised by counsel for the Appellant is that the product is an authorized product which could be sold on the market and that nothing has been handed into Court to prove that there is no marketing authorization for the product and as such the charges should fall. With regard to proof of the prescription and proof of the marketing authorization, it was submitted that a jury could not convict the Appellant.

In response, counsel for the prosecution referred the Court to the test to be applied that is from the Galbraith case. It was submitted that the prosecution case must be taken at its highest as to whether a jury properly charged would be entitled to convict. As such, it does not require either the jury or the judge to weigh the evidence at this juncture. There are two sets of charges, that is the charge to supply prescription only medication and the placement on the market without authority. It was submitted that there is evidence of each. The evidence was summarized as follows:

• Ms. Rossi gave an interview and made certain admissions under caution which included details of client lists, prescriptions and orders for the product.

• Ms. Rossi explained that she was ‘in between doctors’ and she accepted that she was on ‘a sticky wicket’ and she used blank prescriptions for the purpose of ordering the medication.

• Ms. Rossi made admissions together with the evidence of the ladies who had been treated and had had Botox administered to them by the Appellant without prescription.

• The ladies gave evidence that the Appellant had been on her own when she administered the product.

• There is reference to the names of the ladies (who gave evidence) in the practice calendar.

• There is further evidence of the order forms sent to Health Exchange for the purpose of purchasing Botox from the UK.

• The evidence of the vials of Dysport found in the fridge which had its contents analyzed and confirmed.

• It is further submitted that the Court is entitled to rely on the unchallenged evidence of Mr. Smullen that this product had no authorization in this jurisdiction. It was noted that Dysport does have authorization in this jurisdiction, but that the product purchased through a UK provider does not have such authorization.

• It was submitted that the argument raised on behalf of the Appellant that this can be done off label is not valid as it can only be done off label by a prescribing doctor. It's an activity which requires a prescription.

• It is submitted that prescription is a gateway through which a doctor must determine firstly whether it is appropriate to prescribe the product.

• As such, it was submitted on behalf of the prosecution a prima facie case had been made out to the Court.

The Court considered what was offered by both counsel and made a determination that a prima facie case had been made out.

Appellant’s witness: The Appellant’s counsel then called Mr. Kieran Rossi into evidence. Mr. Rossi gave evidence of what occurred on the date of the search and that he was greeted by five officers who informed him of the search warrant granted by the District Court. They informed him that they would search the residence for Botox. Mr. Rossi gave evidence that he denied the officers access to the property but that the five officers entered their home. He said the officer kept saying that the Botox would be kept in the fridge. He said that the fridge was then searched. He gave evidence that a large brown envelope was taken from the fridge. He gave evidence that at no stage was he cautioned. He gave evidence that he felt the officers had greeted him with mirth. He gave evidence that the officers told him that this was not a criminal investigation. He said they informed him that they were only trying to take the product out of circulation. He gave evidence that his wife was asked whether there was Botox in the house to which she responded in the negative. She had confirmed that there was a small amount of the product at the Clinic.

Mr. Rossi gave evidence that the officer then made a phone call and that they decided to leave the house and attend at the Clinic. Mr. Rossi gave evidence that both himself and his wife were informed that if they gave the officers what they wanted, that they would be gone, and Ms. Rossi would be able to open her clinic on time for business. He gave evidence that Mr. McCarthy approached the Appellant and knocked on her car window. He said that Mr. McCarthy told Ms. Rossi that this was not a criminal investigation and that she had nothing to worry about. Mr. Rossi gave evidence that he remained at the house while his wife and the authorized officers attended at the Clinic. He gave evidence that he had spent some time working at the Clinic himself and that he would empty the bins including the sharps bin. He said that his wife ran a high-end medical aesthetics clinic. He said she carried out all sorts of treatments at the Clinic. He said that he was aware of the type of Botox product that the Clinic was using and that he was not aware of the broader inventory of products used at the Clinic. He gave evidence that he had not seen the particular vial of product that was depicted in the photographs and the Ipsen report. Under cross examination, he confirmed that he had never seen the Botox at the Clinic previously. He gave evidence that he was not aware that the Appellant was forging prescriptions. He gave further evidence that he did not believe the Appellant had made the admissions contained in the voluntary statement. For instance, he said that the Appellant did not know her nursing registration number nor did she use the phrase “sticky wicket”. He said he did not believe that the Appellant knew what that meant. He said that he did not believe that the words used in the voluntary admission were the words the Appellant would use. For example, the words “drawn on Bank of Ireland” - he said that the Appellant would not use these words.

Mr. Rossi gave evidence that he had not seen the client records. He was asked why none of these matters were raised in the District Court, that is the idea that Ms. Rossi had not made the voluntary statement. He was also asked why these suggestions with regard to the interview were not put to the other witnesses in cross-examination. He was asked why the issue about refusal of entry to the property was never put to the other witnesses.

He was asked why the issue about the envelope taken from the fridge was not put to Mr. Smullen. He was asked why he didn’t attend the Clinic with the Appellant on the morning of the search to which he responded that he feared the officers would return to the house. He said he did not trust them. He reiterated that he had never seen the Botox at the Clinic.

Submissions: Counsel for the prosecution then raised a legal matter with regard to the requirement that any conflict in evidence is to be put to the witnesses. Reference was made to a decision of Baker J in the High Court, DPP v Burke [2014] IEHC 483 and it was submitted that such a conflict in evidence should be put to the witnesses under crossexamination. It was submitted that evidence that had not been put to the other witnesses should not have been given in this manner. It was submitted that the evidence given by Mr. McCarthy and Mr. Smullen on these matters was untested and uncontradicted. It was further submitted that in these circumstances, the Court must hear all of the evidence before deciding on the weight to be given to each part of the evidence. It was submitted that the unchallenged evidence is part of the evidence of the trial. It was further submitted that the Court is entitled to attach more weight to the evidence where it was put to the witnesses. Such evidence can be given much greater weight. It was submitted that the evidence given by the officers of the Authority and the witnesses for the prosecution was completely untested and uncontradicted. It was submitted that the Appellant’s counsel was not entitled to make submissions which relied on the unchallenged evidence given by Mr. Rossi which had not been put to the other witnesses.

Reference was made by counsel for the Authority to the case stated by the District Court Judge in this case to the High Court and the decision of MacGrath J regarding the admissibility of the voluntary statement given under caution and the admissibility of the Ipsen report. It was submitted that the witness (the Appellant) was cautioned and that there was a frankness and openness about what she was doing in that she couldn’t source a doctor at that time. It was submitted that this document should be given particular weight in terms of being a declaration against interest, which is admissible and carries greater weight. It was submitted that the evidence given by the ladies was not tested and they gave evidence that they received Botox on the days in question. They gave evidence of the treatment received and that there were no prescriptions. Reference was made to the Dysport received from the UK using the forged prescriptions. Reference was also made to the Dysport product found in the fridge identified as Botox and the Clinic calendar which contained the dates on which the two female witnesses had received same.

Counsel referred to the Buckley decision [2007] IEHC 150 and to the circumstances arising in that case where the defendant admitted smoking cannabis. He was found with a hash pipe and a knife, and a sample of the substance was sent for analysis, when it was lost. The question was whether the case should proceed without proof of the controlled drug. Counsel referred to page 752 of the High Court judgment (IR) which provides:

“In Re Chatwood [1980]1 WLR 874 the only evidence against the accused men was that they had admitted after caution that they had been injecting themselves with heroin. By this stage the evidence was, for that reason, missing. One of the accused persons went into evidence and said that he had been injecting himself with flour. The Court of Criminal Appeal, per Forbes J, applied the judgment of Lord Widgery CJ in Bird v Adams [1972] Crim LR 174 and stated at page 879:

“…it is apparent that the statements of the appellants, in this case, either orally to the police officer, or when reduced to writing, was sufficient to provide prima facie evidence of the nature of the substance which had been in their possession. One of them, Proctor, as I have indicated, gave evidence, but what I have said about his statement to the police and the fact that he was found guilty by the jury indicates quite clearly that the jury disbelieved his explanation that it was flour and believed his earlier statement to the police that he knew it was heroin.”

So, in that case, Charleton J went on to find “in all the circumstances of this case, that there was sufficient prima facie proof through the admission of the accused, coupled with the pipe and the knife, that the substance in his back trouser pocket was the relevant controlled drug.”

The prosecution submitted that in the instant case the Court has to weigh all of the available evidence prior to reaching a decision in the matter. There was no question that prescriptions were used and as such that must have been done with knowledge. The charges relating to the incident which occurred on 20 November 2014 could be dropped.

Counsel for the Appellant repeated the points made when seeking the direction but at the higher burden of proof. It was submitted that while the Appellant did make admissions the Court could weigh all of the evidence. It was submitted that the prescriptions were not proved, and the doctor did not come to Court to say that she did not sign the prescriptions. It was submitted that prescriptions can now be emailed back and that one does not have to see a doctor to get a prescription. Reference was also made to the fact that one of the ladies couldn't remember whether or not she had been asked about her medical history. As such it was submitted that a medical history may have been taken in relation to one of these witnesses. It was submitted that the Court must be satisfied beyond a reasonable doubt as to whether a prescription had been provided or not.

With regard to the charges as to whether the product was placed on the market with actual authorization, it was submitted that there was no evidence that this was not an authorized product. It was submitted that this case could be distinguished from Buckley as admissions made could be enough evidence in a drugs case where the drug had been taken. Reference was made to page 753 of the decision “Cases proceed on the basis of direct evidence and circumstantial evidence. Here, there was both. The admission by the accused…constituted an admission against interest and was therefore admissible against him. A piece of direct evidence should never be divorced from its factual background. Instead, it should be considered in light of all the evidence in the case.” It was submitted that the prosecutor chose to weaken their case by not providing a certificate of analysis in this case and that other proofs not furnished have further weakened the prosecution case. It was submitted that the Court must have some doubt regarding the prescription and further that the Court must have some doubt that the products were provided without authority.

Decision: The Court must consider, based on the evidence heard at the trial, whether the Appellant supplied a prescription only product and placed a medicinal product on the market without a necessary prescription. Further, the Court must consider whether the Appellant placed products on the market otherwise than in accordance with the marketing authority. Counsel for the Appellant submits that prescriptions signed by Dr Mulrooney have been provided and as such, the prosecution have failed to make out their case, as they have not called the doctor into evidence. The Court notes that even on the face of each prescription provided to the Court there are a number of highly unusual features.

Each prescription is made out to the Appellant and each prescription bears the same date.

The individual patient’s name (and the ultimate recipient of the Dysport product) is not included on the prescription. Counsel submitted that prescriptions can be obtained by email however, it is clear in this case that no individual prescriptions were made out to the ladies attending the Clinic, for treatment. In her voluntary statement given under caution, the Appellant admits forging the prescriptions in the sense that she printed them and attached a cover letter to the company in the UK for the purpose of purchasing the product.

She also admits that she was “in between doctors” for a period of 12 months and she also admits administering the product without the presence of a medical doctor. She acknowledged that Dr Mulrooney was unaware that she was using her prescriptions in this manner. The two ladies who gave evidence confirmed that Botox had been administered to each of them by the Appellant, without the presence of any other individual. The Clinic diary contains names of clients and details of the type of treatment scheduled, which includes Botox for a number of entries. The Ipsen report confirms that the product found in the Appellant’s fridge is consistent with the product Dysport in terms of associated packaging and vial content.

The Appellant’s husband gave evidence that he did not consent to the search of the house. He also said that the Authority’s officers assured both the Appellant and him that there was no need to be concerned, that the investigation would not result in a criminal process. He gave evidence that the Authority’s officers had stated that they were merely seeking to take the product out of circulation. This evidence on the part of Mr. Rossi was never put to any of the prosecution witnesses. The witnesses for the Authority were not challenged in their evidence regarding the conduct of the inspection and the conduct of the interview with the Appellant. The Court refers to the decision of the DPP v Buckley and to Charleton J’s decision in the High Court at page 753: “Cases proceed on the basis of direct evidence and circumstantial evidence. Here, there was both. The admission by the accused…constituted an admission against interest and was therefore admissible against him. A piece of direct evidence should never be divorced from its factual background. Instead, it should be considered in light of all the evidence in the case.” The Court also relies on the decision of Baker J in DPP v Burke [2014] IEHC 483 in which she considered the ratio in Browne v Dunn [1893] 6 R 67 and the consequences of a failure to cross-examine. In that case Baker J considers the status of evidence not put to a witness for the other party and whether and how such evidence is admissible. Baker J also considers how a court is to treat evidence which has not been challenged in cross-examination. Reference is made to McGrath in his text Evidence “that if a party intends to impeach the credibility of a witness, fairness requires that the matter impugned should be put to that witness.” In her

decision Baker J makes a distinction in the context of a criminal trial and goes on to say at paragraph 33 “.it seems to me that there is no rule of law that requires a party to enter upon cross-examination of a witness”. Paragraph 35 provides:

“This brings me to the question of how to characterize unchallenged evidence. Evidence which is not tested by cross-examination is untested or unchallenged evidence and the party not testing evidence raises the risk that the unchallenged evidence will be determinative of an issue, and unchallenged or untested evidence carries a particular weight. This is so as a matter of good sense: evidence which is not tested by the means available under our law may not be ignored or challenged by a collateral or indirect attack.”

Baker J concludes that “the trial judge must consider all of the evidence before her and take her own judgment as to which version of events she believes, and whether there is a reasonable doubt in her mind.”

As such the Court in reaching its determination in this case has given consideration to all of the available evidence however, greater weight is given to the unchallenged evidence of the Authority regarding the conduct of the search and the process of interviewing the Appellant.

Having heard the evidence in this matter, the Court is satisfied beyond all reasonable doubt that the Appellant knowingly supplied a prescription only product that is Dysport and that she placed this product on the market without a necessary prescription. The Appellant also administered the product to her clients without the presence of a medical doctor. There was no medical consultation conducted by a medical doctor or dentist with either of the two witnesses. As such the Court finds the Appellant guilty of an offence (on four counts) contrary to Regulation 5(1).

Further, the Court has considered the evidence surrounding the manner in which the Appellant ordered the product from a UK provider. The Appellant’s voluntary statement given under caution contains a number of admissions with regard to sending facsimiles to the UK provider, payment for the product on the company credit card and receipt of invoices from the company. The Court has been furnished with copies of the facsimiles and of the prescriptions together with copies of the invoices. The Court accepts the evidence adduced on behalf of the Authority regarding the search carried out at the Appellant’s home and at the Clinic, during which vials of the Dysport product were found together with orders, prescriptions and invoices from the UK provider. The Court has heard from a representative of Ipsen and the Ipsen report has been admitted into evidence, which confirms the content of the vials, found at the Appellant’s Clinic. Mr. Rossi said in evidence that he did not recognize the vials photographed in the Ipsen report, however, under cross-examination he acknowledged that he was not familiar with the product in any event. Mr. Smullen, on behalf of the Authority, gave evidence that Dysport products authorized for the UK market have a PL number, as marked on the packaging of the product found at the Appellant’s Clinic. Dysport product with a product authorization for the Irish market has a PA number.

The Court accepts based on the totality of evidence given at the trial and beyond all reasonable doubt that the Appellant knowingly imported Dysport from a UK provider and as such she distributed a product that was not authorized for the Irish market. The Court therefore finds the Appellant guilty of an offence (on four counts) under Regulation 6(1)(a).

The Court therefore dismisses the appeal and affirms the orders of the District Court.

The Court imposed a fine of €1,000 in respect of each count, totaling €8,000 to be paid within

6 months. The Court directed the Appellant to discharge €5,170 (as agreed) towards the costs of the prosecutor to be paid within 8 months.