Case Law Database

Falsified medical products

Keywords

• Medical product
• Distribution of a falsified medical product

Health Products Regulatory Authority v Taj Accura Pharmaceuticals Ltd (DC, 22 June 2018)

Fact Summary

Taj Accura Pharmaceuticals Ltd (‘Taj Accura’) was a registered company in Ireland. It was related to Taj Pharmaceuticals Ltd, a company registered in India, which itself out as a supplier of oncology-indicated medicines. Taj Accura held itself out as being responsible for the sales and marketing of Taj Pharmaceuticals Ltd.

Following the receipt of a request for assistance from the Israeli Ministry of Health on 29 February 2016, the Irish Health Products Regulatory Authority (HPRA) launched an investigation into the dealings of Taj Accura between June 2015 and April 2016.

The HPRA laid a number of charges against Taj Accura, one of its directors, Defendant 2, and a shadow director, Defendant 3. These charges were laid under the Medicinal Products (Control of Wholesale Distribution) Regulations 2007, the Medicinal Products (Control of Manufacture) Regulations 2007 and the Medicinal Products (Control of Placing on the Market) Regulations 2007. The charges related to selling, selling by wholesale, brokering by wholesale, importing, exporting, placing into circulation and introducing into Ireland falsified medicinal products for the treatment of cancers. The charges related to medical products sold to pharmaceutical companies in Iran, Kuwait, Israel, and the United Kingdom where the defendants had made misrepresentations about the source of the medical products.

The three accused each pleaded guilty to a number of the charges laid against them. On 22 June 2018, convictions were recorded against each of the three accused for these charges and the remaining charges were struck out by consent. The three accused were ordered to pay fine of EUR 1000 each.

Sentence Date:
2018-06-22

Cross-Cutting Issues

Liability

... for

• completed offence

... based on

• criminal intention

... as involves

• principal offender(s)
• legal persons (corporations)

Offending

Details

• involved an organized criminal group (Article 2(a) CTOC)
• occurred across one (or more) international borders (transnationally)

Involved Countries

Ireland

United Kingdom of Great Britain and Northern Ireland

Israel

Iran (Islamic Republic of)

Kuwait

India

Turkey

Investigation Procedure

Involved Agencies

• Health Products Regulatory Authority (Ireland)
• Ministry of Health (Israel)

Comments

The investigation into Taj Accura began when, on 29 February 2016, the Irish HPRA received a request for assistance from the Ministry of Health, Israel. This request concerned an alleged supply of a falsified medicinal product, BiCNU, by Taj Accura. This falsified medicinal product had been allegedly supplied, along with associated falsified documentation, to Raz Pharmaceuticals Ltd, in Israel. The HPRA’s investigation into Taj Accura following the receipt of this request from the Israeli Ministry of Health uncovered the commission of a number of other offences related to falsified medicinal products by Taj Accura and Defendants 2 and 3. HPRA’s investigation into Taj Accura was focused on the company’s dealings between June 2015 and April 2016.

 

Procedural Information

Legal System:
Common Law
Latest Court Ruling:
Court of 1st Instance
Type of Proceeding:
Criminal
 
 
Proceeding #1:
  • Stage:
    first trial
  • Official Case Reference:
    Health Products Regulatory Authority v Taj Accura Pharmaceuticals Ltd (DC, 22 June 2018)
  • Court

    Location

  • City/Town:
    Dublin
  • Province:
    Leinster
  • • Criminal

    Description

    The Director of Public Prosecutions elected for the matter to be heard summarily and the three accused pleaded guilty to six of the 11 charges. At a sitting of the District Court of Ireland in Dublin on 22 June 2018, the three accused were formally convicted of the six charges and the remaining charges were stuck out by the consent of the parties (Editorial note: from the order of 22 June 2018, the identity of the six charges for which the accused were convicted is not fully clear).

    The judge sentenced each defendant to a fine of EUR 1000. In giving such a sentence, the court took into account a number of mitigating factors. These included the fact that this was the first offence for each of the three accused, that there was a low probability of reoffending, that there was a loss of professional standing for both Defendants 2 and 3, a commitment had been made to the court that Taj Accura would no longer trade, and that commitments had been made by Defendants 2 and 3 that they would no longer engage in any business regarding health products regulated by the HPRA. Furthermore, the fact that the three accused had entered guilty pleas was a significant mitigating factor, and the court stated that had the accused not pleaded guilty and had subsequently been convicted at trial, a sentence of imprisonment would have been in order.

     

    Defendants / Respondents in the first instance

    Defendant:
    Taj Accura Pharmaceuticals Ltd
    Nationality:
    Irish

    Taj Accura Pharmaceuticals Ltd (‘Taj Accura’) was a registered company in Ireland and the holder of a Wholesaler’s Distribution Authorisation and Broker’s Registration granted by the Irish Health Products Regulatory Authority (HPRA). The Wholesale Distribution Authorisation had been granted to Taj Accura on 3 September 2015 and permitted Taj Accura to wholesale medicinal products within the European Economic Area (EEA), but not outside it. Likewise, the Broker’s Registration also did not permit Taj Accura to broke medicinal products outside the EEA. Furthermore of these documents permitted Taj Accura to import into Ireland or the EU or export medicinal products from Ireland outside the EU.

    Taj Accura had directors from Ireland and India. The directors from India were common with the directors of Taj Pharmaceuticals Ltd, a company registered and operating in India. Among Taj Accura’s directors was Defendant 2. Defendant 2 acted as the main sales and marketing executive of Taj Accura. Defendant 2’s father, Defendant 3, was not a listed director of Taj Accura but held himself out as the chairman and chief executive of the company and was considered by the HPRA to be a shadow directory of the company. There was a further director of Taj Accura who was not prosecuted in relation this case.

    Taj Pharmaceuticals Ltd, the company registered in India, held itself out as a supplier of oncology-indicated medicines. Taj Accura held itself out as being responsible for the sales and marketing of Taj Pharmaceuticals Ltd.

    Defendant:
    Defendant 2
    Gender:
    Female

    Defendant 2 acted as the main sales and marketing executive of Taj Accura. She was a qualified barrister but had ceased to practise law after becoming involved with Taj Accura around 2014. She was the daughter of Defendant 3.

    Defendant:
    Defendant 3
    Gender:
    Male

    Defendant 3 was not a listed director of Taj Accura but held himself out as the chairman and chief executive of the company and was considered by the HPRA to be a shadow directory of the company. Defendant 3 was also a practising dental surgeon and the father of Defendant 3.

    Charges / Claims / Decisions

    Defendant:
    Taj Accura Pharmaceuticals Ltd
    Legislation / Statute / Code:

    Medicinal Products (Control of Wholesale Distribution) Regulations 2007 reg 14B

    Charge details:

    Falsified medicinal products

    The first charge, Charge No 1 of Case No S:2018/2017, concerned the sale by wholesale, between 16 November 2015 and 22 December 2015, of a medicinal product (namely ‘Fluorouracil 50 Injection 250mg’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product.

    This medicinal product had been sold by Taj Accura to an Iranian pharmaceutical company, Tosse Amin Daru Arad, for supply to the Iranian Ministry of Health and Medical Education. The medicinal product had been dispatched from Mumbai, India, to Iran, and payment was made to Taj Accura by a German intermediary on behalf of the Iranian company.

    During the negotiations for the sale and supply of 100,000 ampoules of Fluorouracil 50 Injection 250mg, the defendants had made a number of misrepresentations as to the source of the medicinal product. These included:

    (a) an email on 18 June 2015 sent by Defendant 2 to Tosse Amin Daru Arad including an image of the product falsely showing that it had been manufactured for Taj Accura by Taj Pharma (UK) Ltd, along with the address of an unrelated UK pharmaceutical company; and

    (b) packaging of the 100,000 ampoules of the medicinal product sold and supplied to Tosse Amin Daru Arad which bore the same false details on its packaging.

    The three accused pleaded guilty to this charge and were convicted. They were each ordered to pay a fine of EUR 1000 for this offence. In reaching this sentence, the District Court also took into account the five other charges to which the three accused pleaded guilty.

    Verdict:
    Guilty
    Legislation / Statute / Code:

    Medicinal Products (Control of Wholesale Distribution) Regulations 2007 reg 14B

    Charge details:

    Falsified medicinal products

    The second charge, Charge No 1 of Case No S:2018/2020, concerned the brokerage by wholesale, between 11 August 2015 and 29 January 2016, of a medicinal product (namely ‘BiCNU (Carmustine for Injection USP 100mg)’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product.

    This charge related to the matter referred to the HPRA by the Israeli Ministry of Health concerning the brokerage by wholesale of BiCNU, an oncology-indicated medicine. The rights to manufacture BiCNU were held by Emcure Pharmaceuticals Ltd, which had not authorised either Taj Accura or Taj Pharmaceuticals Ltd to manufacture the product. A Certificate of Analysis produced by Taj Accura listed a licence number issued by the UK Medicines and Healthcare products Regulatory Agency which Taj Accura was not entitled to use. It further provided falsified and inconsistent dates of analysis, sampling and completion of the certificate. An email between Taj Pharmaceuticals Ltd and Taj Accura dated 11 December 2015 also included a batch number for the product which was falsified and falsely represented that the product had been manufactured by Emcure Pharmaceuticals Ltd. Scanned photos of BiCNU cartons attached to the email also showed the same falsified batch number on the carton.

    This charge was ultimately struck out by consent following the three accused pleading guilty to other charges involved in this case.

    Verdict:
    Other
    Legislation / Statute / Code:

    Medicinal Products (Control of Wholesale Distribution) Regulations 2007 reg 14B

    Charge details:

    Falsified medicinal products

    The third charge, Charge No 1 of Case No S:2018/2032, concerned the sale by wholesale, on or about 29 January 2016, of a medicinal product (namely ‘BiCNU (Carmustine for Injection USP 100mg)’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product.

    The factual background to this charge was the same as the factual background set out in the second charge, Charge No 1 of Case No S:2018/2020, above.

    As with the above charge, this charge was ultimately struck out by consent following the three accused pleading guilty to other charges involved in this case.

    Verdict:
    Other
    Legislation / Statute / Code:

    Medicinal Products (Control of Manufacture) Regulations 2007 reg 14B

    Charge details:

    Falsified medicinal products and excipients

    The fourth charge, Charge No 1 of Case No S:2018/2039, concerned the importation into Ireland, on or about 5 March 2016 of a medicinal product (namely ‘Afhlan (Melphalan Injection USP 50mg)’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product.

    The factual background to this charge was the importation into Ireland (from outside the EU), export to Kuwait and supply by wholesale of Afhlan. The Afhlan was dispatched from India by Taj Pharmaceuticals Ltd to Taj Accura in Ireland, and arrived via Istanbul Airport, Turkey. Whereas the customs declaration for this shipment stated that Ireland was the final destination, upon the arrival of the shipment, the consignment was, on the instructions of Taj Pharmaceuticals Ltd, relabelled to show that the consignee was now a company in Kuwait, Mezzan Holdings, Jazzam Al-Wazzan & Son General Trading Co WLL (‘Mezzan Holdings’). Mezzan Holdings was purchasing the medicinal product for supply to the Kuwaiti Ministry of Health. The consignment was then dispatched to Kuwait via Istanbul. When it was dispatched, the export documentation falsely stated that the country of origin of the product was Ireland and that its final destination was Kuwait.

    The defendants had earlier made other misrepresentations as to the source of the medicinal product. In October 2015, Defendant 2, in response to an enquiry by Mezzan Holdings on behalf of the Kuwaiti Ministry of Health about the manufacturer and country of origin of the Afhlan, sent an email to Mezzan Holdings stating that the product was manufactured by Taj Pharma (UK) Ltd and that its country of origin was Ireland. Defendant 2 did this knowing this information to be false. In November 2015, Taj Accura emailed a Certificate of Analysis for the product in circumstances where it knew, or had sufficient grounds to suspect, that the product was a falsified medicine. This was because the defendants knew that: (a) Taj Accura did not have the authority to hold a marketing authorisation for the product; (b) Taj Accura did not have the authority to issue a Certificate of Analysis (since it did not hold a Manufacturer’s Authorisation); (c) that Taj Pharma (UK) Ltd did not manufacture anything and did not hold a Manufacturer’s Authorisation; and (d) that the country of origin of the medicinal product was India, not Ireland.

    Further misrepresentations made by the defendants included an email sent to Mezzan Holdigns by Defendant 2 in January 2016 which listed the country of origin as Ireland and an email dated 5 March 2016 which contained a fraudulent Manufacturer’s Licence number, a Certificate of Analysis which falsely listed the manufacturer as Taj Accura, and other documents falsely stating the same information.

    The three accused pleaded guilty to this charge and were convicted. The court adjudged that the offence be taken into consideration with the order(s) imposed in relation to Charge No 1 of Case No S:2018/2017.

    Legislation / Statute / Code:

    Medicinal Products (Control of Manufacture) Regulations 2007 reg 14B

    Charge details:

    Falsified medicinal products and excipients

    The fifth charge, Charge No 2 of Case No S:2018/2039, concerned the export from Ireland, on or about 5 March 2016, of a medicinal product (namely ‘Afhlan (Melphalan Injection USP 50mg)’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product.

    The factual background to this charge was the same as the factual background set out in the fourth charge, Charge No 1 of Case No S:2018/2039, above. The order of the District Court of Ireland of 22 June 2018 appears to state both that the accused pleaded guilty to the offence and that the charge was struck out.

    Legislation / Statute / Code:

    Medicinal Products (Control of Wholesale Distribution) Regulations 2007 reg 14B

    Charge details:

    Falsified medicinal products

    The sixth charge, Charge No 3 of Case No S:2018/2039, concerned the sale by wholesale, on or about 5 March 2016, of a medicinal product (namely ‘Afhlan (Melphalan Injection USP 50mg)’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product.

    The factual background to this charge was the same as the factual background set out in the fourth charge, Charge No 1 of Case No S:2018/2039, above. The three accused pleaded guilty to this charge and were convicted. It was adjudged that the offence be taken into consideration with the order(s) imposed in relation to Charge No 1 of Case No S:2018/2017.

    The sixth charge, Charge No 3 of Case No S:2018/2039, concerned the sale by wholesale, on or about 5 March 2016, of a medicinal product (namely ‘Afhlan (Melphalan Injection USP 50mg)’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product.

    The factual background to this charge was the same as the factual background set out in the fourth charge, Charge No 1 of Case No S:2018/2039, above. The three accused pleaded guilty to this charge and were convicted. It was adjudged that the offence be taken into consideration with the order(s) imposed in relation to Charge No 1 of Case No S:2018/2017.

    Verdict:
    Guilty
    Legislation / Statute / Code:

    Medicinal Products (Control of Placing on the Market) Regulations 2007 reg 39

    Charge details:

    Prohibitions in relation to falsified medicinal products

    The seventh charge, Charge No 4 of Case No S:2018/2039, concerned the placing into circulation, on or about 5 March 2016, of a medicinal product (namely ‘Afhlan (Melphalan Injection USP 50mg)’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product, contrary to reg 39(b) of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007.

    The factual background to this charge was the same as the factual background set out in the fourth charge, Charge No 1 of Case No S:2018/2039, above. This charge was struck out by consent following the three accused pleading guilty to other charges involved in this case.

    Verdict:
    Other
    Legislation / Statute / Code:

    Medicinal Products (Control of Placing on the Market) Regulations 2007 reg 39

    Charge details:

    Prohibitions in relation to falsified medicinal products

    The eighth charge, Charge No 5 of Case No S:2018/2039, concerned the introduction into Ireland, on or about 5 March 2016, of a medicinal product (namely ‘Afhlan (Melphalan Injection USP 50mg)’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product, contrary to reg 39(c) of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007.

    The factual background to this charge was the same as the factual background set out in the fourth charge, Charge No 1 of Case No S:2018/2039, above. The three accused pleaded guilty to this charge and were convicted. It was adjudged that the offence be taken into consideration with the order(s) imposed in relation to Charge No 1 of Case No S:2018/2017.

    Verdict:
    Guilty
    Legislation / Statute / Code:

    Medicinal Products (Control of Placing on the Market) Regulations 2007 reg 39

    Charge details:

    Prohibitions in relation to falsified medicinal products

    The ninth charge, Charge No 6 of Case No S:2018/2039, concerned the sale of a medicinal product (namely ‘Afhlan (Melphalan Injection USP 50mg)’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product, contrary to reg 39(d) of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007.

    The factual background to this charge was the same as the factual background set out in the fourth charge, Charge No 1 of Case No S:2018/2039, above. This charge was struck out by consent following the three accused pleading guilty to other charges involved in this case.

    Verdict:
    Other
    Legislation / Statute / Code:

    Medicinal Products (Control of Wholesale Distribution) Regulations 2007 reg 14B

    Charge details:

    Falsified medicinal products

    The tenth charge, Charge No 1 of Case No S:2018/2056, concerned the sale by wholesale, between 23 March 2016 and 5 April 2016, of a medicinal product (namely ‘Afhlan (Melphalan Injection USP 50mg)’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product.

    The factual background to this charge was the sale by wholesale of Afhlan to a UK company, Client Pharma Ltd, a legitimate UK pharmaceutical company. Client Pharma Ltd paid Taj Accura in advance on 1 April 2016; however, after completing due diligence checks, it notified Taj Accura that it wished to cancel its purchase and Taj Accura refunded the purchase money on 6 April 2016. The charges relating to these events included knowingly false misrepresentations that the medicinal product was made by Taj Pharma (UK) Ltd. Taj Accura also supplied Client Pharma Ltd with a photo of packaging of its products which falsely listed the address of an unrelated licensed pharmaceutical company in the UK as the address of Taj Pharma (UK) Ltd.

    The order of the District Court of Ireland of 22 June 2018 does not expressly state whether the accused pleaded guilty to this offence and whether they were convicted, but appears to suggest that they were convicted of the offence because it states that it was adjudged that the offence be taken into consideration with the order(s) imposed in relation to Charge No 1 of Case No S:2018/2017.

    Legislation / Statute / Code:

    Medicinal Products (Control of Placing on the Market) Regulations 2007 reg 39

    Charge details:

    Prohibitions in relation to falsified medicinal products

    The eleventh charge, Charge No 2 of Case No S:2018/2056, concerned the sale between 23 March 2016 and 5 April 2016, of a medicinal product (namely ‘Afhlan (Melphalan Injection USP 50mg)’, a prescription-only medicinal product) in circumstances where the defendants knew or there were sufficient grounds to suspect that it was a falsified medicinal product, contrary to reg 39(d) of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007.

    The factual background to this charge was the same as the factual background set out in the tenth charge, Charge No 1 of Case No S:2018/2056, above. The order of the District Court of Ireland of 22 June 2018 appears to state both that the accused pleaded guilty to the offence and that the charge was struck out.

    Verdict:
    Other
    Fine / Payment to State:
    1000  EUR 

    Taj Accura was ordered to pay a fine of EUR 1000.

    Defendant:
    Defendant 2
    Charge details:

    Defendant 2 was charged with, and convicted of, the same offences as Taj Accura.

    Fine / Payment to State:
    1000  EUR 

    Defendant 2 was ordered to pay a fine of EUR 1000.

    Defendant:
    Defendant 3
    Charge details:

    Defendant 3 was charged with, and convicted of, the same offences as Taj Accura.

    Fine / Payment to State:
    1000  EUR 

    Defendant 3 was ordered to pay a fine of EUR 1000.

    Court

    District Court

    Sources / Citations

    Health Products Regulatory Authority v Taj Accura Pharmaceuticals Ltd (DC, 22 June 2018)