AESGP Backs OTC Devices As EU Advances Legislation
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OTC24-07-15p1_OTC15/11/2005 p1&24 21/07/2015 12:26 Page 1 24 July 2015 COMPANY NEWS 2 AESGP backsOTC devices Consumer Healthcare unit 2 gets anew home at Sanofi Ciplatospin-offOTC operations 2 as EU advances legislation Future of P&G’s OTCbrands 3 almostsecureascullends EU to rule on Mylan/Perrigo 3 elf-caremedical devices in Europe are nasal sprays and throat lozenges, in the high- Sonce morefacing the threat of being est-risk category and argued that this proposal J&Jready for consumer opportunities 4 classified in the highest risk category –class was“neither appropriatenor justified by the ChinaNepstar’schairman 6 III–under fresh proposals by the European risk profile” of these products (OTC bulletin, to acquire drugstorechain Council of European Union (EU) Health 18 December 2012, page 10). Vemediagrows Belgianportfolio 6 Ministers. But the Association of the Euro- Six months later,the parliament’senviron- WBAonthe look out for acquisitions 7 pean Self-Medication Industry,the AESGP, ment, public health and food safety (ENVI) Manufacturingshake-up 8 said it would continue to resist such amove. committee proposed amassive 762 amend- behind RB’srise The Council had recently expanded the scope ments to the legislation, on top of the 145 that Fidiagetsmarketing rights 9 of Rule 21 in AnnexVII of the proposed medi- had been proposed by the legislation’sthen to Halykooportfolio in Italy cal-device legislation, the AESGP pointed out, rapporteur Dagmar Roth-Behrendt (OTC bul- Deliveriesliftsales at Probi 9 despite the European Parliament voting last letin,31May 2013, page 14). year to remove the rule (OTC bulletin,25April The European Parliament backed anumber GENERAL NEWS 10 2014, page 13). of the suggested changes in aplenary vote Label warnings for NSAIDs 10 last April, including the deletion of Rule 21 strengthened by US FDA New language hits OTC devices and of the need to comply with medicines legis- ASMI hits out at review 11 In newlanguage put forward by the Coun- lation, Directive 2001/83/EC. of advertising for OTCs cil, Rule 21 in AnnexVII would cover“all The AESGP said it would also focus its Canada looksat 11 devices that are introduced into the human lobbying efforts in the lead up to and during paracetamol cut body via abody orifice or applied on skin”, the the trilogue discussions on ensuring that de- mHealth is not amagic wand 12 AESGP said, in amove that would mean num- vices were subject to “reasonable requirements for Europe erous self-care medical devices would unnec- without referring to the pharmaceutical legis- NZ says no to oral 13 essarily come under the definition. lationand with no involvement from the Euro- contraceptiveswitch In addition,the classification depended on pean Medicines Agency(EMA)”. ill-defined terms such as ‘systemically absorb- Developing adequate rules for biologically- MARKETING NEWS 14 ed’, ‘not absorbed’ and ‘locally dispersed’, the viable substances would also be on the AESGP’s RB pairs with UK charityto 14 association pointed out. agenda, it added, along with the debate around driveheadache awareness The wider scope of Rule 21 wasone of a putting nano materials in only Class III in spec- Daiichi Sankyo adds to 15 number of Council proposals that could have ifically defined circumstances. LoxoninSrangeinJapan far-reaching consequences for the OTCmedi- Furthermore, the associationsaid it would GSKsupports FenbidinChina 15 cal devices industry,the AESGP argued. Its work to makesure that wheneverthere wasa Medical Devices Committee wasurgently re- “change concerning specific substances”, an Brand heritageis 16 keytorelaunch viewing the latest proposals ahead of trilogue adequate consultation took place and that the discussions on the legislation between the Coun- Unique Device Identifier system would only Elder outlines Shelcalplans 17 cil, the European Commission (EC) and Euro- be applied to substance-based medical devices Doc Ibuprofen campaign 18 pean Parliament, which were expected to begin in “well-justified cases”. highlightsproduct’sspeed in September. FEATURES 20 In its draft proposal, filed in 2012, the EC Position paper expected soon had noted that the line between medicinesand Details of the association’sapproach would France looks towards 20 medical devices was“difficult to draw”. nowbedeveloped into aposition paper,the Spanish model It then suggested –under Rule 21 in Annex AESGP said, which would be finalised by the VII –that substance-based medical devices end of July. REGULARS should be classified in the highest-risk class The AESGP noted that the Council’sprep- Events – Our regularlisting 19 as this wasappropriate to ensure ahigh level aratory bodies were nowlooking at the tech- People – WBAnames Pessina 23 of safety,regardless of their use. nical inconsistences and recitalswith aview as chiefexecutive officer The AESGP warned that Rule 21 would to reaching acomplete general approach by place manyself-care medical devices, such as the end of the summer. OTC24-07-15p2-9_Layout 1 21/07/2015 15:33 Page 2 OTC COMPANY NEWS BusinessStrategy BusinessStrategy ConsumerHealthcareunit Cipla to spin-off getsanew home at Sanofi OTC operations ndia’sCipla is set to spin-offits consumer anofiisset to transfer its Consumer Health- Ihealthcarebusiness into awholly-owned Scare division into anewly-created global subsidiary,inamove the generics firm claims business unit on 1January 2016, as part of a will enable it to takeadvantage of the “shift shake-up instigated by the French firm’schief towardswellness and self-care”. executive officer,Olivier Brandicourt. Noting that its board had approvedthe plans, The General Medicines and Emerging Mar- Cipla said it expected the transfer to be com- kets global business unit will house Consumer pleted during the third quarter of 2015. Healthcare, alongside the firm’sEstablished Describing the move as an “exciting develop- Products and Generics operations. “All pharma- ment”, the near US$2 billion- (C1.8 billion-) ceutical businesses in Emerging Markets” will turnoverfirm said it would nowtodevelop con- also be in the newunit. sumer healthcare as a“strong, customer-focused General Medicines and Emerging Markets business with operational independence”. is to be led by executive committee member, Sanofi’s vice-president of global commercial By operating independently,the consumer Peter Guenter,who has for the past twoyears operations, Peter Guenter,istolead the company’s healthcarebusiness would also be in abetter served as Sanofi’svice-president of global com- newly-created General Medicines and Emerging position to “develop expertise” in the fast-mov- mercial operations. Markets global business unit ing consumer goods (FMCG) segment, Cipla said. Four other global business units will also Earlier this year,Brandicourt promised to While the business would initiallyonly op- be created: SanofiGenzyme, headed by David conduct afull strategic reviewofthe company, erate in its domestic market, aspokesperson Meeker,which will cover‘speciality care’; San- including the Consumer Healthcare division, to forCipla told OTC bulletin that the firm had ofiPasteur for vaccines, which will continue “understand the challenges and opportunities” not ruled out geographic expansion. to be led by Olivier Charmeil; Merial animal that lay ahead for Sanofi(OTC bulletin,22 “Upon achieving significant scale and brand health, which will retain its current chief Car- May 2015, page 7). equity in our home market,”the spokesperson sten Hellmann; and aDiabetes &Cardiovas- Commenting on Brandicourt’sappointment explained, “our consumer healthcareproducts cular unit led by Pascale Witz. shortly after it wasannounced, Vincent Warn- may be launched in other markets where Cip- “The neworganisation simplifies and focuses ery,head of SanofiConsumer Healthcare, said la’s distribution strength and brand equity can Sanofitooptimise growth,”said Brandicourt, he wasconfident that the newchief executive be leveraged.” who has led the firm since April (OTC bul- would be abig supporter of the business (OTC Cipla’sOTC portfolio currently consists of letin, 6March 2015, page 23), following the re- bulletin,3April 2015, page 22), and would one product –smoking-cessation treatment movalofChris Viehbacher by Sanofi’sboard takeanactive interest in Consumer Healthcare. Nicotexnicotine gum –which the company (OTC bulletin,7November 2014, page 1). OTC launched last year into the Indian market. Aswitch from Cipla’sprescription medi- cines business, Nicotexhad already generated sales of INR350 million (C5.10 million) since its launch, the firm pointed out. Noting that Cipla had other consumer health- care products “in the pipeline”, the spokes- person said the companywas planning anum- ber of launches “from next year onwards”. OTC IN BRIEF ■ HI-TECH PHARMACEUTICALS –the US-based sports nutrition firm –has expanded its brand portfolio by acquiring Sports One and its range of premium sports nutrition and diet-aidproducts for an undisclosed sum. Est- ablished in 1990, Sports One had developed a line of “state of the art, high-performance sports supplements”, Hi-Tech claimed, which were “backed by science” and aimed at “hardcore, competitive athletes and fitness enthusiasts”. OTC 2 OTC bulletin 24 July 2015 OTC24-07-15p2-9_Layout 1 21/07/2015 15:33 Page 3 COMPANY NEWS OTC Mergers&Acquisitions BusinessStrategy/Mergers&Acquisitions EU to rule on FutureofP&G’s OTC brands Mylan/Perrigo almost secureascull ends uropean Union (EU) competition regula- Etors will decide by 29 July whether My- he future of Procter